05/10/2011 - Central Drugs Standard Control Organization

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05/10/2011 - Central Drugs Standard Control Organization
Central Drugs Standard Control Organ isation
Directorate
General of Health Services
Ministry of Health & Family Welfare
Food & Drugs Administration Bhawan,
Kotla Road, New Delhi-110002
Date:
t= 5 OCT lDl1
The Commissioner,
Food & Drugs Control Administration,
Gujarat State, Dr. Jivraj Mehta Bhavan,
Block No.8, 1st Floor,
Gandhinagar- 382010.
SUB:- Drugs & Cosmetic Act 1940 & Rules thereunder
Approval for grant of licence in Form 28 along with list of products in
respect of MIs Innovative Ortho- Surgicals Private Limited, E-41, Road
No, 05, Sardar Industrial Estate, Ajwa Road, Vadodara 390019 regarding.
Please refer to your letter no. Mfg/O(!tlollnnovative/CLAAl39720/B dated
02.06.2011 received by this office vide diaryA~TS
38021/2011 dated 11.08.2011
on the subject cited above.
0..
V
Two copies of licence in FOr~,
list of products (Non Sterile Orthopedic
Implant) duly approved by CentrcU~oence Approving Authority (CLAA) are enclosed
herewith for necessary action.
0"
The firm may be jointly inspected periodically and the reports may be
forwarded to this Directorate for Information.
~=._._=--~-~:·.~~~~~.:~~~~~-~:~.~
.•
(Dr. Sul:!I*-c[~[_Singb)
_____-----=_.~••
-----~ ----------
-~----Copy-lorTritOrmation
);>
and necessary action to:-
ert- ~
The Asst. Drugs Controller (I), Sub Zonal Office, Central Drug Standards
Control Organisation, Old Terminal Building, Air Cargo Complex, Airport,
Ahmedabad-380003 GUjarat.
Licence to manuf:
Schedul
1.
PVT. LTD. is
e PLOT NO. 41,
ODARA - 390
DIRECTORS of
hereby granted licen
ROAD NO.5
019.
S
the following drugs being drugs s
in sch. X to the Drugs and Cosmetics
2.
Names of approved competent technical staff:"
3.
The licence authorizes the sale by way of Wholes
sale by the licencee of thed
g~ nl1~~ufac~uredu
applicable to licences for sal
'\
e licensee and storage for
subject to.the conditions
Co
Food & Drugs C
Gujarat State.
Central Licencing Approving Authority
-(;-onditionsofLicence
-.-.--
1•.. TJtjs liceJJj:e.JJndJlny~el't"lCate-of-renewa1in-fofCeSliiln)ekepTon
the approved premises and shall be produced at the
-request of an Inspector appointed under the Drugs and Cosmetics Act, 1940.
2. If the licensee wishes to undertake during the currency of the licence the manufacture of any drug specified in Schedule C
and C(l) (excluding those specified in Schedule X) not included above, he should apply to the Lieensing Authority for the
necessary endorsement as provided in Rule 75(3). This licence will be deemed to extend to the items so endorsed.
3. Any change in the (competent technical staff) shall be forthwith reported to the Licensing
Authority.
4. The licensee shall inform the Licensing Authority in writing in the event of any change in the constitution of the firm
operating under the licence. OWhere any change in the constitution of the firm takes place, the current licence shall be
deemed to be valid for a maximum period of three months from the date on which the change takes place unless, in the
meantime, a fresh licence has been taken from the Licensing Authority in the name of the firm with the changed
.Constitution.)
.
FDCA/GUJARA T128/133
•
d'SPl
Innovative Ortho Surgicals Pvt. Ltd.
(An ISO 9001 :2000 & CE Certified Co.)
Plot No. 41, Road No.5, Sardar Estate, Vadodara- 390 019, Gujarat - INDIA
LIST OF PRODUCTS (NEW MEDIC:
u
.'.
_ ~ URED BY MIS
INNOVATIVE ORTHO SURGICALS PVT. LTD.,
ADDRESS: Plot No 41, Road No 5, Sardar Estate, Ajwa Road, DIST. VADODARA.
GUJARAT,INDIA.
UNDER L1C.IN FORM NO. 28. NO: G/28/1373
GRANTED ON 27-05-2011 WHICH IS VALID UP TO 26-05-2016
NON STERILE ORTHOPEDIC IMPLANTS
BRAND
NAME
1.0, 1.5, 2.0, 2.5,
2.7,3.5,4.5MM
6MMTO
100MM
3.5, 4.0, 5.0,
6.5MM
10MM TO
130MM
20 MM TO
120MM
CANNULATED CANCELLOUS
SC
'(2;(::,BONE
SCREWS
3.0, 3.5,4.0,5.0,
6.5,7.0MM
10MMTO
130MM
2.0,2.7, 3.5,3.8,
4.0, 5.0, 6.5, 7.0
MM
IOSPL
LOCKING BOLT
IOSPL
HIP PIN
IOSPL
INTERFERENCE SCREW
6MM TO
130MM
1.5, 2.0,3.0, 3.9,
4.9,6.0, 6.4, 8.0
MM
10 MM TO
120MM
2.5 MMTO 8.0
30 MM TO
------MTVr----
- ...
5,6,7,8,
9 10
MM
l50t"ftvf 10MM TO
60MM
d'S Pl
I"_"_o_v_a_ti_ve_O_r_th_o_S_u_r9_i_ca_l_s_P_v_t_.
_Lt_d.
(An ISO 9001 :2000 & CE Certified Co.)
Plot No. 41, Road NO.5, Sardar Estate, Vadodara- 390 019, Gujarat - INDIA
LIST OF PRODUCTS (NEW MEDI~L~~1iMl!ACTURED
MIS INNOVATIVE ORTHO SURGICALS PVT. LTD.,
BY
ADDRESS: Plot No 41, Road No 5, Sardar Estate, Ajwa Road, DIST. VADODARA
GUJARAT, INDIA.
UNDER L1C. IN FORM NO. 28~NO: G/28 /1373
GRANTED ON 27-05-2011 WHICH IS VALID UP TO 26-05-2016
NON STERILE ORTHOPEDIC IMPLANTS
IOSPL
DYNAMIC COMPRESSION
PLATE
IOSPL
ROUND HOLE PLATE
IOSPL
LOW CONTACT DYNAMIC
COMPRESSION PLATE
.
2
BONE
PLATES
G
2 HOLE
TO 20
HOLE
1.0 MM TO 5.5 MM
2 HOLE
TO 20
HOLE
1.0 MM TO 5.5 MM
2 HOLE
TO 20
HOLE
1.0 MM TO 2.5 MM
2 HOLE
TO 16
HOLE
2.0 MM TO 4.5 MM
2 HOLE
TO 30
HOLE
2.0 MM TO 6.5 MM
2 HOLE
'\
IOSPL
TUBU~LATES
IOSPL
RECONSTRUCTION
PLATES
IOSPL
1.0 MM TO 5.5 MM
O~<;,
TOLD
ANGLE STABLEPLATE
- --
IOSPL
HIP PLATES
IOSPL
ENDO BUTTONS
'._ ... ------
3.5 MMT08.0
MM
. -HelE·-2 HOLE
TO 20
HOLE
2.5MM
.-
-
•
dSPl
Innovative Ortho Surgicals Pvt. Ltd.
(An ISO 9001:2000 & CE Certified Co.)
Plot No. 41, Road No.5, Sardar Estate, Vadodara- 390019,
GUjarat - INDIA
LIST OF PRODUCTS (NEW MEDI~~_~~ACTUREO
MIS INNOVATIVE ORTHO SURGICALS PVT. LTO.,
BY
ADDRESS: Plot No 41, Road No 5, Sardar Estate, Ajwa Road, DIST.
VADODARA. GUJARAT,INDIA.
,
UNDER LlC. IN FORM NO. 28. NO: G/28 /1373
GRANTED ON 27-05-2011 WHICIi IS VALID UP TO 26-05-2016
NON STERILE ORTHOPEDIC IMPLANTS
IOSPL
FEMUR NAILS
IOSPL
TIBIA NAILS
8,9,10,11,12,13
MM
7,8,9,10,11,.
12MM
IOSPL
HUMERUS NAILS
IOSPL
RADIUS ULNA NAILS
,
.
3
INTERLOC
KING
NAILS
SUPRACO~yU
~\,,-.( ,~
~.
c_'
IOSPL
'.~
NAILS
200MMTO
500MM
200MMTO
450MM
5.0, 5.5, 6.0,6.5,
7.0,7.5, 8.0,8.5,
9.0MM
150MM TO
300MM
1.5,2.0, 2.5, 3.0,
3.5,4.0 MM
100MM TO
400MM
8,9,10,11,12,13
MM
100MM TO
400MM
8,9,10,11,12,13
MM
100MM TO
450MM
8,9,10,11,12,13
MM
100MM TO
450MM
8,_9,19~11
L12->J3.
MM
t5QMMrO450MM
.",.,.,~
Al
IOSPL
IOSPL
IOSPL
-----.-_
.. -----
CTURE FEMUR
NAIL
ALL FRACTURE TIBIA NAIL
-
-
_TBQCHAhlTRIC NAIL-S
----'-
IOSPL
ANKLE NAILS
8,9,10,11,12,13,14
MM
100MM TO
450MM
IOSPL
FIBULA NAILS
2,2.5,3,3.5,4,
4.5MM
100MM TO
450MM
•
dSPL
I_"_"o_v_a_ti_v_e _O_r_th_o__S_ur_9_ic_a_ls_P_vt_" _L_td_"
(An ISO 9001:2000 & CE Certified Co.)
Plot No. 41, Road No.5, Sardar Estate, Vadodara- 390 019, Gujarat - INDIA
Tel. : +91 2652515620 • Fax: +91 265 2515780
email: [email protected] • www.iosplortho.com
LIST OF PRODUCTS (NEW MEDICAL DEVICES) TO BE MANUFACTURED BY
MIS INNOVATIVE ORTHO SURGICALS PVT. LTD.!
ADDRESS: Plot No 41, Road No 5, Sardar Estate, Ajwa Road, DIST.
,
VAI::>ODARA.GUJARAT,INDIA.
__
-------uUNDE-RL~NO---OOF-OO<-..R---M---...-N-...:O---;"
"'-;N~O~:
~G~/2:-:':8--;/1:-:3~7;::-3--~
------
2;;;0.;8---"
GRANTED ON 27-05-2011 WHICH IS VALID UP TO 26-05-2016
NON STERILE ORTHOPEDIC IMPLANTS
KWIRES
0.8~1.0, 1.5, 1.8,
2.0, 2.5, 3.0, 3.5,
4MM
50MM TO
300MM
THREADED WIRES
0.8,1.0,1.5,1.8,
2.0,2.5, 3.0, 3.5,
4MM
50MM TO
300MM
IOSPL
IOSPL
IOSPL
TAPERED THREA~~PINS
...(,:.CO'
PINS &
WIRES
4
40~'
50MM TO
300MM
1.5,2,2.5,2.7,
3.5,4.5,5,
6.5MM
50MMTO
300MM
e.,;?
