Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Evonik
03 1Metrochem API Private Limited
04 1Nuray Chemicals Private Limited
05 3Ajinomoto Company
06 1BD BIOSCIENCES ADVANCED BIOPROCESSING
07 1Emmaus Life Sciences
08 2Irvine Scientific Sales Company
09 1Katayama Seiyakusyo
10 1Kyowa Hakko Bio
11 1Mitsubishi Tanabe Pharma
12 26SAFC
13 1Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37695
Submission : 2022-12-01
Status :
Type : II
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9486
Submission : 1992-01-03
Status :
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38992
Submission : 2023-12-28
Status :
Type : II
Nuray 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 : 2021-10-22
Pay. Date : 2021-08-25
DMF Number : 36082
Submission : 2021-08-26
Status :
Type : II
A Glutamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Glutamine, including repackagers and relabelers. The FDA regulates Glutamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Glutamine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Glutamine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Glutamine supplier is an individual or a company that provides Glutamine active pharmaceutical ingredient (API) or Glutamine finished formulations upon request. The Glutamine suppliers may include Glutamine API manufacturers, exporters, distributors and traders.
click here to find a list of Glutamine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Glutamine DMF (Drug Master File) is a document detailing the whole manufacturing process of Glutamine active pharmaceutical ingredient (API) in detail. Different forms of Glutamine DMFs exist exist since differing nations have different regulations, such as Glutamine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Glutamine DMF submitted to regulatory agencies in the US is known as a USDMF. Glutamine USDMF includes data on Glutamine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Glutamine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Glutamine suppliers with USDMF on PharmaCompass.
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