here - Inventia Healthcare Pvt. Ltd.

Anti
Anti
Diabetic
Diabetic
BE Reference Product
Dossier
Type
CT Data
Availability
DCGI
(Y, N,
IP, NA)
Local FDA
(Y/N)
Commercialization
Status
Gliclazide 30 mg ER Tablets
Diamicron® Gliclazide MR
Tablets 60 mg (Servier,France)
ACTD
N/A
N/A
N
Development
Completed
Gliclazide 60 mg ER Tablets
Diamicron® Gliclazide MR
Tablets 60 mg (Servier,France)
ACTD
N/A
N/A
N
Development
Completed
Glimepiride 1 mg Tablets
N/A
ACTD
N/A
N/A
N
Commercialized in
ROW markets
Glimepiride 2 mg Tablets
N/A
ACTD
N/A
N/A
N
Commercialized in
ROW markets
Glimepiride 3 mg Tablets
N/A
ACTD
N/A
N/A
N
Commercialized in
ROW markets
Glimepiride 4 mg Tablets
N/A
ACTD
N/A
N/A
N
Commercialized in
ROW markets
Y
Commercialized in
India with Abbott
Healthcare, Dr.
Reddy's Lab,
Franco Indian,
Merck, Sanofi,
Sun Pharma
Molecule
Molecule
Metformin HCl 1000 mg SR
+ Glimepiride 1 mg Tablets
N/A
ACTD
N/A
Y
Metformin HCl 1000 mg SR
+ Glimepiride 2 mg Tablets
N/A
ACTD
N/A
Y
Y
Commercialized in
India with Abbott
Healthcare ,
Dr. Reddy's Lab,
Franco Indian,
Merck, Sanofi,
Sun Pharma
Metformin HCl 1000 mg SR +
Methylcobalamin 750 mcg
Tablets
N/A
Non CTD
N/A
IP
Y
Development
Completed
Metformin HCl 1000 mg SR +
Methylcobalamin 1500 mcg
Tablets
N/A
Non CTD
N/A
IP
Y
Development
Completed
Metformin HCl 1000 mg
SR Tablets
N/A
ACTD
N/A
Y
Y
Commercialized in
India with Bayer,
Glaxo, Merck;
ROW markets
Metformin HCl 1000 mg
SR Tablets
Glucophage® XR Metformin HCl
SR Tablets 1000 mg (Merck, UK)
ACTD
N/A
Y
Y
Development
Completed
Metformin HCl 500 mg
SR Tablets
Glucophage® Metformin HCl
XR Tablets 500 mg (BMS, US)
ACTD
N/A
Y
Y
Commercialized in
India with Bayer,
Glaxo,
ROW markets
Daonil® Glibenlamide 5 mg
Tablets (Aventis, India) +
Glucophage®XR Metformin
HCl SR 500 mg Tablets (BMS,US)
ACTD
N/A
Y
Y
Commercialized in
ROW markets
Metformin HCl 500 mg SR +
Glibenclamide 5 mg Tablets
Key: IP: In Progress
Y: Yes
Confidential
N/A : Not Available
N: No
Page 1 of 14
Anti
Anti
Diabetic
Diabetic
BE Reference Product
Dossier
Type
CT Data
Availability
DCGI
(Y, N,
IP, NA)
Local FDA
(Y/N)
Commercialization
Status
Metformin HCl 500 mg SR +
Gliclazide 30 mg SR Tablets
N/A
Non CTD
N/A
N
Y
Commercialized in
India with Abbott
Healthcare, Alkem
Metformin HCl 500 mg SR +
Gliclazide 60 mg SR Tablets
N/A
Non CTD
N/A
N
Y
Commercialized in
India with Abbott
Healthcare, Alkem,
Micro Lab
Metformin HCl 500 mg SR +
Atorvastatin 10 mg +
Glimepiride 2 mg Tablets
Obimet SR® Metformin HCl SR
Tablets 500 mg (Abbott India Ltd,
India) + Storvas® Atorvastatin 10 mg
Tablets (Ranbaxy, India) + Amaryl®2
Glimepiride Tablets 2 mg
(Aventis, India)
ACTD
Yes
Y
Y
Development
Completed
Metformin HCl 500 mg SR +
Atorvastatin 10 mg +
Glimepiride 1 mg Tablets
