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

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$ API Ref.Price (USD/KG) : 362Xls
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01 1Aspen API

02 1Medichem S.A

03 2Megafine Pharma (P) Limited

04 3Neuland Laboratories

05 1Angelini Pharma

06 1Aurobindo Pharma Limited

07 1Fujifilm Diosynth Biotechnologies

08 1Hetero Drugs

09 2Maithri Drugs

10 1Micro Labs Limited

11 1Sumitomo Chemical

12 1Sun Pharmaceutical Industries Limited

13 1Syn-Tech Chem. & Pharm

14 1Teva API

15 2Viatris

16 1Zhejiang Liaoyuan Pharmaceutical Co LTD

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PharmaCompass

01

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 10457

Submission : 1993-08-30

Status : Active

Type : II

Aspen API Comapny Banner

02

  • fda
  • EDQM
  • WHO-GMP

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

GDUFA

DMF Review : Complete

Rev. Date : 2013-04-30

Pay. Date : 2013-04-17

DMF Number : 15749

Submission : 2001-12-05

Status : Active

Type : II

Medichem

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 20570

Submission : 2007-05-28

Status : Active

Type : II

Megafine Pharma

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 16007

Submission : 2002-06-11

Status : Active

Type : II

Neuland

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

GDUFA

DMF Review : Complete

Rev. Date : 2013-10-07

Pay. Date : 2013-09-26

DMF Number : 23003

Submission : 2009-07-30

Status : Active

Type : II

Megafine Pharma

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

GDUFA

DMF Review : Complete

Rev. Date : 2023-12-28

Pay. Date : 2023-11-24

DMF Number : 30850

Submission : 2016-09-07

Status : Active

Type : II

Neuland

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 24022

Submission : 2010-08-04

Status : Active

Type : II

Neuland