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

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$ API Ref.Price (USD/KG) : 591,988Xls
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01 1Biophore India Pharmaceuticals Pvt Ltd

02 1Bachem AG

03 1USV Private Limited

04 1Alembic Pharmaceuticals Limited

05 1AmbioPharm

06 1Auro Peptides Limited

07 1BCN Peptides

08 1Chengdu Shengnuo Biopharm

09 1Cipla

10 1Fresenius Kabi AB Brunna

11 1Hansoh Pharma

12 1MSN Laboratories

13 1Sun Pharmaceutical Industries Limited

14 1Teva API

15 1Viatris

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

GDUFA

DMF Review : Complete

Rev. Date : 2016-12-21

Pay. Date : 2016-09-27

DMF Number : 30526

Submission : 2016-09-27

Status : Active

Type : II

Biophore

02

  • 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 : N/A

Rev. Date :

Pay. Date :

DMF Number : 20862

Submission : 2007-09-17

Status : Active

Type : II

Bachem company banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothUSV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.

GDUFA

DMF Review : Complete

Rev. Date : 2019-02-08

Pay. Date : 2018-12-03

DMF Number : 33212

Submission : 2018-12-07

Status : Active

Type : II

USV Private Limited

04

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Not Confirmed

05

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06

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06

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Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2015-06-30

Pay. Date : 2015-03-30

DMF Number : 28496

Submission : 2015-03-09

Status : Active

Type : II

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10

Formnext Forum
Not Confirmed

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