Obimet SR® Metformin HCl
SR Tablets 500 mg (Abbott India Ltd,
India) + Storvas® Atorvastatin 10
mg Tablets (Ranbaxy, India) +
Amaryl®2 Glimepiride Tablets 2 mg
(Aventis, India)
ACTD
Yes
Y
Y
Development
Completed
Metformin HCl 500 mg SR +
Atorvastatin 10 mg Tablets
Obimet® SR Metformin HCl SR
Tablets 500 mg (Abbott, India Ltd) +
Storvas® Atorvastatin Tablets 10 mg
(Ranbaxy ,India)
ACTD
Yes
Y
N
Development
Completed
Metformin HCl 500 mg SR +
Glimepiride 2 mg + Voglibose
0.2 mg Tablets
N/A
Non CTD
N/A
IP
Y
Commercialized in
India with Franco,
Merck
Metformin HCl 500 mg SR +
Glimepiride 2 mg + Voglibose
0.3 mg Tablets
N/A
Non CTD
N/A
IP
N
Development
Completed
Metformin HCl 500 mg SR +
Pioglitazone 7.5 mg +
Gliclazide 30 mg SR Tablets
N/A
Non CTD
N/A
IP
Y
Commercialized in
India with Ipca
Metformin HCl 500 mg SR +
Pioglitazone 7.5 mg +
Gliclazide 60 mg SR Tablets
N/A
Non CTD
N/A
IP
Y
Commercialized
in India
with Ipca
Metformin HCl 500 mg SR +
Pioglitazone HCl 15 mg
Tablets
Glucophage® Metformin HCl XR
Tablets 500 mg (BMS, US) +
Actos® Pioglitazone HCl Tablets
30 mg (Takeda, US)
ACTD
N/A
Y
Y
Commercialized in
India with Abbott
Healthcare, Franco
Indian, Sanofi;
ROW markets
Metformin HCl 500 mg SR +
Pioglitazone HCl 30 mg
Tablets
Glucophage® Metformin HCl XR
Tablets 500 mg (BMS, US) +
Actos® Pioglitazone HCl Tablets
30 mg (Takeda, US)
ACTD
N/A
Y
Y
Commercialized
in India with Abbott
Healthcare;
ROW markets
Molecule
Molecule
Metformin HCl 500 mg SR +
Pioglitazone HCl 7.5 mg +
Glimepiride 1 mg Tablets
N/A
Non CTD
N/A
IP
Y
Commercialized in
India with Alkem,
Aristo, Cipla,
Intas, Ipca
Metformin HCl 500 mg SR +
Pioglitazone HCl 7.5 mg +
Glimepiride 2 mg Tablets
N/A
Non CTD
N/A
IP
Y
Commercialized in
India with Alkem,
Aristo, Cipla,
Intas, Ipca
Metformin HCl 500 mg SR +
Voglibose 0.2 mg Tablets
N/A
ACTD
Yes
Y
Y
Commercialized in
India with Merck,
Sanofi
Key: IP: In Progress
Y: Yes
Confidential
N/A : Not Available
N: No
Page 2 of 14
Anti
Anti
Diabetic
Diabetic
Molecule
Molecule
BE Reference Product
Dossier
Type
CT Data
Availability
DCGI
(Y, N,
IP, NA)
Local FDA
(Y/N)
Commercialization
Status
Metformin HCl 500 mg SR +
Voglibose 0.3 mg Tablets
Glycophage® Metformin HCl SR
Tablets 500 mg (BMS, US) +
Volix® Voglibose Tablets 0.3 mg
(Ranbaxy, India)
ACTD
N/A
Y
Y
Commercialized
in India
with Merck, Sanofi
Metformin HCl 500 mg SR +
Fenofibrate 160 mg Tablets
Obimet® Metformin HCl SR Tablets
500 mg (Abbott India Ltd, India)+
Stanlip® Fenofibrate Tablets
160 mg (Ranbaxy, India)
ACTD
N/A
Y
N
Development
Completed
Metformin HCl 500 mg SR +
Glimepiride 1 mg + Voglibose
0.2 mg Tablets
N/A
Non CTD
N/A
IP
Y
Commercialized in
India with Franco,
Merck
Metformin HCl 500 mg SR +
Glimepiride 1 mg + Voglibose
0.3 mg Tablets