{
\yV;~
\) SCHANZ PINS
IOSPL
1.5,2,2.5,2.7,
3.5,4.5,5,
6.5MM
1.5, 2, 2.5, 2.7,
IOSPL
---~
---'---
--
----
-
~
-
---
-
,-~-",,-----,----_.-"
..-.-----.
._.----
IOSPL
OTHERS MISC. WIRES
,,-----
-"
-
_ ....
-~
--
--~--
- --
--
-
~
6.5MM
--
~-
S T PINS
-
- - --
---'-_.-'--
--"-
100MM TO
_~3-,5._45,-51
~~- ---------
1.5,2,2.5,2.7,
3.5,4.5,5,
-6.5MM
~-500Mf\.f
,-
~
,
-
------
-
50MM TO
300MM
-
•
d'S Pl
ln_n_o_v_a_tiv_e_o_r_th_o_';_s_Ur_9_iC_a_I_S_P_v_t._L_t_d.
(An ISO 9001 :2000 & CE Certified CD.)
Plot No. 41, Road No.5, Sardar Estate, Vadodara- 390 019. Gujarat - INDIA
Tel. : +91 265 2515620 • Fax: +91 265 2515780
email: [email protected]
• www.iosplortho.com
LIST OF PRODUCTS (NEW MEDICAL DEVICES) TO BE MANUFACTURED BY
MIS INNOVATIVE ORTHO SURGICALS PVT. LTD.!
ADDRESS: Plot No 41. Road No 5. Sardar Estate. Ajwa Road, DIST.
VADODARA,HGUJARA T, INDIA.
UNDER LtC. IN FORM NO. 28. NO: G/28 /1373
GRANTED ON 27-05-2011 WHICH IS VAtlD U-P-~-o-~----NON STERILE ORTHOPEDIC IMPLANTS
Central Drugs Standard Control Organisation
Directorate
General of Health Services
Ministry of Health & Family Welfare
Food & Drugs Administration Bhawan,
Kotla Road, New Delhi-110002
The-State Drugs-Controller,
Controlling & Licensing Authority,
Food & Drugs Administration,
Sector -20, Panchkula,
Haryana -134116.
SUB:- Drugs & Cosmetic Act 1940 & Rules thereunder
Approval for additional product I.V Cannula Le Misawa, Symcath, Microflex, &
Paraslife (Duplicate copy) to MIs Mediplus (India) Limited, 1261-1262, MIE
Part - B, Bahadurgarh - 12450.7- regarding.
Please refer to your letter no. 10/100-2Drugs-I-2011n062
dated 05.09.2011
received by this office vide Diary No. FTS 61928/2011 dated 13.09.2011 on the
SUbjectmatter.
r
~
Two copies of list of additional prQd~ I.V Cannula Le Misawa, Symcath,
Microflex, & Paraslife with inserting the.•.~ ~ "Duplicate copy", dUly approved by
Central Licence Approving Autho~<r9~)
are enclosed herewith for necessary
action.
0 'Y.~ ~
The firm may be jointly inspected periodically and the reports may be
forwarded to this Directorate for Information.
(Dr. Surinder Singh)
Drugs Controller General (I)
~f~
~ The Deputy. Drugs Controller (I), Central Drug Standards Control·
Organisation, North Zone, CGO Building -1, Kamla Nehru Nagar, Hapur
Cungi, Ghaziabad -201002.
@~
MEDIPLUS™
An ISO 9001 : 2008 COMPANY
\A
~
..J,../
V
P L I C-PrT E r\.Jl Py
t
A
tf
LIST OF PRODUCT
MEDIPLUS (INDIA) LIMITED
---1261-126-2-MIE-PARTB
BAHADURGARII HARYANA-124507
PRODUCT: I.V.CANNULA
Drug Manufacturing
(FOR EXPORT)
Licence No. 646 B (H) Valid up to 31-05-2012
D(~scription
IV Cannula With Injection Port
12G,13G, 14G, 16G, 17G,
18G, 20G, 22G, 24G, 26G
Misawa
MISAWA MEDICAL DEVICES
# 04-1015 JOO CHAIT COMPLEX
SINGAPORE 420 001
~--
Regd.Office
:
37/5 .
Punjabi Bagh (East).
New Delhi-110026
(INDIA).
Marketing Office: 405-406, 4th Floor, R.G. Trade Tower, Netaji Subhash Place,
Pitampura, New Delhi - 110034
Tel.: +91-11-27353189/47047481,
F~x: +91-11-47082818
E-mail: [email protected]@mediplusdisposables.com
Works: 1261-1262, M.I.E., Bahadurgarh - 124507, Haryana (INDIA)
Tel. : +91'-1276-2672691267629, Fax: +91-1276-268843,
.
• E-l!l~jl: [email protected]'lI:iles.com
Website : ~.mediplusdisposables.com
@U:V
MEDIPLUS™
An ISO 9001 : 2008 COMPANY
MEDIPLUS (INDIA) LIMITED
1261-1262MIEPARTB
BAHADURGARH HARYANA-124507
PRODUCT: I.V.CANNULA (FOR EXPORT)
Description
IV Cannula With Injection Valve
12G, 13G, 14G, 16G, 17Q,
18G, 20G, 22G, 24G, ~
<,
Microflex
vQ~
(",.,~:.iv
~~~~DIPLa;t)
L,
Authorised
Signatory,,!
-~-~"".'
...----------------~~::r~ER s~-------._ ._
.
.
__Dre.~~Drugs..~'1kDIJel-flnd;ar-·e. General f
FD
,0
Health
.
A Bhawan.'
ServiCes
I.
~~ew
Regd. Office:
37/5
Punjabi
.
Bagh (East).
New Delhi-110026
(INDIA)
N
' "ot!a R
Oeih"11DDD2oad,
Marketing Office: 405-406, 4th Floor, R.G. Trade Tower, Netaji Subhash Place,
Pitampura, New Delhi -110034
Tel.: +91-11-27'353189/47047481,
Fax: +91-11-47082818
E-mail: [email protected] [email protected]
Works: 1261-1262, M.I.E., Bahadurgarh - 124507, Haryana (INDIA)
Tel. : +91-1276-267269/267629,
Fax: +91-1276-26884.3,
.
E-mail: [email protected]
Website: wWw.mediplusdisposables.com
:
'~
(i}~
MEDIPLUS··
An /50 9001 : 2000 COMPANY
~ .DvPL,tATE
~pylf
MEDIPLUS (INDIA) LIMITED
1261-1252-MlEPARTB
BAHADURGARH HARYANA-124507
PRODUCT: I.V.CANNULA (FOR EXPORT)
12G,13G, 14G, 16G, 17G,
18G, 20G, 22G, 24G, 26G
For IvlEDIPLUC ~
Authorised
o«'i ..
Uiv.; i b
ry ,
u~:!"'[''':,~o·
t. , ••..•
l
J
PARSLIFE
~e~m
Nit••.....
¢'~&t Sr N
0<;'
opt.
(\.~. _
L...{fP..~r!.:::'.~
-.
O"--UiflC'--'=-'~~-)--OI/
(R.M. Sharma)
State Owg:; Controller
(Cootrollin{l & licensinG Authorityl
food & Drug Admillist-ration. Harvana
__
.__
.
-------3fttrli:l
.••. ~A;:s; ~-
._.
.
1'!?'=-----
..
Dr. SURINDER SINGH
,
~
('ffiQ)/Drugs ~onlroller (Ind.a)
"W''Ul iIm 1W'~"~
'
.
Ole. Genera! of Health Serv.ces
FDA Shawan, Kotla Road,
New Deihi·ll0002
~
. MEDIPLUS (INDIA) LIMITED
Regd. Office :
37/5
Punjabi Bagh (East).
New Delhi-110026
(INDIA)
Works: 1261-1262, M.I.E., Bahadurgarh-124507, Haryana (INDIA)
Tel.: +91-1276-267269/267629,
Fax: +91-1276-268843
E-mail: [email protected]
[email protected][email protected]
Website: www.mepiplusdisposables.com
Central Drugs Standard Control Organisation
Directorate General of Health Services
Ministry of Health & Family Welfare
Food & Drugs Administration Bhawan,
Kotla Road, New Delhi-110002
[;,.5 OCT lOll
The Commissioner,
Food & Drugs Control Administration,
Gujarat State, Dr. Jivraj Mehta Bhavan,
Block No.8, 151 Floor,
Gandhinagar- 382010.
SUB:- Drugs & Cosmetic Act 1940 & Rules thereunder
Approval for manufacturing licence in Form 28 along with list of products in
respect of M/s Mesco Surgical 4-5. Khodiyar Esate,' B/H. Mahalaxmi Mill,
Narol - IsanpurHighway, Narol, Ahmedabad, Distt. Ahmedabad -382405 regarding.
Sir,
f
Please refer to your letter no. Mfg/grent .~esco
Surgical/CLAA/2011/SC2/43715/B1 dated 18.06.2011 received
. s office vide Diary No. FTS42436/201.1 dated 23.06.2011 on the su~~
atter.
Two copies of Licence in For~\~st
duly approved by Central Licenc~roving
for necessary action.
of products and list of technical staff,
Authority (CLAA) are enclosed herewith
The firm may be jointly inspected periodically and the reports may be
forwarded to this Directorate for Information.
.'
__ ___ ____(Dr.Surlnder-Slngh)
Drugs Controller General (I)
~/iJYf~
~ The Asst. Drugs Controller (I), Sub Zonal Office, Central Drug Standards
Control Organisation, Old Terminal Building, Air Cargo Complex, Airport,
Ahmedabad-380003 GUjarat.
Licence to manuf:
Schedule
1.
Mr.
DHAVIN
SURGICAL is her
4-5 KHODIY
ISANPUR HIGHW
NAROL-
DIST
AH-MEDABAD=382
the following drugs being drugs spec)
in sch. X to the Drugs and Cosmetics-Rules
roved & Annexed
, roved & Annexed
3.
w
5.
e licensee and storage for
, subject to the conditions
The licence is suNect to •.!b
be specified in tlierule;~1i t;
194 .
Com
Food & Drugs Control Administration
Gujarat State.
Conditions of Licence
I.
This licence and any certificate of renewal in force shall be kept on the approved premises and shall be produced at the
request of an Inspector appointed under the Drugs and Cosmetics Act, 1940.
2. If the licensee wishes to undertake during the currency of the licence the manufacture of any drug specified in Schedule C
and C(I) (excluding those specified in Schedule X) not included above, he should apply to the Licensing Authority for the
necessary endorsement as provided in Rule 75(3). This licence will be deemed to extend to the items so endorsed.
3. Any change in the (competent technical staff) shall be forthwith reported to the Licensing
Authority.
