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

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$ API Ref.Price (USD/KG) : 3,449Xls
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01 1Minakem

02 1Coral Drugs Private Limited

03 2Axplora

04 1Aspen API

05 1Aarti Pharmalabs

06 1Hubei Gedian Humanwell Pharmaceutical

07 1Amphastar Pharmaceuticals

08 1Apotex Pharmachem

09 1AstraZeneca

10 2Breathgreen Pharmaceuticals

11 1Cipla

12 2Curia

13 1Henan Lihua Pharmaceutical

14 2Industriale Chimica

15 1NEWCHEM SPA

16 1Sterling Spa

17 1Sun Pharmaceutical Industries Limited

18 2Teva API

19 1Tianjin Tianyao Pharmaceuticals Co., Ltd.

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMinakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

GDUFA

DMF Review : Complete

Rev. Date : 2017-03-03

Pay. Date : 2017-02-10

DMF Number : 28441

Submission : 2014-06-20

Status : Active

Type : II

Minakem Comapny Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCoral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 30534

Submission : 2017-02-02

Status : Active

Type : II

Corel Drugs cGMP partner for APIs

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAxplora- The partner of choice for complex APIs.

GDUFA

DMF Review : Complete

Rev. Date : 2013-05-16

Pay. Date : 2013-05-03

DMF Number : 18910

Submission : 2005-10-26

Status : Active

Type : II

Axplora CB

04

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 10493

Submission : 1993-09-23

Status : Active

Type : II

Aspen API Comapny Banner

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

GDUFA

DMF Review : Complete

Rev. Date : 2014-04-03

Pay. Date : 2013-03-04

DMF Number : 20609

Submission : 2007-06-13

Status : Active

Type : II

Aarti Industries Company Banner

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.

GDUFA

DMF Review : Complete

Rev. Date : 2022-08-03

Pay. Date : 2022-04-21

DMF Number : 34268

Submission : 2019-10-29

Status : Active

Type : II

Hubei Gedian Humanwell Pharmaceutical

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAxplora- The partner of choice for complex APIs.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 25615

Submission : 2011-12-20

Status : Active

Type : II

Axplora CB