N/A
Non CTD
N/A
IP
N
Development
Completed
Metformin HCl 500 mg SR +
Glimipride 1 mg Tablets
Glucophage® Metformin
HCl XR Tablets 500 mg (BMS,US)
+ Amaryl®2 Glimepiride
Tablets 2 mg (Aventis, India)
ACTD
N/A
Y
Y
Commercialized in
India with Franco
Indian, Glaxo,
Merck; ROW
markets
Metformin HCl 500 mg SR +
Glimipride 2 mg Tablets
Glucophage® Metformin HCl XR
Tablets 500 mg (BMS,US) +
Amaryl®2 Glimepiride Tablets
2 mg (Aventis, India)
ACTD
N/A
Y
Y
Commercialized in
with Franco Indian,
Glaxo, Merck;
ROW markets
Metformin HCl 500 mg SR +
Methycobalamin 750 mcg
Tablets
N/A
Non CTD
N/A
N
Y
Commercialized in
India with Aristo
Metformin HCl 500 mg SR +
Methylcobalamin 1500 mcg
Tablets
N/A
Non CTD
N/A
IP
Y
Development
Completed
Metformin HCl 500 mg SR +
Pioglitazone 15 mg +
Gliclazide 60 mg SR Tablets
Piozone M® Pioglitazone 15 mg +
Metformin HCl SR 500 mg Tablets
(Abbott Health Care Ltd , India )+
Diamicron® Gliclazide XR Tablets
60 mg (Serdia, India)
Non CTD
Yes
Y
Y
Commercialized in
India with
Ipca, Micro
Metformin HCl 500 mg SR +
Pioglitazone 15 mg +
Gliclazide 30 mg SR Tablets
Piozone M® Pioglitazone 15 mg +
Metformin HCl SR Tablets 500 mg
(Abbott Health Care Ltd , India ) +
Diamicron® Gliclazide XR
Tablets 60 mg (Serdia, India)
Non CTD
Yes
Y
Y
Commercialized in
India with Ipca,
Micro Lab
Metformin HCl SR 750 mg
Tablets
Glucophage® Metformin
HCl XR Tablets 750 mg
(Merck, UK)
ACTD
N/A
IP
Y
Commercialized in
ROW markets
Pioglitazone 15 mg +
Glimepiride 1 mg Capsules
N/A
Non CTD
N/A
N
Y
Commercialized in
India with Lupin
Pioglitazone 15 mg +
Glimepiride 2 mg Capsules
N/A
Non CTD
N/A
N
Y
Commercialized
in India with Lupin
Pioglitazone 15 mg Tablets
N/A
ACTD
N/A
N/A
N
Commercialized in
ROW markets
Key: IP: In Progress
Y: Yes
Confidential
N/A : Not Available
N: No
Page 3 of 14
Anti
Anti
Diabetic
Diabetic
BE Reference Product
Dossier
Type
CT Data
Availability
DCGI
(Y, N,
IP, NA)
Local FDA
(Y/N)
Commercialization
Status
Pioglitazone 30 mg Tablets
N/A
ACTD
N/A
N/A
N
Commercialized in
ROW markets
Voglibose 0.2 mg ODT
N/A
Non CTD
N/A
N/A
Y
Development
Completed
Voglibose 0.3 mg ODT
N/A
Non CTD
N/A
N/A
Y
Development
Completed
Molecule
Molecule
Key: IP: In Progress
Y: Yes
Confidential
N/A : Not Available
N: No
Page 4 of 14
Gastrointestinal
Molecule
Molecule
BE Reference Product
Dossier
Type
CT Data
Availability
DCGI
(Y, N,
IP, NA)
Local FDA
(Y/N)
Commercialization
Status
Esomeprazole 20 mg EC +
Domperidone 30 mg SR
Capsules
N/A
Non CTD
N/A
Y
Y
Commercialized in
India with Cipla,
Glenmark,
Sun Pharma,
Unichem
Esomeprazole 20 mg
EC Capsules
N/A
Non CTD
N/A
Y
N
Commercialized in
ROW markets
N/A
Non CTD
N/A
Y
Y
Commercialized in
India with Cipla,
Glenmark,
Sun Pharma,
Unichem
Ganaton OD® Itopride