4. The licensee shall inform the Licensing Authority in writing in the event of any change in the constitution of the firm
operating under the licence. OWhere any change in the constitution of the firm takes place, the current licence shall be
deemed to be valid for a maximum period of three months from the date on which the change takes place unless, in the
meantime, a fresh licence has been taken from the Licens.ing Authority in the name of 'the firm with the changed
Constitution.)
FDCA/GUJARA T/28/134
List Of Product (New Medical Devices) to be manufactured
by M/S. MESCO
SURGICAL Under the category of Schedule C and Cl, Excluding Schedule X at
4/5,
KHODIYAR WAREHOUSE ESTATE, B/H.
MAHALAXMI
AHMEDABAD - 382405 (INDIA) Under the manufacturing
MILL,
NAROL,
license Form No 28
bearing License No G/28/1375
G:18,19~20,21,22,23,
Sterile Scalp Vein Set
24,25
For Single Use Only
FG:8,10,12,14,16,18,
en e Ryle's Tube
20,22
For Single Use Only
FG:4,5,6,7,8,9,10
Sterile Infant Feeding Tube
For Single Use Only
Sterile Mucus Extractor
For Single Use Only
FG:6,8,10,12,14,16,
Sterile Nelaton Catheter
18,20,22,24
For Single Use Only
FG:6,8,10,12,14,16,
Sterile Sunction Catheter
18, MK 60, MK 91
For Single Use Only
FG:6,8, 10,12, 14, 16,
Sterile Uretheral Cath
18,
(Plain and Thurn
trol)
For Single U ~
Y
FG:6,8,10,12,14,16,
Sterile Rect Catheter
18,
(Plain and Thumb Control)
For Single Use Only
Sterile Chest Drainage Catheter
FG:
(Plain and Thumb Control)
16,18,20,22,24,26,28,
'For Single Use Only
30,31,34,36,38,40
.Sljrile...Nasogastr.ie-St-omaEh-T1Jbe------- -F-G·:8;10;12~1~~
r6~18,
For Singlt!.Use Qnly__
- .20,22--- . --
....
~..••.~GSCO"'I '''%
;~'
~';}
/JJ
~lJ
--
:z
~
%
j' :,.'
<en
Q
"£
.-'
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M
~
v:
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,'-':•• i
J"'~/'.e'
v.:-- _~~
\;1\..1""
J
__
-
G'''INDH!N''~'''
~-:.
for~
.
Food & DrugS Control Administration
Gujarat State.
f 3 JUN 201110 I 2 JU,N 2016
List Of Technical Person for New Medical Devices to be manufactured
by M/S.
M/S. MESCO SURGICAL Under the category of Schedule C and Cl, Excluding
Schedule X at 4/5, KHODIYAR WAREHOUSE ESTATE, B/H. MAHALAXMI MILL,
NAROL, AHMEDABAD -382405
(INDIA) Under the manufacturing
license Form
No 28 bearing License No G/28/1375
Sr.No.
1
Name of Person
Mr. Bhavin R. Shah
Section
Qualification
B.Sc. (Chem.)
Approved for
manufacturing medical
devices
Approved
for
Physico
Chemical Testing Section.
Approved for Sterility and
Toxicity Testing,
Pyrogen(LAL) Testing,
Che!T'ical and Physico'rTlicalTesting
B.Sc.(Micro~C~·" . Approved for Toxicity
v
Testing, Pyrogen(LAL)
Testing, Chemical and
Physico-Chemical Testing'
~t(~·
".
-~-_
-:':.---~-:====F
ur--~onir
..
_.
-- --.--
Food & Drugs Control Administration
Gujarat State.
I 3 JUN 20 II tv , 2 J UN 20 16
Central Drugs Standard Control Organisation
Directorate
General of Health Services
Ministry of Health & Family Welfare
Food & Drugs Administration Bhawan,
Kotla Road, New Delhi-110002
Date:
5 OCT lOll
~
The Director of Drugs Control,
359, Anna Saiai, D.M.S campus,
Chennai-600006.
SUB:-
Drugs & Cosmetic Act 1940 & Rules thereunder
Approval for additional product i.e VISIFLEXSQ Intra Ocular Lens for
Export Purpose in respect of Mis Aurolab, No.1, Sivagangai Main Road,
V~erapanjan, Madurai -625020 - regarding.
Sir,
Please refer to your letter no. 9774/01/3/2011 dated 22.07.2011 received by
this office vide Diary No. FTS 5212412011 dated 03.0!3.·.2011on the sUbject matter.
('"'J
",.
Two copies of list of additional product ~0tSIFLEXSQ
Intra Ocular Lens for
Export Purpose (One Product) duly approvgd'prtentral
Licence Approving Authority
(CLAA) are enclosed herewith for nece~ry
action.
e:o\: .~
It",·, "~
The firm may be jointly inspected
forwarded to this Directorate for Information.
periodically
and the reports
.
u
•
•
.u
__
(Dr. Surm er
••
._,
•
may be
__
._.
_
._
_~~9ntroJ~~~)
Copy for Irlformation and necessary action to:-,___
~
mgh
~
__... _
unn_
---
------
•..
The Deputy Drugs Controller (I), CDSCO (South Zone) 2nd Floor, Shasri
Bhawan Annexe 26, Haddow Road, Chennai -6.
~
-
-
•
-
--
---
UST OF. ADDmONAL STERILE PRODUCTS(INTRAOCULAR LENSES) PERMIITED TO BE
MANUFACTURED FOR SALE BY M/S AUROLAB, NO.1,
SIVAGANGAI MAIN ROAD,
VEERAPANJAN,MADURAI-625 020. IN FORM 28 BEARING NO. TN 00002501 DATED
11/08/2009 VAUD UPTO 10/08/2014.
VISIFLEXSQ
_,.'
.+j~+\.O
with a increment of 1
(Hydrophilic foldable poly hydroxy ethy~ ~
to +30.0 with a increment of 0.5
methacrylate Intraocular lens [email protected]
+31.0 to +40.0 with a increment of 1
haptic & square edge)
0<C"
Central Drugs Standard Control Organisation
Directorate General of Health Services
Ministry of Health & Family Welfare
Food & Drugs Administration Bhawan,
Kotla Road, New Delhi-110002
~ 5 OCT ZOl1
Ihe_CommjssIoner,
Food & Drugs Control Administration,
GUjarat State, Dr. Jivraj Mehta Bhavan,
Block No.8, 15t Floor,
--------~G~andhinaga_r~t9-.
----------~----------~
SUB:- Drugs & Cosmetic Act 1940 & Rules thereunder
Approval for additional product Le Intra Ocular lens in respect of Mis
Biotech Vision Care Pvt. Ltd, Plot no. 555, 556, 557, Khatraj- Vadsar
Ro.ad,At & Post Khatraj, Tal. Kalol, Distt. Gandhi Nag~r - regarding.
Please refer to your letter no. AP/BIOTECH/2011/HC/25886
dated 06.04.2011
and the firm submission dated 16.06.2011 received by this office vide Diary No. FTS23945/2011 dated 13.04.2011 and Diary No. .,29013 (FTS-40082/2011)
dated
16.06.2011 on the subject matter.
«'2 ~
., tV
.J
Two copies of list of additional f>(O~Ucts(Total 07 Products) duly approved by
Central Licence Approving Auth~tclAA)
are enclosed herewith for necessary
action.
!f)"
The firm may be jointly inspected periodically and the reports may be
forwarded to this Directorate for Information.
---------------------------
---------
- - .-------
------- ------------(-Gr. urinder-Singh )-(),~rugs Controller General (I)
Copy for Information and necessary action to:-
~#
_
~ The Asst. Drugs Controller (I), Sub Zonal Office, Central Drug Standards
Control Organisation, Old Terminal Building, Air Cargo Complex, Airport,
Ahmedabad-~80003 Gujarat.
List of products to be manufactured by Mis Biotech Vision Care Pvt. Ltd, Plot No. 555, 556,
557, Khatraj- Vadsar Road, Khatraj, Tal: Kalol, Dist. Gandhinagar, Gujarat, India. Specified in
schedule C and C (1), excluding schedule X under License No. G1l298, in Form No; - 28
Similar Product is counter signed by CLAA, New Delhi
For Domestic Use Only
~ FirstBrand: BIOVISION
1. PMMA INTRA OCULAR LENSES (NON -FOLDABLE CATEGORY) (Sterile)
INDO AMERICAN
(As Second Brand)
Clear and Yellow PMMA Intra Ocular Lenses (Single Piece & Multipiece)
Intra Ocular Lens with Optic Diameter between 5 mm to 7 mm
And overall body Diameter between 12 - 13.5mm
Power Range: -10 to 40 (with 0.5 Diopter Increment) .
Dialing Holes: In Multi Piece: 2 Holes, In Single Piece: No Holes
. :Resolution:MonofocalandMlIltifocaI,SJmerical
Optic Design: Bioconvex
---~-~---~~-----
2. PMMA INTRA OCULAR LENSES (NON -FOLDABLE CATEGORY) (Sterile)
q:.EAR VISION
.
(As Third Brand)
Clear and Yellow PMMA Intra Ocular Lenses (Single Piece & Multipiece)
Intra Ocular Lens with Optic Diameter between 5 mm to 7 mm
And overall body Diameter between 12 - 13.5mm
Power Range: -10 to 40 (with 0.5 Diopter Increment)
Dialing Holes: In Multi Piece: 2 Holes, In Single Piece: No Holes
Optic Resolution: Monofocal and Multifocal, Spherical
Optic Design: Bioconvex
3. PMMA INTRA OCULAR LENSES (NON -FOLDABLE CATEGORY) (Sterile)
KATRIOL
(As Fourth Brand)
Clear and Yellow PMMA Intra Ocular Lenses (Single Piece & Multipiece)
Intra Ocular Lens with Optic Diameter betWeen5 mm to 7 mm
And overall body Diameter be~ee!02Y13.5mm
Power Range: -10 to 40..(wlt1(~r'Diopter Increment)
Dialing Holes: In MUltNl~e: 2 Holes, In Single Piece: No Holes
Optic Resolution: Monofocal and Multifocal, Spherical
Optic Design: Bioconvex
~ FirstBrand:EYECRYL
,,- --------"
. 4. HYDROPHILIC ACRYLIC FOLDABLE INTRA OClJLAR LENSES (Sterile)
BIOCRYL
(As Second Brand)
Clear and Natural Yellow Hydrophilic Acrylic Foldable Intra Ocular Lens
----- --1Single Piece f-----------------------------~---------'--'~-------,------- - - ----IntraOcular Lens with Optic Diameter between 4.4-7.0 mm
And overall body Diameter between 8.4 mm and 14;0 mm
Power Range: -10 to 40 (with 0.5 Diopter Increment)
Dialing Holes: No Holes
Optic Resolution: Monofocal and Aspheric
Optic Design: Bioconvex
FOr,C~;::
Food & Qrugs C.ontml [email protected]
GUjarat State'
..
