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

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$ API Ref.Price (USD/KG) : 680,068Xls
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01 1Seqens

02 1Dr. Reddy\'s Laboratories

03 1Neuland Laboratories

04 1USV Private Limited

05 1ALP Pharm

06 1Aurobindo Pharma Limited

07 2Catalent Pharma Solutions

08 1Cipla

09 1Emcure Pharmaceuticals

10 1Glenmark Pharmaceuticals

11 1Helsinn Advanced Synthesis

12 1Kyongbo Pharmaceutical Co., Ltd

13 1Lianyungang Runzhong Pharmaceutical Co Ltd

14 1MSN Laboratories

15 1Qilu Pharmaceutical

16 1RANBAXY LABORATORIES LIMITED

17 1Rolabo Outsourcing

18 2Teva API

19 1Tyche Industries Ltd

20 1Wockhardt

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSeqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

GDUFA

DMF Review : Complete

Rev. Date : 2013-07-08

Pay. Date : 2013-01-16

DMF Number : 24798

Submission : 2011-03-23

Status : Active

Type : II

Seqens Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 23590

Submission : 2010-03-01

Status : Active

Type : II

Dr Reddy Company Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 21123

Submission : 2007-12-11

Status : Active

Type : II

Neuland

04

  • 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 : 2015-12-17

Pay. Date : 2015-09-28

DMF Number : 28088

Submission : 2015-09-29

Status : Active

Type : II

USV Private Limited

08

Formnext Forum
Not Confirmed

08

Formnext Forum
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2014-05-20

Pay. Date : 2014-03-10

DMF Number : 24497

Submission : 2010-12-23

Status : Active

Type : II

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