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

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$ API Ref.Price (USD/KG) : 17,057Xls
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01 1Nuray Chemicals Private Limited

02 1Biophore India Pharmaceuticals Pvt Ltd

03 1Aurobindo Pharma Limited

04 1Enaltec Labs Private Limited

05 1MSN Laboratories

06 1Teva API

07 1Zhejiang Ausun Pharmaceutical

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.

GDUFA

DMF Review : Complete

Rev. Date : 2018-07-27

Pay. Date : 2018-06-04

DMF Number : 32444

Submission : 2018-06-06

Status : Active

Type : II

Nuray Chemicals

02

  • 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 : 2020-11-12

Pay. Date : 2020-09-24

DMF Number : 34414

Submission : 2019-12-31

Status : Active

Type : II

Biophore

04

AAPS 2024
Not Confirmed

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