.3 1 MA"R tOll
---------
List of products to be manufactured by MIs Biotech Vision Care Pvt. Ltd, Plot No. 555, 556,
557, Khatraj- Vadsar Road, Khatraj, Tal: Kalol, Dist. Gandhinagar, Gujarat, India. Specified in
schedule C and C (1), excluding schedule X under License No. G/1298, in Form No; - 28
Similar Product is counter signed by CLAA, New Delhi
For Domestic Use Only
5. HYDROPHILIC ACRYLIC FOLDABLE INTRA OCULAR LENSES (Sterile)
EYECRYL ACTV
1st Brand
Diffractive Natural Yellow Hydrophilic Acrylic Foldable Multifocal Intra Ocular Lens
with Delivery System (Single Piece)
Intra Ocular Lens with Optic Diameter 4.4 -7.0 mm
And overall body Diameter between 8.4 mm and 14.0 mm
~er-Range:---le-te-4e-{with~5-[)iopter-lner~ment1----------------.-----.-----------~-.
Dialing Holes: No Holes
Optic Resolution: MultifocalandAspheric
Optic Design:Refractive-DeffractiveModifiedAsphericSurface
~ First Brand:EYECRYL
6. HYDROPHILIC ACRYLIC FOLDABLE INTRA OCULAR LENSES (Sterile)
EYECRYL-NUCRO
3wBrand
Clear and Natural Yellow Hydrophilic Acrylic Foldable Micro Incision Intra Ocular Lens
(Single Piece)
Intra Ocular Lens with Optic Diameter between 4.4 -7.0 mm
And overall body Diameter between 8.4 mm and 14.0 mm
Power Range: -10 to 40 (with 0.5 Diopter Increment)
Dialing Holes: No Holes
Optic Resolution: Monofocal
Optic Design:Bioconvex
7. HYDROPHILIC ACRYLIC FOLDABLE IN1;'RAOCULAR LENSES (Sterile)
EYECRYL-MULTIFOCAL
,'_ " ,
4th Brand
Clear and Natural Yellow Hydrophilic ~cf.ylic Foldable Intra Ocular Lens (Single Piece)
Intra Ocular Lens with Optic Di~
b-etween4.4 -7.0 mm
And overall body Diameter bee\~r4
mm and 14.0 mm
Power Range: -10 to 40 (~"b.5 Diopter Increment)
Dialing Holes: No Holes 'Optic Resolution: Multifocal
Optic Desi2n:Bioconvex
DECLARATION
The above are the products to be manufactured by us at present. Any addition or deletion, there
to shall not be done_~l!h_~l!!.pTi.2!~ernlis~iQIl
of t!!~_~.Jll..!!!is§.iQ!l~r,f<:)oci_~
J?~g~C::QIl.trQl(lI1_ci
__
Administration, Gujarat State Gandhinagar.
~.
AuthOY
Signatory
~
For, Commissioner,
Food & Drugs Control AcfV7fnisfrafio;,.
Gujara,t Sl?te
..
~ 1 MilD ?n11
Central Drugs Standard Control Organisation
Directorate
General of Health Services
Ministry of Health & Family Welfare
Food & Drugs Administration Bhawan,
Kotla Road, New Delhi-110002
~ 5 OCT 2011
The Drugs Licensing & Controlling Authority,
Uttar Pradesh, 9, Jagat Narayan Road
Lucknow - 226001 (U.P).
SUB: Drugs & Cosmetic Act 1940 & Rules thereunder
Approval for grant of licence in Form 28 in respect of MIs Apothecaries SUhdries
Manufacturing Company, F-1, Sector A-2, Tronica City, Loni, District - Ghaziabad
- regarding.
Please refer to your letter'no. Drug/5863/5420 dated 02.09.2011 received by this
officeyide Diary NO.FTS- 60744/2011 dated 08.09.2011 on the subject matter.
Two copies of licence in Form 28, dUly approved by Central Licence Approving
Authority (CLAA) are enclosed herewith for necessary action.
In the light of documents submitted by you the following observation are made;1. The licence does not bear licence number & valic;iityperiod.
2. The licence also does not specify, whether ~~ort
~se or for Domestic use.
In this connection you are requesteQ-.~ £'ecify the licence number & validity
period in Form-28 before issuing.to a~'Af
& forwarded a copy of the same to this
directorate for record purpose
(y'"'
You are also requested to forward triplicate copies of list of products having
details W.r.t. size (length, diameter), components, (If any), shelf life, etc. for approval
under CLAA scheme.
The firm may be jointly inspected periodically and the reports may be forwarded to
this Directorate for Information.
(Dr. urinder Singh)
Drugs Controller General (I)
Copy for Information and necessary action to:-
---:E-tr~
~~
9
~ The Deputy. Drugs Controller (I), Central Drug Standards Control Organisation,
North Zone, CGO Building -1, Kamla Nehru Nagar, Hapur Cungi, Ghaziabad201002..
FORM-28
(See Rules 76)
Licence to manufacture for sale (or for distribution) of drugs specified in Schedule C
and C (1) [excluding those specified in Schedule Xl
1.
MIs Apothecaries Sundries Manufacturing Company, is hereby licenced to manufacture at the
premises situated at F·1, Sector A·2, Tronica City, Loni, Ghaziabad (U.P.) the following drugs specified in
SchedulesC and C (1) [excluding those specified in Schedule Xl to the Drugs and Cosmetics Rules, 1945.
Names of drugs: (each item separately specified): Categories of drugs approved:
Orthopa'edicImplants
Brand Name
-----~~lJ!)PAEDIC
2·
3·
45·
SCREWS
ASCO/Medicor
ORTHOPAEDIC
PLATE
------------------=~_do-------ORTHOPAEDIC
NAILS
·_··do-···
ORTHOPAEDICWIRES
--do--·
ORTHOPAEDIC
PINS
-·-do-6· ORTHOPAEDIC
HIP PROSTHESIS
-·-do-·7· SPINEIMPLANTS
·····do·····
2.
~
-~~---
Nameof approved CompetentTechnicalStaff:
Mr. Nitin Narang
Mr. Assem Narang
Manufacturing Chemist
Analytical Chemist
3. The licence authorises the sale by way of w~.~'i€ d~aling and storage for sale by the licensee of
the drugs manufactured under the I~Su~ct
to the conditions applicable to licence for sale.
4. The licence shall be in force f~r( \ t. .09.2011 to
09.2016.
5. The licence is subject to the conditions stated below and to such other conditions as may be specified
in the Rules for the time being in force under the Drugs and Cosmetics Act, 1940.
-f\
' ~,
~ 0'\.... (A.K.
3~.
.\~
,.:.~,!,.
-----------
~~~
Drug LicensingC
~
~- ':.1 •..>: c;!N~-:l~
m)\ ' .
ControllingAuthority
Utt{K.~
;'/-I;:ll'~~;r~~;;':~"
DnagI L''';8llIing Cum eontroIIingAuthority
Uttar PradeIh
-,: vj Health S\: ' ::()S
; ;~-:-t-q'~:.i·N:?!1, Kot!g ~')'.;'<'
-----!-.-l-e~..jj1iIj,:,
, -
CentralLicen~~App~rAutlionty
Conditions of Liceilcfl
_
1. This licence and any certificate of renewal in force shall be kept on the approved premises and shall be produced at the request of an Inspector
appointed under the Drugs and Cosmetics Act., 1940.
2. If the licensee wishes to undertake during the currency of the licence the manufacture of any drug specified in Schedule C and C (1) [excluding
those specified in Schedule Xl not included above, he should apply to the Ucensing Authority for the necessary endorsement as provided in
Rule 75 (3). This licence will be deemed to extend to the items so endorsed.
3. Any change in the competent technical staff shall be forthwith reported to the Ucensing Authority.
4. (Orr,i;\k4<&,.Q-~_,,~""'!!wtr-0"
5. _Th~
i;j~ Authority in writing in the event of any change in the constitution
WhE,
~)n of the finn takes place, the current licence shall be deemed to I
mori._:_;p-.f,~
.tak.es place unless, in the meantime
fresh licence has bel
the
• ~:···.'iCJtierlstttutlon.
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:
Central Drugs Standard Control Organisation
Directorate General of Health Services
Ministry of Health & Family Welfare
Food
& Drugs Administration
Bhawan,
Kotla Road, New Delhi-11 0002
Date:
'= 5 OCT
2011
The Commissioner,
_
Food & Drugs Control Administration,
Gujarat State, Dr. Jivraj Mehta Bhavan,
Block No.8, 1st Floor,
---------~----GandhiRagar~--382-04-O~. -------~----------SUB:-
-----------------------------~------------
Drugs & Cosmetic Act 1940 & Rules thereunder
Approval
for additional
products
in respect of MIs Sharma
Pharmaceuticals Pvt. Ltd, 444, GIDC Estate, 'Waghodia, Distt. Vadodara 391760- regarding.
Please refer to your letter no. MfglOrtho/SharmalCLAAl66375/B
dated
07.09.2011 received by this office vide Diary No. FTS- 61973/2011 dated 13.09.2011
on the SUbject matter.
Two copies of list of additional products (AOSPL) duly approved by Central
Licence Approving Authority (CLAA) are enclosed here¥'yith for necessary action.
r.,"\\
On scrutiny of list of products" it has be~n ~QX,ed
that the list of products for
"SPCPL" bears some of the componepls which are already approved by this
directorate, Hence you are reques~€tJq eX-amine the same and forward the list of
products only for additional items. T~ 'triplicate copies of list of products for "SPCPL"
are hereby returned for amendment in this regard.
The firm may be jointly inspected periodically and the reports may be forwarded
to this Directorate for Information.
(Dr. Surinder Singh)
Drugs Controller General (I)
COPY
~
for Information and necessary action 10:-
~
A~
The Asst. Drugs Controller (I), Sub Zonal Offi~~~~ral
Control Organisation, Old Terminal Building, Air Cargo
Ahmedabad-380003 Gujarat.
-DrUg Standards
Complex, Airport,
LIST OF ADDITIONAL PRODUCTS (NEW MEDICAL DEVICES) TO BE MANUFACTURED BY
MiS SHARMA PHARMACEUTICAL PVT. LTD., ADDRESS- 444, GIDC INDUSTRIAL
ESTATE, WAGODIA, DIST. BARODA.GUJARAT,INDIA.
UNDER lie. IN FORM NO. 28. NO;G!28!1302,
GRANTED ON 04-05-2009. WICH IS VALID UP TO 03-05-2014
FIFTH BRAND NAME: AOSPl
SR
NO
PRODUCT
BRAND
NAME
1
BONE
PLATES
AOSPL
2.0 MM TO 6.5
MM
02 HOLE TO
20 HOLE
AOSPL
3.5MM
02 HOLE TO
20 HOLE
AOSPL
4.5MM
02 HOLE TO
20 HOLE
AOSPL
4.5MM
02 HOLE TO
20 HOLE
AOSPL
4.5MM
02 HOLE TO
25 HOLE
AOSPL
3.5 MM &4.5
MM
02 HOLE TO
20 HOLE
AOSPL
3.5MM
02 HOLE TO
20 HOLE
3.5MM &4.5
MM
5+2 HOLE TO
5+2QHOLE
AOSPL
------x<JS-PLAOSPL
FURTHER DESCRIBED AS
DISTAL MEDIAL TIBIA LOCKING PLATE
TIBIA mS~TALAtiTEROlA+ERAk--LOCKING PLATE [RIGHT & LEF
T - PLATE LOCKING
y/
Fe.
