Producer Formulary_M..

IDENTIFICATION
FORMULARY FOR THE COUNTRY OF ORIGIN
OF THE MANUFACTURER
Name of the medicine / group of medicines: MONOFER
100 mg/ml
No.
1
Required information
Name of the contract manufacturer
Answer
Wasserburger Arzneimittelwerk GmbH
2
Residency (main) country of the
contract manufacturer, regular mail
box address
Country and address of the production
site
Herderstrasse 2
D-83512 Wasserburg a. Inn
Germany
Herderstrasse 2
D-83512 Wasserburg a. Inn
Germany
http://www.reciphann.com/enJ
3
4
5
6
Web page of the contract
manufacturer, if available
EU member states were the
medicine/medicines is/are marketed
Quality System
- Which standard is applied
- Which activities are included in the
above standard
Austria, Denmark, Estonia, Finland, Germany,
Greece, Ireland, Latvia, Lithuania, The
Netherlands, Norway, Poland, Sweden, United
Kingdom, Romania
GMP as certified by the responsible authority
Manufacturing of Human Medicinal Products
and Human Investigational Medicinal Products
for clinical trials, please refer to certificate
Regierung von Oberbayem
7
- The Institution which has issued the
certification
Declaration or Authorization
W 5/0112012
8
- Name of the employee that
Dr. Franz Xaver Huber
undersigns
9
- Position held in the contract
manufacturer company of the above
10
- Contact (phone /fax/e-mail)
Qualified Person
undersignee
[email protected]
Telephone: +49 (0) 8071 1008-0
Telefax: +49 (0) 8071 1008-92
Note:
1. If different products of the same company have different contract manufacturers,
be filled-in for each individual contract manufacturer.
2. All sheets have to be explicitely filled-in by the company.
the table has to
This form has to be signed and stamped by the local contact of Pharmacosmos AlS in Romania
(Ewopharma Romania), therefore please send the filled-in word-document back
Ewopharma AG Romania,
(authorized signature and stamp)
Ewopharmiil AG ucharest
B-dul Prirnava-t, 1, -21,Sc.B
Et 1, Sect rl,011972
Bucure~r
Romar>'-
2
IDENTIFICATION
Name of the medicine/group
of medicines: MONOFER 100 mg/ml
Required information
Name of the contract manufacturer
No.
1
Residency (main) country of the
contract manufacturer, regular mail
box address
Country and address of the production
site
2
3
Web page of the contract
manufacturer, if available
EU member states were the
medicine/medicines is/are marketed
4
5
Answer
Solupharm Pharmazeutishe Erzeugnisse
GmbH
Industriestrasse 3
D-34212 Melsungen
Germany
Industriestrasse 3
D-34212 Melsungen
Germany
http://www.solupharm.de/
Austria, Denmark, Estonia, Finland, Germany,
Greece, Ireland, Latvia, Lithuania, The
Netherlands, Norway, Poland, Sweden, United
Kingdom
Quality System
6
7
8
9
FORMULARY FOR THE COUNTRY OF ORIGIN
OF THE MANUFACTURER
..
- Which standard is applied
- Which activities are included in the
above standard
- The Institution which has issued the
certification
Declaration or Authorization
- Name of the employee that
undersigns
- Position held in the contract
manufacturer company of the above
GMP as certified by the responsible authority
Manufacturing of Human and Veterinary
Medicinal Products, please refer to certificate
Regierungsprasidium Darmstadt
Authorisation: DE-RPDA-001-M-71-2-0
Dr. Helmut Linder
Qualified Person
undersienee
10
- Contact (phone /fax/e-mail)
[email protected]
Telephone: +49 5661 - 730513
Telefax: +49 5661 - 730520
Note:
1.If different products of the same company have different contract manufacturers, the table has to
be filled-in for each individual contract manufacturer.
2. All sheets have to be explicitely filled-in by the company.
This form has to be signed and stamped by the local contact of Pharmacosmos AlS in Romania
(Ewopharma Romania), therefore please send the filled-in word-document back
Ewopharma AG Romania,
(authorized signature and stamp)
Ewopnarma
AG
!
charest
B-dui Primaverii 1 -21.Sc.B
Et1.Sect
Bucurastt
2
1.011972
Roman;c