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01 1Arene Lifesciences

02 1Aurobindo Pharma Limited

03 1Chongqing Carelife Pharmaceutical

04 1Chromo Laboratories

05 3Cipla

06 1Emcure Pharmaceuticals

07 2Hetero Drugs

08 3Laurus Labs

09 1Lek Pharmaceuticals

10 2Lupin Ltd

11 2MSN Laboratories

12 1Macleods Pharmaceuticals Limited

13 1Micro Labs Limited

14 1Shanghai Desano Chemical Pharmaceutical Co., Ltd.

15 1Styrax

16 2Viatris

17 1Viyash Life Sciences

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PharmaCompass

01

Pharmtech & Ingredients
Not Confirmed

02

Pharmtech & Ingredients
Not Confirmed

03

Pharmtech & Ingredients
Not Confirmed

03

Pharmtech & Ingredients
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2016-07-19

Pay. Date : 2016-05-16

DMF Number : 30055

Submission : 2016-03-17

Status : Active

Type : II

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04

Pharmtech & Ingredients
Not Confirmed

05

Pharmtech & Ingredients
Not Confirmed

06

Pharmtech & Ingredients
Not Confirmed

07

Pharmtech & Ingredients
Not Confirmed

08

Pharmtech & Ingredients
Not Confirmed

09

Pharmtech & Ingredients
Not Confirmed

10

Pharmtech & Ingredients
Not Confirmed