Food' e.
c.ornrn;:;~~:(.;;':r~(
0rl.lS!: [en::-:: ,",:-':1'ilhti:.liion
Gujarat Soore;
.
-
- :2'5' AUG 2011
LENGTH
~~ ----4.5MM
- - - -WlIDTE-
nr
20_HOLE- 02 HOLE TO
20 HOLE
LIST OF ADDITIONAL PRODUCTS (NEW MEDICAL DEVICES)TO BE MANUFACTURED
M!S SHARMA PHARMACEUTICAL PVT. LTD., ADDRESS- 444, GIDC INDUSTRIAL
ESTATE, WAGODIA, DIST. BARODA.GUJARAT,INDIA.
BY
UNDER lIC.IN FORM NO. 28. NO;G/28/1302,
GRANTED ON 04-05-2009. WICH IS VALID UP TO 03-05-2014
FIFTH BRAND NAME: AOSPl
SR
NO
PRODUCT
BRAND.
NAME
FURTHER DESCRIBED AS
SIZE
LENGTH
02 HOLE TO
20 HOLE
02 HOLE TO
20 HOLE
02 HOLE TO
20 HOLE
02 HOLE TO
20 HOLE
02 HOLE TO
22 HOLE
02 HOLE TO
20 HOLE
02 HOLE TO
20 HOLE
02 HOLE TO
20 HOLE
02 HOLE TO
20 HOLE
02 HOLE TO
20 HOLE
IN DIAl
. B>one.
AOSPL
AOSPL
AOSPL
AOSPL
T - BUTTRESS LOCKING PLATE
L - PLATE LOCKING PLATE [LEFT &
RIGHT]
L - BUTTRESS LOCKING PLATE [LEFT
&RIGH
,
·fe
AOSPL
CLOVERLEAF LOCKING
DISTAL FEMUR LOCKING ~
E [LEFT
&RIG
'
PROXIMAL FE
' 'C CKING PLATE
L
RIGH
PROXIMALF
UR HOOK LOCKING
PLATE LEFT & RIGH
FEMORAL CONDYLAR BUTTERSS
LOCKING PLATE LEFT & RIGHT]
TROCHANTRIC FEMORAL WITH
LOCKED PLATING
AOSPL
PROXIMAL HUMERUS LOCKING PLATE
AOSPL
AOSPL
AOSPL
AOSPL
-------
4.5MM
4.5MM
4.5MM
3.5MM
4.5MM
4.5MM
4.5MM
4.5MM
4.5MM
4.5MM
--~------
-~--
~---~--~-
m.~
SURINDER
r
.
_/
~.
.
'.
For Commissioner
Food & Oru""
Cn t,
.
::JV. _0 ro Adm/llistration
GClarat St.a!e.
~ 5 AUG 2011
~
~~
~
Ol
e
~
SINGH
.
('if'cl)iOrugs Controller {Ind1al
iN! lf8P1·hll~
.
r.eneral 01 Health SerViCeS
Kolla Road,
.11 0002
Bhawan,
FDA NeW
Deihi
LIST OF ADDITIONAL PRODUCTS (NEW MEDICAL DEVICES) TO BE MANU FACTU RED BY
MIS SHARMA PHARMACEUTICAL PVT. LTD., ADDRESS- 444, GIDC INDUSTRIAL
ESTATE, WAGODIA, DIST. BARODAGUJARAT,INDIA.
UNDER lIC. IN FORM NO. 28. NO;G/28/1302,
GRANTED ON 04-05-2009. WICH IS VALID UP TO 03-05-2014
-
SR
NO
BRAND
NAME
FURTHER DESCRIBED AS
lOW PROFilE PROXIMAL HUMERUS
LOCKING PLATE
MEDIAL DISTAL HUMERUS lOCKING
. PLATE LEFT & RIGH
ANATOMICAL DISTAL HUMERUS
lOCKING PLATE lEFT & RIGHT]
lATE RIAL POSTERIOR DISTAL
HUMERUS lOCKING PLATE [LEFT &
RIGH
ANATOMICAL PROXIMAL HUMERUS
lOCKING PLATE lEFT & RIGH
ClEVICAL lOCKING PLATE [lEFT &
RIGH
CLEVIClE HOOK lOCK
LEFT & Qtf
lENGTH
02 HOLE TO
20 HOLE
02 HOLE TO
. 20 HOLE
02 HOLE TO
20 HOLE
3.5MM
2.5 MM & 3.5
MM
2.5 MM & 3.5
MM
2.5 MM &3.5
02 HOLE TO
20 HOLE
02 HOLE TO
20 HOLE
02 HOLE TO
20 HOLE
02 HOLE TO
20 HOLE
02 HOLE TO
20 HOLE
02 HOLE TO
20 HOLE
02 HOLE TO
20 HOLE
02 HOLE TO
20-HOLE
MM
~(.-.:v
RECONSTR
I'IION lOCKING
PLATE
1/3 RD TUBlAR lOCKING PLATE
___________
--..~----------.--SEMI TUBlAR
LOCKING PLATE
3.5 MM
1.5 MM & 2.5
. .MM-
- .. - -·-t5--MM~~:S-·--U21IDLcTO-MM.
20.t-IOLE ..
oS.~
3flttfu ~
~
•
Dr. S'JRINDER
SINGH
,
,
('IIWl)!DruQs Controller (,n~<0,
-rt<n
Ole. General of
~
F
For CO~iO:l
.••r
000 & Drugs .Contiol AdministraliOh
GUJarat St<lte.
'2 5 ~UG 2011'
11Brf-;;.rnr;.~
;!"31t1 S,e'·'.'~-oo
FDA. Shawano KUlla f'.cad,
New De:hl.11 000:
.
LIST OF ADDITIONAL PRODUCTS (NEW MEDICAL DEVICES) TO BE MANUFACTURED
M!S SHARMA PHARMACEUTICAL PVT. LTD., ADDRESS- 444, GIDC INDUSTRIAL
ESTATE, WAGOD/A, DfST. BARODA.GUJARAT,INDfA.
BY
UNDER L1C.IN FORM NO. 28. NO;G/28/1302,
GRANTED ON 04-05-2009. WICH IS VALID UP TO 03-05-2014
SR
NO
PRODUCT
50 he..
P\A.L.
BRAND
NAME
AOsPL
FURTHER DESCRIBED AS
RECONSTRUCTION THICK
LOCKING PLATE
AOSPL
LC·- DCP SMALL PLATE
AOsPL
LC - DCP NARROW PLATE
AOsPL
LC - DCP BROAD PLATE
SIZE [ IN DIA
AOsPL
CALCENIUM LOCKING ~~
D TYPE CALCANI~
'~~ING
P1,.,\~~
P TYPE
- IUM LOCKING
\)~LATE
R TYPE CALCANIUM LOCKING
PLATE
D.H.s LOCKING PLATE
125*,130*,135*,140* UB & SIB
AOsPL
D.C.s, LOCKING PLATE 95*
AOsPL
AOsPL
AOsPL
DISTAL RADIUS LOCKING PLATE
T - OBLIQUE LOCKING PLATE
Aq~PL.__ _ _ ___j'LEE-T&R1GH1']~--~-AOsPL
-
---
~/
..
-
------
~
For Commi.;:;ion€f
Food & Orugs Control Administration
Gujarat State.
2 5 AUG 2011
LENGTH
02 HOLE TO 20
3.5MM
HOLE
02 HOLE TO 20
3.5MM
HOLE
02 HOLE TO 20
4.5MM
HOLE
02 HOLE TO 20
4.5MM
HOLE
sMALL,MEDIUM,LAF
1.5, 2.0, 2.5 MM
GE
sMALL,MEDIUM,LAF
1.5,2.0,2.5 MM
GE
SMALL,MEDIUM,LAF
1.5, 2.0, 2.5 MM
GE
sMALL,MEDIUM,LAF
1.5,2.0,2.5 MM
GE
5.0 MM TO 8.0
02 HOLE TO 20
MM
HOLE
5.0 MM TO 8.0
02 HOLE TO 20
MM
HOLE
-02 HOLE TO 12
3.5MM
HOLE
02 HOL-E TO 12
~
3:5-MM~~- - - - - -~---HOTE
.
c
AOsPL
1
--
~--
- -
LIST OF ADDITIONAL PRODUCTS (NEW MEDICAL DEVICES) TO BE MANUFACTURED
M!S SHARMA PHARMACEUTICAL PVT. LTD., ADDRESS~ 444, GIDC INDUSTRIAL
ESTATE, WAGODIA, DIST. BARODA.GUJARAT,INDIA.
BY
UNDER L1C;INfPRMN_O;28.
NOjG!28!1302,
GRANTED ON 04-05-20Q9. WICH IS VALID UP TO 03-05-2014
-SR'
NO
PRODUCT
BRAND
NAME
8o-ne..
p\,.,. ,L.,
AOSPL
AOSPL
AOSPL
AOSPL
AOSPL
-
FURTHER DESCRIBED AS
DORSAL DISTAL RADIUS L LOCKED PLATE [LEFT & RIGHTI
DORSAL DISTAL RADIUS T LOCKED PLATE
VOLAR EXTRA ARTICULAR
STANDARD LOCKED PLATE [LEFT
&RIGHTI
VOLAR JUXTA ARTICULAR
STANDARD LOCKED [LEf;J'&.
RIGHT]
(. \,J .•
DORSAL DISTAJ:t ,,.... I'S
STRAIGHT I
PLATE
FIBULA
L DISTAL
LOCKING PWE[LEFT & RIGHT
AOSPL
]
AOSPL
FIBULA POSTEROLATERAL
LOCKING PLATE [LEFT & RIGHT]
AOSPL
CERVICAL L,OCKING PLATE
SIZE [ IN'DIA ]
2.4 MM
LENGTH
02 HOLE TO 12
HOLE
02 HOLE TO 12
HOLE
2.4MM
02 HOLE TO 12
HOLE
2.4MM
2.4MM
2.4MM
3.5 MM & 4.5
MM
3.5 MM & 4.5
MM
2.0MM TO
4.0MM
"._.
••••
&
:,or
c::;:z
ugs .Controi f.dminisfral'
GU1lar~.
Ct .)t<lte.
~25 AUG. 2011
Jon.