SR Capsules 150 mg
(Abbott India Ltd, India)
+ Nexpro® Esomeprazole
Tablets 40 mg (Torrent, India)
Non CTD
N/A
Y
Y
Development
Completed
Esomeprazole 40 mg
EC Capsules
N/A
Non CTD
N/A
Y
N
Commercialized in
ROW markets
Itopride HCl 150 mg
SR Capsules
Ganaton® Itopride
Tablets 50 mg
(Abbott India Ltd, India)
Non CTD
Yes
Y
Y
Commercialized in
India with
Abbott India
Omeprazole 20 mg +
Domperidone 30 mg
SR Capsules
Omez® Omeprazole Tablets 20 mg
(Dr.Reddy's Lab, India) +
Domstal OD® Domperidone SR
Tablets 30 mg (Torrent, India)
ACTD
N/A
Y
Y
Commercialized in
ROW markets
Ondansetron 4 mg ODT
N/A
Non CTD
N/A
N
Y
Commercialized in
India with
Abbott Healthcare
Ondansetron 8 mg ODT
N/A
Non CTD
N/A
N
Y
Development
Completed
Pantoprazole 40 mg +
Domperidone 30 mg SR
Capsules
Pantocid® Pantoprazole EC
Tablets 40 mg (Sun Pharma,
India) + Domstal® Domperidone
SR Tablets 30 mg (Torrent, India)
ACTD
Yes
Y
Y
Commercialized in
India with Aristo,
FDC Ltd, Franco
Indian, Ipca;
ROW markets
Pantoprazole 40 mg +
Itopride 150 mg SR Capsules
Pantocid® Pantoprazole
EC Tablets 40 mg (Sun Pharma,
India) + Ganaton® Itopride SR
Capsules 150 mg (Abbott, India)
Non CTD
Yes
Y
Y
Commercialized in
India with Abbott
India, Aristo,
Lupin Ltd
N/A
ACTD
N/A
Y
Y
Commercialized in
ROW markets
Veloz 20® Rabeprazole Sodium
Tablets 20 mg (Torrent, India)
+ Ganaton® Itopride Tablets 50 mg
TID ( Abbott India Ltd, India)
Non CTD
N/A
Y
Y
Commercialized in
India with
Cipla, Systopic
Pariet® Rabeprazole
Tablets 20 mg (Eisai, Japan)
ACTD
N/A
Y
N
Commercialized in
ROW markets
Esomeprazole 40 mg EC +
Domperidone 30 mg SR
Capsules
Esomeprazole 40 mg EC +
Itopride 150 mg SR Capsules
Pantoprazole 40 mg
Buffer Tablets
Rabeprazole 20 mg EC +
Itopride 150 mg SR Capsules
Rabeprazole Sodim 10 mg
EC Capsules
Key: IP: In Progress
Y: Yes
Confidential
N/A : Not Available
N: No
Page 5 of 14
Gastrointestinal
Molecule
Molecule
Rabeprazole Sodium 20 mg
Buffer Tablets
BE Reference Product
Dossier
Type
CT Data
Availability
DCGI
(Y, N,
IP, NA)
Local FDA
(Y/N)
Commercialization
Status
Parit® Rabeprazole Tablets 20 mg
(Glaxo SmithKline, India)
ACTD
N/A
Y
Y
Commercialized in
India with Ipca;
ROW markets
Rabeprazole Sodium 20 mg
EC + Domperidone 30 mg
SR Capsules
Domstal OD® Domperidone
Tablets 30 mg (Torrent, India)
+ Pariet® Rabeprazole
Tablets 20 mg (Eisai, Japan)
ACTD
N/A
Y
Y
Commercialized in
India with Cipla,
Dr. Reddy's Lab,
Eisai Pharma,
Emenox Healthcare,
FDC, Jenburkt,
Sun Pharma,
Panacea Biotec;
ROW markets
Rabeprazole Sodium 20 mg
EC Capsules
Pariet® Rabeprazole Tablets 20 mg
(Eisai, Japan)
ACTD
N/A
Y
N
Commercialized in
ROW markets
Key: IP: In Progress
Y: Yes
Confidential
N/A : Not Available
N: No
Page 6 of 14
Cardiovascular
BE Reference Product
Dossier
