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List of Drug Master Files (DMF) of Prestwick3_000931 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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$ API Ref.Price (USD/KG) : 309Xls
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01 1Bachem AG

02 1Neuland Laboratories

03 1Abbott Laboratories

04 1Archimica

05 1AstraZeneca

06 1Curia

07 1Emcure Pharmaceuticals

08 1F.I.S. Fabbrica Italiana Sintetici

09 1Harman Finochem

10 1NOVADEL

11 1SI Group

12 1Unimark Remedies Limited

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.

GDUFA

DMF Review : Complete

Rev. Date : 2013-03-14

Pay. Date : 2012-12-18

DMF Number : 11204

Submission : 1994-11-22

Status : Active

Type : II

Bachem company banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 27418

Submission : 2013-08-13

Status : Active

Type : II

Neuland

06

AAPS 2024
Not Confirmed

09

Novadel Pharma Inc

U.S.A

USDMF

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AAPS 2024
Not Confirmed

09

AAPS 2024
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 17850

Submission : 2004-11-22

Status : Inactive

Type : II

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10

AAPS 2024
Not Confirmed

10

AAPS 2024
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2014-08-20

Pay. Date : 2013-01-09

DMF Number : 11777

Submission : 1995-12-08

Status : Active

Type : II

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