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01 1Apotex Pharmachem

02 1Arevipharma

03 1Aurobindo Pharma Limited

04 1Bioindustria L.I.M. Spa

05 2COSMA S.p.A

06 1Cambrex Corporation

07 1Cipla

08 1Hetero Drugs

09 1Ipca Laboratories

10 2JARI Pharmaceutical

11 1Kalintis Healthcare

12 1Medilux Laboratories

13 2Micro Labs Limited

14 1Roche Diagnostics GmbH

15 2Teva API

16 1ZHEJIANG DONGDONG PHARMACEUTICAL

17 1Zhejiang Huahai Pharmaceutical

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PharmaCompass

03

American Pharma Summit
Not Confirmed

04

American Pharma Summit
Not Confirmed

05

American Pharma Summit
Not Confirmed

06

American Pharma Summit
Not Confirmed

06

American Pharma Summit
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2018-01-19

Pay. Date : 2017-12-21

DMF Number : 18360

Submission : 2007-06-26

Status : Active

Type : II

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09

American Pharma Summit
Not Confirmed

10

American Pharma Summit
Not Confirmed