Type
CT Data
Availability
DCGI
(Y, N,
IP, NA)
Local FDA
(Y/N)
Commercialization
Status
Diltiazem HCl 120 mg
ER Capsules
Tiazac® Diltiazem ER
Capsules 180 mg
(Biovail Pharma, Ontario)
ACTD
N/A
N
Y
Commercialized in
ROW markets
Diltiazem HCl 90 mg
ER Capsules
Tiazac® Diltiazem
ER Capsules 180 mg
(Biovail Pharma, Ontario)
ACTD
N/A
N
Y
Commercialized in
ROW markets
Felodipine 2.5 mg ER Tablets
Plendil® Felodipine ER Tablets
10 mg (AstraZeneca LP,US)
ACTD
N/A
N/A
N
Development
Completed
Felodipine 5 mg ER Tablets
Plendil® Felodipine ER Tablets
10 mg (AstraZeneca LP,US)
ACTD
N/A
N/A
N
Development
Completed
Plendil® Felodipine ER Tablets
10 mg (AstraZeneca LP,US)
ACTD
N/A
N/A
N
Development
Completed
Fenofibrate 145 mg Tablets
Tricor® Fenofibrate
Tablets 145 mg (Abbott, US)
ACTD
N/A
Y
N
Commercialized in
ROW markets
Fenofibrate 160 mg Tablets
N/A
ACTD
N/A
N
N
Commercialized in
ROW markets
Isosorbide Mononitrate 30 mg
SR Capsules
N/A
ACTD
N/A
Y
Y
Commercialized in
India with Ipca;
ROW markets
Isosorbide Mononitrate 60 mg
SR Capsules
N/A
ACTD
N/A
Y
Y
Commercialized in
ROW markets
Metoprolol 25 mg SR +
Telmisartan 40 mg Capsules
N/A
ACTD
N/A
N
N
Development
Completed
Metoprolol 25 mg SR +
Isosorbide Mononitrate 30 mg
SR Capsules
Imdur® Isosorbide Mononitrate
SR Tablets 60 mg (Astrazeneca,
India) + Seloken XL® Metoprolol
Tartarate Tablets 50 mg
(Astrazeneca ,India)
ACTD
N/A
Y
Y
Development
Completed
Metoprolol 25 mg SR +
Isosorbide Mononitrate 60 mg
SR Capsules
Imdur® Isosorbide Mononitrate
SR Tablets 60 mg (Astrazeneca,
India) + Seloken XL® Metoprolol
Tartarate Tablets 50 mg
(Astrazeneca ,India)
ACTD
N/A
Y
Y
Development
Completed
N/A
ACTD
N/A
N
N
Development
Completed
Seloken XL® Metoprolol Tartarate
Tablets 50 mg (Astrazeneca, India) +
Stamlo® Amlodipine Capsules 5 mg
(Dr Reddy's Labs, India)
ACTD
N/A
Y
Y
Development
Completed
Molecule
Molecule
Felodipine 10 mg ER Tablets
Metoprolol 50 mg SR +
Telmisartan 40 mg Capsules
Metoprolol 50 mg SR +
Amlodipine 5 mg Capsules
Key: IP: In Progress
Y: Yes
Confidential
N/A : Not Available
N: No
Page 7 of 14
Cardiovascular
Molecule
Molecule
Metoprolol 50 mg SR +
Isosorbide Mononitrate 30 mg
SR Capsules
BE Reference Product
Dossier
Type
CT Data
Availability
DCGI
(Y, N,
IP, NA)
Local FDA
(Y/N)
Commercialization
Status
Imdur® Isosorbide Mononitrate
SR Tablets 60 mg
(Astrazeneca, India) + Seloken XL®
Metoprolol Tartarate Tablets 50 mg
(Astrazeneca ,India)
ACTD
N/A
Y
Y
Development
Completed
ACTD
N/A
Y
Y
Development
Completed
ACTD
N/A
Y
Y
Commercialized
in ROW markets
Imdur® Isosorbide Mononitrate SR
Metoprolol 50 mg SR +
Tablets 60 mg (Astrazeneca, India) +
Isosorbide Mononitrate 60 mg
Seloken XL® Metoprolol Tartarate
SR Capsules
Tablets 50 mg
(Astrazeneca ,India)
