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.