02 HOLE TO 12
HOLE
02 HOLE TO 12
HOLE
02 HOLE TO 20
HOLE
02 HOLE TO 20
HOLE
25MM TO 100MM
LIST OF ADDITIONAL PRODUCTS (NEW MEDICAL DEVICES) TO BE MANUFACTURED
M!S SHARMA PHARMACEUTICAL PVT. LTD., ADDRESS- 444/ GIDC INDUSTRIAL
ESTATE, WAGODIA, DIST. BARODA.GUJARAT/INDIA:
.··UNPl:RUC, IN FORMNO.-2S. NO;G/2S/i302,..
GRANT:EO ON 04-05-2009.
SR
NO
PROD~CT
BY
-
WICH IS VALID UP TO 03-05-2014
BRAND
NAME
Bone.
5.0 MM TO 8.0
MM
5.0 MMTO 8.0
MM
3.5 MM &4.5
MM
AOSPL
. AOSPL
02 HOLE TO 20 HOLE
02 HOLE TO 20 HOLE
02 HOLE TO 20 HOLE
. 40 MM TO 120 MM
_~-"-~MMJ~A.5_ _
~_':":=81)SPL
AOSPL
AOSPL
AOSPL
AOSPL
- SPOON-PLATES ANGLED PLATE BLADE [R/H,
DC/H
OSTEOTOMI BLADE PLATE
CONDYLAR PLATES 95* WITH
BLADE
SMALL L-PLATE LEFT & RIGHT
F
•
()Od
:v/
. ':or Comm:sslr.1ner
& Orugs Cr......•f ..! ' •• '.
_
.
.J'"
•••:. ;'\wfi'lllllstralion
uUJar'!tStata,
.25 AUG 2011
_
MM
HQl--E-T-0-1-8-HOJ£3.5 MM &4.5
-MM-- - -- -()~-AOLEfO
18 HOLE
4.5MM
4.5MM
02 HOLE TO 20 HOLE
02 HOLE TO 20 HOLE
4.5MM
3.5MM
02 HOLE TO 20 HOLE
02 OLE TO 20 HOLE
LIST OF ADDITIONAL PRODUCTS (NEW MEDICAL DEVICES) TO BE MANUFACTURED
MIS SHARMA PHARMACEUTICAL PVT. LTD., ADDRESS- 444, GIDC INDUSTRIAL
ESTATE, WAGODIA, DIST. BARODA.GUJARAT,INDIA.
BY
UNDER L1C.INFORMNO.
28. NO;<i!28/i302,
GRANTED ON 04-05-2009. WICH IS VALID UP TO 03r05-2014
SR
NO
BRAND
NAME
FURTHERDESCRIBEDAS
SIZE [ IN DIA]
AOSPL
1/3rd TUBULAR PLATES
3.5 MM
AOSPL
SEMI TUBULAR PLATES
4.5 MM
AOSPL
SMALL T -PLATE
3.5 MM
AOSPL
OBLIQUE T- PLATE -LEFT/RIGHT
3.5 MM
AOSPL
T - PLATE
4.5 MM
AOSPL
4.5 MM
AOSPL
4.5 MM
AOSPL
4.5 MM
AOSPL
~~-----
~-~--
-AOSPL
-AOSPL
AOSPL
AOSPL
CLOVERLEAF PLATE
3.5/4.5 MM
LATERAL -rIBIAL HEAD
BUTTRF;$S'p[ATES-=L:E~t1R}GHf- __ --..4.S.MM-____
FEMORAL CONDYLAR BUITRESS
Pl;AfES·-t.Hi"/R1GHT
4~5MM·
DISTAL TIBIAL ANATOMICAL
PLATE -LEFT/RIGHT
4.5 MM
ANATOMICAL HUMERUS PLATEPROXIMAL -LEFT/RIGHT
4.5 MM
ANATOMICAL TIBIAL PLATEMEDIAL PROXIMAL-LEFT/RIGHT
4.5 MM
2 5 AUG lOll
LENGTH .
02 HOLE TO 20
HOLE
02 HOLE TO 20
HOLE
02 HOLE TO 20
HOLE
02 HOLE TO 20
HOLE
02 HOLE TO 20
HOLE
02 HOLE TO 20
HOLE
02 HOLE TO 20
HOLE
02 HOLE TO 20
HOLE
02 HOLE TO 20
HOLE
.Q2_HQ.LEI020
~---HOl-E--~~--02 HOLE TO 20
_.-~HO[E-·
02 HOLE TO 20
HOLE
02 HOLE TO 20
HOLE
02 HOLE TO 20
HOLE
LIST OF ADDITIONAL PRODUCTS (NEW MEDICAL DEVICES) TO BE MANUFACTURED
MiS SHARMA PHARMACEUTICAL PVT. LTD., ADDRESS- 444, GIDC INDUSTRIAL
ESTATE, WAGODIA, DIST. BARODA.GUJARAT,INDIA.
BY
UNDER L1C.IN FORM NO. 28. NO;G/28/1302,
GRANTED ON 04-05-2009. WICH IS VALID UP TO 03-05-2014
SR
NO
r---
BRAND
NAME
PRODUCT
BOl\ep\ • -
AOSPL
AOSPL
FURTHER DESCRIBED AS
ANATOMICAL FEMUR DISTAL
PLATE -LEFT/RIGHT
STAFEE PLATE
SIZE
r IN DIA ]
LENGTH
02 HOLE TO 20
HOLE
1 SOLT TO 5 SLOT
4.5MM
4.5/5.5MM
1.0MM TO,4.5
MM
1.0MM TO,4.5
Mini Bone Plate Continuous Holes
AOSPL
MM
1.0MM TO,4.5
AOSPL
Mini Bone Plate with bar
MM
L Shape Plate 900 with bar (Left!
1.0MM TO,4.5
Right)
MM
AOSPL
0
L Shape Plate 120 Oblique with
1.0MM TO,4.5
bar (Left! Right)
AOSPL
MM
1.0MM TO,4.5
~~~.i
T Shape Plate with bar
MM
AOSPL
1.0MM TO,4.5
T Shape Plat~~~~;(~malll
Bial
AOSPL
MM
1.0MM TO,4.5
X Shape Plate
AOSPL
MM
1.0MM TO,4.5
Y Shape-Plate (Smallf Bial
MM
AOSPL
1.0MM~TO,4.5
--Do.ubJe~:Y...!.!-Shape-P-Jate---~
"-'--·_·.---MM -~--~
.~=:AClSEL-~_____
AOSPL
03 HOLE TO 50
HOLE
03 HOLE TO 50
HOLE
02 HOLE TO 50
HOLE
Mini Bone Plates
2X2 TO 2X50 HOLE
2X2 TO 2X50 HOLE
-ca.")
..
---
_ .. -
~
-AOSPL
Z Shape Pla~te·(Left!Right)
. For:sr/
food & 0
.
..•·.•'~,di::r
rugs .Control Administration
GUJariJt State.
~2S. AUG 20n' .'
2X2 TO 2X50 HOLE
3X2 TO 3X50 HOLE
03 HOLE TO 50
HOLE
03 HOLE TO 50
HOLE
03 -HObE-TO 50
-------------ttO-re----- ~03 HQLET050
HOLE
1.01Vl_IVI.IQ,4.~
MM
~,~
...:..:
~,
~
Dr. SUR'~·~~·~rF:Sif'.lGH
:;j)qf;l I'lzi'.<il' (>Jiffi,"'--" Conl/cUer (Ind,a)
~
,nn
'Flf''";;~
Dte. General o~ ~\::,;.Hr~Services
FDA Shawan, Kotla Road;
New Oeihi ·11 0002
LIST OF ADDITIONAL PRODUCTS (NEW MEDICAL DEVICES) TO BE MANUFACTU RED BY
MIS SHARMA PHARMACEUTICAL PVT. lTD., ADDRESS- 444, GIDC INDUSTRIAL
ESTATE, WAGODIA, DIST. BARODA.GUJARAT,INDIA.
UNDER L1C.IN FORM NO. 28. NO;G/28/1302,
GRANTED ON 04-05-2009. WICH IS VALID UP TO 03-05-2014
SR
NC
PRODUCT
BRAND
NAME
BoY\ep.t'
,.••,
AOSPL
FURTHER DESCRIBED AS
Orbita Plate Continuous
AOSPL
SIZE [ IN DIA]
1.0MM TO,4.5
MM
1.0MM TO,4.5
MM
1.0MM TO,4.5
MM
1.0MM TO,4.5
MM
1.0MM TO,4.5
MM
1.0MM TO,4.5
MM
1.0MM TO,4.5
MM
1.0MM TO,4.5
MM
1.0MM TO,4.5
MM
1.0MM TO,4.5
MM
Holes
Orbita Plate with bar
!
AOSPL
Curved Plate (Left! Right)
AOSPL
Angular Plate 1500 (Left! Right)
AOSPL
Splitfix Plat~
AOSPL
I
fI": -",,;
AOSPL
AOSPL
AOSPL
AOSPL
I·
,
.
-_._----------
.
----------
AOSPL
8~~
[11,."l \
~\.~
vate
\.J •
I Shape Plate
3 Dimensional Bone Plate (3D) Square Segments for 2mm screws
3 Dimensional Bone Plate (3D) Square Segments for 2mm screws
3 Dimensional Bone Plate (3D) Square Segments for 2mm screws
3 Dimensional~BonefICi~J30t~
~ctanguJal-Segriients--for-2.mm-··-
~y
CVlit,,;i ~~;;i;njstrafiO"
~ SAUG 2011'·.
02 HOLE TO 20 HOLE
02 HOLE TO 20 HOLE
02 HOLE TO 20 HOLE
02 HOLE TO 20 HOLE
02 HOLE TO 20 HOLE
02 HOLE TO 20 HOLE
2X2 TO 2X20 HOLE
3X2 TO 3X20 HOLE
4X2 TO 4X20 HOLE
----'I.OMM-l".e,4;-5-_
..
Food ~ Drug:>
. Glii"r~t State.
02 HOLE TO 20 HOLE
..
.
screws
Far r: 0 rr! rn I ,'it S 7 ••: ~'; ~., (
LENGTH'
-
MM
...
__
.
,
..
._-_._---------_
.... _ .._-_.-.-._
2X2 TO 2X20 HOLE
...
-
LIST OF ADDITIONAL PRODUCTS (NEW MEDICAL DEVICES) TO BE MANUFACTURED BY
M!S SHARMA PHARMACEUTICAL PVT. LTD., ADDRESS- 444, GIDC INDUSTRIAL
ESTATE, WAGODIA, DIST. BARODA.GUJARAT,INDIA.
UNDER L1C.IN FORM NO. 28. NOjG!28!1302,
GRANTED ON 04-05-2009; WICH IS VALID UP TO 03-05-2014
SR
NO
PRODUCT
Bone..
-P'A-Ie-
BRAND
NAME
AOSPL
FURTHER DESCRIBED AS
3 Dimensional Bone Plate (3D) Square Segments for 2mm screws
3 Dimensional Bone Plate (3D) Square Segments for 2mm screws
Straight Reconstruction Plate for
Mandible
Angled Reconstruction Plate for
Mandible (Left! Right)
Double Angled Reconstruction
Plate for Mandible
AOSPL
Chin Plate for 2mm screws
AOSPL
AOSPL
AOSPL
AOSPL
"\
AOSPL
Nose Plate;'H'n2Q~e·
,~~%.
