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List of Drug Master Files (DMF) of Enalapril Maleate Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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$ API Ref.Price (USD/KG) : 194Xls
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01 1Medichem S.A

02 2Neuland Laboratories

03 1Farmhispania

04 1Apotex Pharmachem

05 1ChemSource

06 1Esteve Quimica

07 1Gedeon Richter

08 2Krka

09 1Lek Pharmaceuticals

10 2Maprimed

11 1Merck & Co

12 1RANBAXY LABORATORIES LIMITED

13 1Wockhardt

14 1Zhejiang Huahai Pharmaceutical

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 13055

Submission : 1998-06-29

Status : Active

Type : II

Medichem

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 15434

Submission : 2001-05-15

Status : Active

Type : II

Neuland

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothFarmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 11525

Submission : 1995-05-19

Status : Active

Type : II

Farmhispania

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

GDUFA

DMF Review : Complete

Rev. Date : 2016-06-28

Pay. Date : 2016-06-16

DMF Number : 19984

Submission : 2006-11-17

Status : Active

Type : II

Neuland

05

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Not Confirmed

07

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Not Confirmed

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