Trimetazidine 60 mg SR
Capsules
Flavedon® Trimetazidine
Tablets 20 mg
(Serdia Pharmaceuticals, India)
Key: IP: In Progress
Y: Yes
Confidential
N/A : Not Available
N: No
Page 8 of 14
Respiratory
Molecule
Molecule
Ambroxol 75 mg SR
Capsules
Levocetirizine Dihydrochloride
5 mg + Ambroxol 75 mg SR
Capsules
Levocetirizine HCl 5 mg
Mouth Dissolving Tablets
BE Reference Product
Dossier
Type
CT Data
Availability
DCGI
(Y, N,
IP, NA)
Local FDA
(Y/N)
Commercialization
Status
Liquidix® Ambroxol SR Tablets
75 mg (Sandoz - Novartis, India)
Non CTD
N/A
Y
Y
Commercialized in
ROW markets
Teczine® Levocetrizine HCl
Tablets 5 mg (Ranbaxy, India Ltd)+
Liquidix SR® Ambroxol
SR Tablets 75 mg
(Sandoz - Novartis,India)
Non CTD
N/A
Y
Y
Commercialized in
India with
Dr. Reddy Lab
N/A
ACTD
N/A
Y
Y
Commercialized in
India with
Ipca, Bayer,
ROW markets
Key: IP: In Progress
Y: Yes
Confidential
N/A : Not Available
N: No
Page 9 of 14
CNS
BE Reference Product
Dossier
Type
CT Data
Availability
DCGI
(Y, N,
IP, NA)
Local FDA
(Y/N)
Commercialization
Status
Oxcarbazepine 150 mg
SR Tablets
Selzic® Oxcarbazepine
Tablets 300 mg BID
(Ranbaxy ,India)
Non CTD
N/A
Y
Y
Development
Completed
Oxcarbazepine 300 mg
SR Tablets
Selzic® Oxcarbazepine
Tablets 300 mg BID
(Ranbaxy ,India)
Non CTD
N/A
Y
Y
Commercialized in
India with
Alkem & Unichem
Oxcarbazepine 600 mg
SR Tablets
Selzic® Oxcarbazepine
Tablets 300 mg BID
(Ranbaxy ,India)
Non CTD
N/A
Y
Y
Commercialized in
India with
Alkem & Unichem
PEG SR® Pregabalin SR Tablets
300 mg (Ipca, India) + Nuroday®
Methylcobalamin Tablets
1500 mcg (Wockhardt, India)
ACTD
N/A
Y
Y
Commercialized in
India with Eris,
Ipca, Lupin;
ROW markets
Lyrica® Pregabalin Capsules
150 mg (Pfizer, Germany)
ACTD
Yes
Y
Y
Commercialized in
India with Eisai,
Ipca, Lupin;
ROW markets
PEG SR® Pregabalin SR Tablets
300 mg (Ipca, India) +
Nuroday® Methylcobalamin
Tablets 1500 mcg (Wockhardt, India)
ACTD
N/A
Y
Y
Development
Completed
Lyrica® Pregabalin Capsules
150 mg (Pfizer, Germany)
ACTD
Yes
Y
Y
Commercialized in
ROW markets
Y
Commercialized in
India with Alkem,
Aristo, Emenox
Healthcare, Eris ,
Ipca,Jenburkt,
Lupin, Sanofi,
Unichem, Viilbery,
Wockhardt,
Zuventus, FDC;
ROW markets
Y
Commercialized in
India with Alkem,
Cipla, Eisai, Ipca,
Lupin, Unichem;
ROW markets
Molecule
Molecule
Pregabalin 150 mg SR +
Methylcobalamin 1500 mcg
Tablets
Pregabalin 150 mg
SR Tablets
Pregabalin 300 mg SR +
Methylcobalamin 1500 mcg
Tablets
Pregabalin 300 mg
SR Tablets
Pregabalin 75 mg SR +
Methylcobalamin 1500 mcg
Tablets
Pregabalin 75 mg SR Tablets
PEG SR® Pregabalin SR Tablets
300 mg (Ipca, India) + Nuroday®
Methylcobalamin Tablets 1500 mcg
(Wockhardt, India)
Lyrica® Pregabalin Capsules
150 mg (Pfizer, Germany)
ACTD
Yes
ACTD
Key: IP: In Progress