AOSPL
~-(,-
..•••••
"'"., .J
~
'PI~te "Y" Shape
""
AOSPL
I
AOSPL
TMJ Condyle Plate (Left! Right)
Angled Reconstruction Plate For
Mandible with TMJ Condyle (Left!
Right)
2 5 AUG 2Q11
SIZE [ IN DIA ]
1.0MM TO,4.5
MM
1.0MM TO,4.5
MM
1.0MM TO,4.5
MM
1.0MM TO,4.5
MM
1.0MM TO,4.5
MM
1.0MM TO,4.5
MM
1.0MM TO,4.5
MM
1.0MM TO,4.5
MM
1.0MM TO,4.5
MM
1.0MM TO,4.5
MM
LENGTH
3X2 TO 3X20 HOLE
4X2 TO 4X20 HOLE
02 HOLE TO 50 HOLE
02 HOLE TO 50 HOLE
4+16+4 TO 4+50+4
HOLE
10 MM bar
02 HOLE TO 20 HOLE
02 HOLE TO 20 HOLE
02 HOLE TO 20 HOLE
02 HOLE TO 20 HOLE
LIST OF ADDITIONAL PRODUCTS (NEW MEDICAL DEVICES) TO BE MANU FACTU RED BY
MIS SHARMA PHARMACEUTICAL PVT. LTD., ADDRESS- 444, GIDC INDUSTRIAL
ESTATE, WAGODIA, DIST. BARODA.GUJARAT,INDIA.
UNDER L1C. IN FORM NO. 28. NO;G/28/1302,
GRANTED ON 04-05-2009. WICH IS VALID UP TO 03-05-2014
SR
NO
2
PRODUCT
BRAND
NAME
NAILS
AOSPL
AOSPL
AOSPL
AOSPL
AOSPL
AOSPL
FURTHER DESCRIBED AS
SIZE [ IN DIA ]
LENGTH
5MM TO 20
INTERLOCKING NAILS
08 CM TO 100 CM
'MM
EASY UNIVERSAL FEMUR NAIL
8MM TO 20
[LEFT & RIGHT]
MM
20 CM TO 50' CM
8MM TO 20
RETROGRADE FEMUR NAIL
MM
15CM TO 50 CM
8MM TO 20
UNIVERSAL FEMUR NAIL SOLID
MM
20 CM TO 50 CM
8MMT020
RECONSTRUCTION NAIL
20 CMTO 50CM
MM
SUPRACONDYLOR~-",
8MMT020
STRAIG.t1r1"
.•
MM
15 CM TO 50 CM
8MMT020
~~
15 CM TO 50 CM
SUPRAC_~.OVLdR NAIL DIMSC
MM
.
,
8MM TO 20
15 CMTO 50 CM
PROXIMAL FEMUR NAIL
MM
8MMT020
UNIVERSAL FEMUR NAIL
15 CM TO 50 CM
CANNULATED
MM
7MM TO 20
UNIVERSAL TIBIA NAIL
MM
20CMT044CM
CANNULATED
7MM T.Q 20
UNIVERSAL TIBIA NAIL SOLID
MM
20 CMT044CM
7MM-T020
c----~a__e-M--'fe-44_eM---EASY-U-NJ-'T--J8l-A-NAI-b--------------MM----
..•
'\
"
--
,'.~
AOSPL
"
:/
.'
AOSPL
AOSPL
AOSPL
AOSPL
-
--
--
--
--At---------O.5P-.L __,.
~;/
p
For Comm!ssloner
~od & Drug, Control Administr,HfOrt
Gttlarat State.
~25 AUG 2011
--
-:gf.~~
Dr. SURINDER
~
SINGH
~
~~
_.
('IT'!1I):Druss Controller (Ind131
~
1'f'M~vrR"f'!1
DIe General of H,,3i\r, "uvlce,
FDA Shawan, Kalla Read.
New Deihi.110002
LIST OF ADDITIONAL PRODUCTS (NEW MEDICAL DEVICES) TO BE MANUFACTURED
MIS SHARMA PHARMACEUTICAL PVT. LTD., ADDRESS- 444, GIDC INDUSTRIAL
ESTATE, WAGODIA, DIST. BARODA.GUJARAT,INDIA.
BY
UNDER L1C.IN FORM NO. 28. NO;G/28/1302,
GRANTED ON 04-05-2009. WICH IS VALID UP TO 03-05-2014
SR
NO
I---
PRODUCT
~&;,
t,.
BRAND
NAME
AOSPL
AOSPL
AOSPL
AOSPL
FURTHER DESCRIBED AS
EXPERT TIBIA NAIL
HUMERUS NAIL CANNULATED
HUMERUS NAIL SOLID
PROXIMAL HUMERUS NAIL
AOSPL
RADIUS ULNA NAIL
AOSPL
ELASTIC NAIL
GAM NAIL [SHORT, LONG LEFT &
RIGHT]
K -NAIL
SQUARE NAIL FOR REDI~~'\('
ULNA
•.••. J
AOSPL
AOSPL
AOSPL
~
AOSPL
~c'"."",
11 ~
J*
ENoe~$.N'~IL
'#
AOSPL
LOCKING BOLT
SIZE [ IN DIA]
7MMTO 20 MM
5MMTO 14MM
5MM TO 14 MM
5MM TO 14 MM
1.5 MM TO
5.0MM MM
1.5 MM TO 5.0
MM
09 MM TO 20
MM
6 MMTO 10MM
1.5 MM TO 5.0
MM
1.5 MM TO 5.0
MM
1.0mm to
16mm
LENGTH
20 CM TO 44 CM
10 CM TO 35 CM
10 CM TO 35,CM
10CMT035CM
06 CM TO 40 CM
06 CM TO 60 CM
18 CMTO 50 CM
08 CMTO 50 CM
08 CM TO 44 CM
08 CM TO 60 CM
10 MM TO 120 MM
"",-:':.
'
.. _,..
...~
..•.
;;' su~~";, ,~ <'1~lGH.
'hft'liU ~.
('TIF..}I. "," Conlrollcr (Ind,a)
~<~ql1'ffilf~
Ole
.F~~Z
FGod & Orugs C
r.," .
, '. on t rol ~':,mml:st;aliotl
GUlarat
State.
·2 5 AUG 2011'
General
of Health
Services
FDA Shawan, Kolla Road,
New Delhi -11 0002
LIST OF ADDITIONAL PRODUCTS (NEW MEDICAL DEVICES) TO BE MANUFACTURED
MIS SHARMA PHARMACEUTICAL PVT. LTD., ADDRESS- 444. GIDC INDUSTRIAL
ESTATE, WAGODIA, DIST. BARODA.GUJARAT,INDIA.
BY
UNDER L1C.IN FORM NO. 28. NO;Gj28j1302,
GRANTED ON 04-05-2009. WICH IS VALID UP TO 03-05-2014
SR
NO
3
PRODUCT
~ONE
SCREW
BRAND
NAME
AOSPL
AOSPL
AOSPL
AOSPL
AOSPL
AOSPL
AOSPL
AOSPL
AOSPL
FURTHER DESCRIBED AS
SIZE [ IN DIA ]
1.5 MM LOCKING BOL T
3.0 MM LOCKING BOLT SN TH
3.7 MM LOCKING BOLT SN TH
3.9 MM LOCKING BOLT SN TH
4.0 MM LOCKING BOLT SN TH
4.9 MM LOOCKING BOLT SN TH
5.0 MM LOCKING BOLT
6.0 MM LOCKING BOLT
CANNULATED
6.0 MM LOCKING BOLT SOLlQ..,,,\.
r
8.0 MCMLOC~I~tOUU
AOSPL
AOSPL
AOSPL
-
AOSPL
AOSPL
AOSPL
AOSPL
10 MM l:OtKING BOLT
12 MM LOCKING BOLT
6.5 MM CANCELLOUS LOCKING
SCREW-[16TH, 32TH F. TH]
2.7 MM1CORTEX LOCKING SCREW
2.4 MM CORTEX LOCKING SCREW
2.0MM LOCKING SCREW
LENGTH
1:5 MM
3MM
3.7MM
3.9MM
4.0MM
4.9MM
5.0MM
10
·10
10
10
10
10
10
MM
MM
MM
MM
MM
MM
MM
TO
TO
TO
TO
TO
TO
TO
120
120
120
120
120
120
120
MM
MM
MM
MM
MM
MM
MM
6.0MM
6.0MM
10 MM TO 120 MM
10 MM TO 120 MM
8.0MM
10MM
12 MM
10 MM TO 120 MM
10 MM TO 120 MM
10 MM TO 120 MM
6.5MM
2.7MM
2.4MM
2.0MM
10 MM TO 120 MM
10 MM TO 120 MM
6 MM TO 60MM
10MM TO 60MM
I
~~
•
,,..,-p, SINGH
Or. SURIN ')'jC
Conlrollo1 (Ind'"'
:>\'tq~~
.
(>Urn Dlug~
~i~
He"llh ·.:.erv'~(.S
Ole. Gener,,1 o~ Kalla RoaC,
~~,
,ij
FOA Bhawa,'
110002
New oe,hl'
Feed&OF~~~
.
rllgs .Contr• 0 I rl4cImir.istrar
.
GUJarat State.
.
Ion
LIST OF ADDITIONAL PRODUCTS (NEW MEDICAL DEVICES) TO BE MANUFACTURED BY
MIS SHARMA PHARMACEUTICAL PVT. LTD., ADDRESS- 444, GIDC INDUSTRIAL
ESTATE, WAGODIA, DIST. BARODA.GUJARAT,INDIA.
UNDER L1C.IN FORM NO. 28. NO;G/28/1302,
GRANTED ON 04-05-2009. WICH IS VALID UP TO 03-05-2014
SR
NO
PRODUCT
BRAND
NAME
FURTHER DESCRIBED AS
SIZE [ IN D/A]
3.0 MM CORTEX LOCKING
SCREW
3.0MM
4.0 MM CORTEX LOCKING
SCREW
4.0MM
5.0 MM CORTEX LOCKING
SCREW
5.0MM
5.0 MM CANCELLOUS LOCKING
SCREW
5.0MM
4.0 MM CANCELLOUS LOCK/N~ '
4.0MM
SCREW
"" ("'V.
'j
J:)Ol\e..
c:::._ , ••
f---
,.1
AOSPL
AOSPL
AOSPL
AOSPL
LENGTH
20 MM TO 120'MM
20 MM TO 120 MM
20 MM TO 120 MM
20 MM TO 120 MM
V
AOSPL
20 MM TO 120 MM
{""> '."•....
V.....
,-t.;
'J( ~ ••
AOSPL
AOSPL
AOSPL
AOSPL
AOSPL
..
-----------_.
-
..
