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01 1Amsa Spa

02 1Archimica

03 3AstraZeneca

04 1COSMA S.p.A

05 1Erregierre SpA

06 2Ipca Laboratories

07 1J.B.Chemicals & Pharmaceuticals

08 2Kopran

09 1Recordati

10 1SIMS Srl

11 1SINTENOVO, S.A. DE C.V.

12 1Shanghai Ziyuan Pharmaceutical

13 1Syn-Tech Chem. & Pharm

14 1TAPI Technology & API Services

15 1Viatris

16 1Wanbury Limited

17 1Zydus Lifesciences

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GDUFA

DMF Review : Complete

Rev. Date : 2016-06-14

Pay. Date : 2016-03-21

DMF Number : 24024

Submission : 2010-08-10

Status : Active

Type : II

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Sibefat Spa

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Sibefat Spa

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GDUFA

DMF Review : N/A

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DMF Number : 6921

Submission : 1987-04-10

Status : Inactive

Type : II

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