Y: Yes
Confidential
N/A
N/A : Not Available
N: No
Page 10 of 14
Y
Y
Pain Management
BE Reference Product
Dossier
Type
CT Data
Availability
DCGI
(Y, N,
IP, NA)
Local FDA
(Y/N)
Commercialization
Status
Aceclofenac 200 mg
SR Capsules
N/A
ACTD
N/A
Y
Y
Commercialized in
ROW markets
Diclofenac Diethylamine
Topical Gel 1.16 % w/w
N/A
Non CTD
Yes
N/A
Y
Development
Completed
Diclofenac Sodium 100 mg
SR + Rabeprazole 20 mg
Capsules
Veloz® Rabeprazole Tablets
20 mg (Torrent, India) + Voveran®
Diclofenac Sodium SR Tablets
100 mg (Novartis, India)
Non CTD
Yes
Y
Y
Commercialized in
India with Abbott
Healthcare
Eperisone 150 mg SR +
Diclofenac Sodium 100 mg
SR Capsules
Epry® Eperisone Tablets
50 mg (Eisai Co., Japan) +
Voveran® Diclofenac Sodium SR
Tablets 100 mg (Novartis, India)
ACTD
Yes
Y
Y
Commercialized in
India with Abbott
Healthcare, Eisai,
Sanofi
Eperisone 150 mg
SR Capsules
Epry® Eperisone Tablets 50 mg
(Eisai Co., Japan)
ACTD
Yes
Y
Y
Commercialized in
India with Abbott
Healthcare, Eisai,
ROW markets
Eperisone 75 mg SR +
Diclofenac Sodium 100 mg
SR Capsules
Epry® Eperisone Tablets 50 mg
(Eisai Co., Japan) + Voveran®
Diclofenac Sodium SR
Tablets 100 mg (Novartis, India)
ACTD
Yes
Y
Y
Commercialized in
India with Eisai
Eperisone 75 mg
SR Capsules
Epry® Eperisone Tablets 50 mg
(Eisai Co., Japan)
ACTD
Yes
Y
Y
Commercialized in
India with Eisai
Pregabalin 150 mg SR +
Aceclofenac 200 mg SR
Tablets
N/A
Non CTD
IP
IP
Y
Commercialized in
India with Ipca;
Pregabalin 75 mg SR +
Aceclofenac 200 mg
SR Tablets
N/A
Non CTD
IP
IP
Y
Commercialized in
India with Ipca
Altraflam® Aceclofenac SR
Capsules 200 mg (Ranbaxy, India)
+ Roles® Rabeprazole EC
Tablets 20 mg (Ranbaxy, India)
ACTD
Yes
Y
Y
Commercialized in
India with Jenburkt,
Sun Pharma,
ROW markets
Tapentadol 100 mg
SR Tablets
Tapenta® Tapentadol Tablets
100 mg (Zuventus, India)
Non CTD
N/A
Y
N
Development
Completed
Tapentadol 200 mg
SR Tablets
Tapenta® Tapentadol Tablets
100 mg (Zuventus, India)
Non CTD
N/A
Y
N
Development
Completed
Tapentadol 50 mg
SR Tablets
Tapenta® Tapentadol Tablets
100 mg (Zuventus, India)
Non CTD
N/A
Y
N
Development
Completed
Molecule
Molecule
Rabeprazole 20 mg EC +
Aceclofenac 200 mg
SR Capsules
Key: IP: In Progress
Y: Yes
Confidential
N/A : Not Available
N: No
Page 11 of 14
Pain Management
BE Reference Product
Dossier
Type
CT Data
Availability
DCGI
(Y, N,
IP, NA)
Local FDA
(Y/N)
Commercialization
Status
Myoril® Thiocolchicoside Capsules
8 mg (Sanofi Aventis, India) +
Voveran® Diclofenac Sodium SR
Tablets 100 mg (Novartis, India)
Non CTD
Yes
Y
N
Development
Completed
Myoril® Thiocolchicoside
Capsules 8 mg (Sanofi Aventis,
India) + Zerodol® Aceclofenac
Tablets 100 mg (Ipca, India)
ACTD
Yes
Y
Y
Commercialized in
India with Aristo,