-------------'._---
---
~-
-----AOSPL
-AOSPL
1.0 MM TO
10MM
1.0 MM TO
10MM
2.7MM
CORTICAL SCREWS
CANCELLOUS SCREWS(16TH,32TH,FULL TH,HALF TH)
~7MMCORTICALSCREW
3.5 MM CORTICAL SCREW-14
TPI, 20 TPI
4.0 MM CANCELLOUS SCREW -[
F. TH, H. TH]
4.5 MM CORTICAL SCREW
4.0 MM CANNULA TED
CANCELLOUSSCREW-[F.
TH ,
AOSPL
_ ..
_-_
.. -
-----------_.
__ ....
,-_."-
---H.ltty--
--
5.0 MM CANCELLOUS SCREVV-[
F. TH ,-H: TH]
"'.
rGod&Q
F"r~O~I'
..
"-
.
rug$ ,Control ~~'''.II.)
';rI-'i~I'-traf'IOn
GU/Jrat
State .
.. 2 5 .A'UG 20n'
06 MM TO 120 MM
06 MM TO 120 MM
10 MM TO 120 MM
3.5MM
10 MM TO 120 MM
4.0MM
4.5MM
10 MM TO 120 MM
10 MM TO 120 MM
--~:O-MM-
- - - - -10~MT()12UMM
-
5.0MM
-~_._-_._.-
10 MM TO 120 MM
--
LIST OF ADDITIONAL PRODUCTS (NEW MEDICAL DEVICES) TO BE MANUFACTURED
MIS SHARMA PHARMACEUTICAL PVT. LTD., ADDRESS- 444, GIDC INDUSTRIAL
ESTATE, WAGODIA, DIST. BARODA.GUJARAT,INDIA.
BY
UNDER L1C. IN FORM NO. 28. NO;G/28/1302,
GRANTED ON 04-05-2009. WICH IS VALID UP TO 03-05-2014
SR
NO
PRODUCT
BRAND
NAME
Bo\O\e..
.5c-"Ce....tJ
AOSPL
AOSPL
AOSPL
,FURTHER DESCRIBED AS
5.0 MM CANNULATED
CANCELLOUS SCREW-[ F. TH ,
H.TH
6.5 MM CANCELLOUS SCREW-[
16 TH, 32 TH F. TH
6.5 MM CANNULATED
CANCELLOUS SCREW-[ 16 TH,
32 TH F. TH]
7.0 MM CANNULATED
CANCELLOUS SCREW-[ 32 TH F.
TH
8.0 MM CANNULATED
CANCELLOUS SCREW-[ 32 TH F.
TH
MALLEOLAR SCREW
WASHER
',.)
AOSPL
AOSPL
AOSPL
_ -=-___ __ --~------------
c.~-:
Mini Screws Sin
Mini Screws Sin
Mini Screws Sin
--AOSP-L-- ----MirnSe-r-ews-S-i
AOSPL
Mini Screws Sin
AOSPL
Mini Screws Sin
LENGTH
5.0MM
10 MM TO 120 MM
6.5MM
10 MM TO 120 MM
6.6MM
10 MM TO 120 MM
7.0MM
10 MM TO 120 MM
8.0MM
4.5MM
1.0MM
10 MM TO 120 MM
10MM TO 120 MM
2.0 MM TO 12 MM
1MMTO
Ie Slot Head
3.5MM
Ie Slot Head
1.0 MM
Ie Slot Head
L5_MM
fe--8-fot-Head--------2jTMM---
t~$!Qttl~ad
Ie Slot Head
__.
_2.5_MM_
2.7 MM
04 MM TO 50 MM
04 MM TO 50 MM
04MM T-O-50MM~---o4MM--rO-SO~M_04.MMJ--O-50-MM04 MM TO 50 MM
.~
~
r. SURINDER
SINGH
"
<:-. ~
(1lffil') 'I '''·QS c~ntroller (.ncla\
.>frtfit.oll~q?t",
• ...•••
_
~~
~m
?IT.-'
,
Dte Geceral of hea':,' '.,"
,
FDA Bhawan, Mila Road,
New Delhl-110002
-.m~~
"""""T
LIST OF ADDITIONAL PRODUCTS (NEW MEDICAL DEVICES) TO BE MANUFACTURED
M!S SHARMA PHARMACEUTICAL PVT. LTD., ADDRESS- 444, GIDC INDUSTRIAL
ESTATE, WAGODIA, DIST. BARODA.GUJARAT,INDIA.
BY
UNDER lIC. IN FORM NO. 28. NO;G/28/1302,
GRANTED ON 04-05-2009. WICH IS VALID UP TO 03-05-2014
SR
NO
I-
I
BRAND
NAME
PRODUCT
\Sone..
.s C-..re#.J
FURTHER DESCRIBED AS
Intermaxillary Fixation Screws
(IMF) with hole
Lag Screws Single Slot Head
Emergency Screws Single Slot
Head
AOSPL
AOSPL
AOSPL
SPINAL
IMPLANT
4
AOSPL
r
-
AOSPL
AOSPL
AOSPL
AOSPL
AOSPL
-
AOSPL
----.----'-
-
-
-------------
----.- ...__
... _-----
•...
~~_
.. __
.-
AOSPL
----
-1GE,r:.t- CO~
SPIN-=:
---
-
AOSPL
-
For~
Food & Drugs Control Adrainistralion
Gujarat
State.
2:; AUG 2011"
LENGTH
2.0,2.5 MM
2.0,2.5 MM
1.7,2.3,2.7
MM
"~3.5MM TO
7.5MM
3.5MM TO
7.5MM
3.5MM TO
7.5MM
3.5MMTO
7.5MM
3.5MM TO
7.5MM
3.5MM TO
7.5MM
STEFFEE SCREWS
MONO SACRAL SCREW (SINGEL
LOCK)
MONO SACRAL SCREW (DUBLE
LOCK)
POL Y SACRAL SCREW (SINGEL
LOCK)
POL Y SACRAL SCREW (DUBLE
LOCK)
SPONDYLOLISTHESIS
REDUCTION SCREW (SINGEL
3.5MMTO
LOCK)
7.5MM
SPONDYLOLISTHESIS
___
____
_ 8.I;Q~CIJQN.--SJ~_RE.wlDUJlLE _ ___3_._5M.niLlO
LOCK)
7.5MM
3~OMMTO
ROD
7.0MM
--
-
SIZE [.IN DIA ]
04 MM TO 50.MM
04MMT050MM
04 MM TO 50 MM
20MMT060MM
20MMT060MM
20MMT060MM
20MMT060MM
20MM TO 60MM
20MMTO 60MM
20MMTO 60MM
--
__
20MMTO 60MM
--_.~._-----_. ._-------_ .. -
-
------
-
--
---
.--
-
-
_
.•..
- -
50MM TO 500MM
--
LIST OF ADDITIONAL
MIS
PRODUCTS (NEW MEDICAL DEVICES) TO BE MANUFACTURED
SHARMA PHARMACEUTICAL
ESTATE, WAGODIA,
BY
PVT. LTD., ADDRESS- 444, GIDC INDUSTRIAL
DIST. BARODA.GUJARAT,INDIA.
UNDER L1C. IN FORM NO. 28. NO;G/28/1302,
GRANTED ON 04-05-2009.
SR
NO
PRODUCT
t--
ISf' \"Y\~
-t'""""
.\ .••.0-&-
WICH IS VALID UP TO 03-05-2014
BRAND
NAME
FURTHER DESCRIBED AS
AOSPL
LEMINAR HOOK WIDE
AOSPL
LEMINAR HOOK NARROW
AOSPL
LEMINAR HOOK ANGLE BLADE
UNIQUE LEMINAR HOOK
REDUCED DISTANCE
LEMINAR HOOK REDUCED
DISTANCE
I
AOSPL
AOSPL
AOSPL
AOSPL
AOSPL
-
-- --
.-
--------
PADICLE HOOK
TRANSVERSE PROCESS HOOK
LEFT
TRANSVERSE PROCESS HOOK
RIGHT
-~\Ct
INN I:Hll.
AOSPL
OUTER NUT
AOSPL
STAPPLE
AOSPL
LENGTH
04MM TO 50 MM
04MM TO 50 MM
04 MM TO 50 MM
04 MM TO 50 MM
04MM TO 50 MM
04MM TO 50 MM
04MMT050MM
_n' :»"'"
AOSPL
AOSPL
SIZE [ IN DIA]
3.5MMTO
7.5MM
3.5MMTO
7.5MM
3.5MMTO
7.5MM
3.5MM TO
7.5MM
3.5MMTO
7.5MM
3.5MM TO
7.5MM
3.5MM TO
7.5MM
3.5MM TO
•• 7.5MM
3.5MM TO
7.5MM
3.5MMTO
7.5MM
3.5MMTO
7~5MM
3.5MMrO·
...-... 7~5MM..
3.5MM TO
7.5MM
-
U1lt
v-
TRANSVERSE CONNECTOR ..
AUTO PRE-STRESS
TRANSVERSE CONNECTOR
04MMT050MM
04 MM TO 50 MM
04MM TO 50 MM
..
..
.
-
04MM T050MM
..
.'
04-MMTO -50.MM _
04 MM TO 50 MM
;g'f •. ~~
~
Dr. SUR;'·nf:R
SiNGH
li'Itlf<l f~
'.'F'lilV'ru9' Conlco'ler (lr,;,
.F.r~
Food & Drugs Control4dministrafion
Gujarat State.
.
'-2. 5 AUG ..2011
.
x<m~"';i1 ,;q;IT~"1J"F:'
Dte. General of ~-:,::;_;;:t!) ;!'"
FDA Bha-wan, Kctla Road,
New Delhi -11 0002
LIST OF ADDITIONAL PRODUCTS (NEW MEDICAL DEVICES) TO BE MANUFACTURED BY
MiS SHARMA PHARMACEUTICAL PVT. LTD., ADDRESS- 444, GIDC INDUSTRIAL
ESTATE, WAGODIA, DIST. BARODA.GUJARAT,INDIA.
UNDER L1C.IN FORM NO. 28. NO;G/28/1302,
GRANTED ON 04-05-2009. WICH IS VALID UP TO 03-05-2014
NON STERILE ORTHOPEDIC IMPLANTS
FIFTH BRAND NAME: AOSPL
SR
NC
BRAND
NAME
FURTHER DESCRIBED AS
AOSPL
HARRINGTON ROD
AOSPL
HARRINGTON SHARP
AOSPL
AOSPL
0~;LSCREWS
AOSPL
PCLSCREWS
AOSPL
BUTTON
AOSPL
DISK
2.s AUG 20'"
SIZE [ IN DIA]
05MMTO
10MM
05MMTO
10MM
05MMTO
10MM
05MMTO
10MM
05MMTO
10MM
05MMTO
10MM
05MM TO
10MM
LE~GTH
10MM TO 350MM
10MM TO 350MM
10MM TO 350MM
10MM TO 50MM
10MMTO 50MM
10MMTO 50MM
10MM TO 50MM

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