F.No.
DCGI/MISC/2018/34
Preliminary List of Products Permitted by DCG(I) and considered as Reference Product
for BA/BE Studies (2014-2011)
YEAR 2014
1 Alogliptin Tablet Film Coated 6.25 mg/ 12.5 mg/ 25 M/s. Takeda
Tablet mg Pharmaceutical
India Pvt. Ltd
2 M/s. Biogen Idec
Delayed Biotech India Pvt
Dimethyl Fumarate Release 120 mg/240 mg Ltd.
Capsule
M/s Intas Pharma
3 M/s. Takeda
Pharmaceutical
India Pvt. Ltd
Roflumilast Tablet 500 mcg
M/s Intas Pharma
M/s Cipla Ltd.
4 Regorafenib Tablet 40mg M/s. Bayer
Pharmaceuticals
Pvt. Ltd.
5 Tulobuterol Transdermal 0.5 mg/1.0 mg/2.0 mg M/s. Sparsh
patch Pharmaceuticals
Ltd.
6 Axitinib Tablet 1mg/5mg Pfizer products
India Pvt ltd.
7 Canagliflozin M/s Johnson &
Johnson
Tablet 100mg/300mg
M/s MSN
Laboratories
8 Afatinib Tablet 20 mg/30 mg/40 mg M/s
BoehingerIngelheim
F.No. DCGI/MISC/2018/34
- 50 mg M/s
BoehingerIngelheim
9 Nevirapine M/s Cipla Ltd.
ER Tablet 400 mg M/s Emcure
Pharmaceuticals
limited
10 Indacaterol Capsule 150mcg/300mcg M/s Cipla Ltd.
YEAR 2013
M/s Novartis
1 Ruxolitinib Tablet 5mg/10 mg/15mg/20 mg
Healthcare Pvt. Ltd.
M/s Intervet India
2 Cefalonium Suspension
250 mg/3G Pvt. Ltd.
Film Coated M/s Glenmark
3 GarenoxacinMesylate 250 mg/3G
Tablet Generics Ltd.
M/s Cadila
Healthcare Limited
4 Sarogliazar Tablet 2 mg/ 4 mg
YEAR 2012
M/s Precise
ChemipharmaPvt.
Ltd.
M/s Sun
1 Agomelatine Tablet 25 mg
Pharmaceuticals
Industries Ltd.
M/s MSN
Laboratories Ltd
M/s. MSN
Tablets
2 Tolvaptan 15 mg/30 mg Laboratories Ltd.
M/s.Cadila
F.No. DCGI/MISC/2018/34
Healthcare Ltd
M/s. Huve Pharma
Tablets & 625 mg tablet,
M/s Ind-Swift Labs
3 ColesevelamHCl Sachets for oral Sachet..3.75 gm/ 1.875
Ltd.
suspension gm
M/s Bristol-Myers
Film Coated
2.5 mg Squibb India Pvt.
4 Apixaban Tablet
Ltd.
- 2.5 mg/5 mg M/s. Pfizer
M/s Zuventus
5 Seratrodast Tablet 40 mg/80 mg
Healthcare Ltd.
M/s Cadila
Healthcare Limited
M/s Intas
6 Choline Fenofibrate DR capsules 45 mg/135 mg Pharmaceuticals
Ltd.
M/s Lupin Ltd.
M/s Roche
Film Coated
7 Vemurafenib 240 mg Scientific Company
Tablet
Pvt. Ltd.
Film Coated M/s MSN
8 Almotriptan 6.25 mg/12.5 mg
Tablets Laboratories Ltd.
YEAR 2011
1 Oxaceprol Capsule 200 mg M/s Lupin Limited
200 mg/400 mg/600 M/s Torrent
2 Eslicarbazepine Acetate Tablet mg/800 mg Pharmaceuticals
Ltd.
M/s. Akums Drugs
& Pharmaceuticals
F.No. DCGI/MISC/2018/34
Ltd.
M/s. Psyco
Remedies
M/s. Raven Bhel
Healthcare Pvt .ltd.
M/s Sun
Pharmaceuticals
Industries Ltd.
M/s Sun
Pharmaceuticals
Industries Ltd.
M/s. MSN
Laboratories
M/s. Cadila
Healthcare Ltd
1 mg/2 mg/4 mg/ 6
3 Iloperidone Tablet M/s. Naprod life
mg/8 mg/10 mg/12 mg
science
Pvt.ltd.
M/s. Hetero Labs
Ltd.
M/s. Lupin Ltd.
M/s.Cadila
Healthcare
2 mg/4 mg/8 mg M/s Ajanta Pharma
Tablet
Ltd.
4 Silodosin
4 mg/8 mg M/s MSN
Capsule
Laboratories
250 mg M/s Johnson &
Tablet
5 Abiraterone Acetate Johnson Ltd.
20 mg M/s.Cipla Ltd.
F.No. DCGI/MISC/2018/34
250 mg M/s. BDR
Pharmaceuticals Pvt
Ltd
500 mg Dr. Reddy's
Laboratories
100 mg/200 mg M/s Cadila
6 Revaprazan Tablet
Healthcare Ltd.
M/s Cadila
7 Acrivastine Capsule 8 mg
Healthcare Ltd.
M/s Emcure
10 mg Pharmaceuticals
Ltd.
8 Rivaroxaban Tablet
M/s Torrent
15 mg/20 mg Pharmaceuticals
Limited.
M/s GSK
150 mg/300 mg Pharmaceuticals
Tablet
9 Maraviroc Ltd.
M/s. Hetero Labs
-
Ltd.,
M/s Intas
10 EletriptanHydrobromide Tablet Pharmaceuticals
20 mg/40 mg Ltd.
M/s Cadila
11 Udenafil Tablet
100 mg/200 mg Healthcare Ltd.
Hard gelatin
12 Crizotinib 200 mg/250 mg M/s Pfizer pharma
capsule
Diclofenac M/s Novartis India
13 Capsule 75 mg
Colestyramine Ltd.
M/s Intas
1 TiaprideHCl Tablet 25 mg/50 mg/100 mg Pharmaceuticals
Ltd.
F.No. DCGI/MISC/2018/34
M/s Macleods
Pharmaceutical Ltd.
M/s HeteroLabs
Ltd.
M/s Precise
Biopharma Ltd.
M/s.Inventia
Healthcare Pvt Ltd.
M/s. MSN
Laboratories Ltd
M/s.Synokem
Pharmaceuticals Ltd
M/s. Biodeal
Pharmaceuticals
15 TapentadolHCl Tablet 50 mg/75 mg/100 mg
Pvt. Ltd
M/s. Ind-Swift Ltd
M/s. Acme
Formulations Pvt
Ltd
M/s. Theon
Pharmaceuticals Ltd
M/s. Cadila
Healthcare Ltd
M/s. Akums Drugs
&Pharmaceuticasl
ltd
M/s. Gena
Pharmaceuticals Ltd
M/s Lupin Limited
16 Ilaprazole Tablet 5 mg/10 mg
M/s Ajanta Pharma
F.No. DCGI/MISC/2018/34
Ltd.
M/s. Precise
Chemipharpma Pvt
Ltd
M/s Sun
Pharmaceuticals
Industries Ltd.
M/s. Intas
Pharmaceuticals
Sublingual M/s. MSN Lab. Ltd.
17 Asenapine Malate 5mg/ 10 mg
Tablet M/s. Precise
Chemipharma
M/s.Cadila
Healthcare Limited
M/s.Alkem
Laboratories Ltd.