Cadila Pharma,
Ipca, Wallace
Myoril® Thiocolchicoside
Capsules 8 mg
(Sanofi Aventis, India)
ACTD
N/A
Y
N
Development
Completed
Thiocochicoside 8 mg SR +
Diclofenac Sodium 100 mg
SR Capsules
Myoril® Thiocolchicoside Capsules
8 mg (Sanofi Aventis, India) +
Voveran® Diclofenac Sodium
SR Tablets 100 mg (Novartis, India)
Non CTD
Yes
IP
N
Development
Completed
Thiocochicoside 8 mg SR +
Aceclofenac 200 mg
SR Capsules
Myoril® Thiocolchicoside Capsules
8 mg (Sanofi Aventis, India)
+ Zerodol® Aceclofenac
Tablets 100 mg (Ipca, India)
ACTD
Yes
Y
Y
Commercialized in
India with Aristo,
Cadila Pharma,
FDC, Innovcare,
Ipca, Jenburkt,
Panacea Wallace
Myoril® Thiocolchicoside
Capsules 8 mg
(Sanofi Aventis, India)
ACTD
N/A
Y
N
Development
Completed
Tolperisone 450 mg SR +
Diclofenac Sodium 100 mg
SR Tablets
Voveran® Diclofenac Sodium SR
Tablets 100 mg (Novartis, India) +
Tolfree® Tolperisone HCl Tablets
150 mg (Zydus Cadila, India)
Non CTD
Yes
Y
Y
Commercialized in
India with
Unichem, Zuventus
Tolperisone 450 mg
SR Tablets
Tolfree® Tolperisone HCl Tablets
150 mg (Zydus Cadila, India)
Non CTD
N/A
IP
N
Development
Completed
Molecule
Molecule
Thiocochicoside 16 mg
SR + Diclofenac Sodium
100 mg Capsules
Thiocochicoside 16 mg SR
+ Aceclofenac 200 mg
SR Capsules
Thiocochicoside 16 mg
SR Capsules
Thiocochicoside 8 mg
SR Capsules
Key: IP: In Progress
Y: Yes
Confidential
N/A : Not Available
N: No
Page 12 of 14
Urinogenital
CT Data
Availability
DCGI
(Y, N,
IP, NA)
Local FDA
(Y/N)
Commercialization
Status
N/A
IP
N
Development
Completed
ACTD
N/A
IP
N
Development
Completed
Viagra® Sildenafil Tablets
50 mg (Pfizer Labs, France)
ACTD
N/A
N/A
N
Commercialized in
ROW markets
Tamsulosin 0.2 mg
SR Capsules
N/A
Non CTD
N/A
N
N
Commercialized in
ROW markets
Tamsulosin 0.4 mg
SR Capsules
N/A
Non CTD
N/A
N
N
Commercialized in
ROW markets
BE Reference Product
Dossier
Type
Dapoxetine 30 mg
Mouth Dissolving Tablets
Duralast® Dapoxetine Tablets
60 mg (Sun Pharma, India)
ACTD
Dapoxetine 60 mg
Mouth Dissolving Tablets
Duralast® Dapoxetine Tablets
60 mg (Sun Pharma, India)
Sidenafil 50 mg
Orodispersible Tablets
Molecule
Molecule
Key: IP: In Progress
Y: Yes
Confidential
N/A : Not Available
N: No
Page 13 of 14
Anti Infective
BE Reference Product
Dossier
Type
CT Data
Availability
DCGI
(Y, N,
IP, NA)
Local FDA
(Y/N)
Commercialization
Status
Azithromycin 250 mg Tablets
N/A
Non CTD
N/A
N/A
N
Commercialized in
ROW markets
Azithromycin 500 mg Tablets
N/A
Non CTD
N/A
N/A
N
Commercialized in
ROW markets
Linezolid 1200 mg SR Tablets
Lizolid® Linezolid Tablets 600 mg
(Glenmark, India)
Non CTD
Yes
IP
Y
Commercialized in
India with Zuventus,
IPCA, Unichem
Molecule
Molecule
Key: IP: In Progress
Y: Yes
Confidential
N/A : Not Available
N: No
Page 14 of 14