Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1ALP Pharm
03 1BCN Peptides
04 1Chinese Peptide Company
05 1CordenPharma
06 1Hybio Pharmaceutical
07 1Jiangsu Sinopep Allsino Biopharmaceutical
08 1Piramal Pharma Solutions
09 1Sun Pharmaceutical Industries Limited
10 1Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2020-09-24
Pay. Date : 2019-12-12
DMF Number : 34752
Submission : 2020-05-03
Status :
Type : II
A Cetrorelix manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cetrorelix, including repackagers and relabelers. The FDA regulates Cetrorelix manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cetrorelix 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 Cetrorelix manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cetrorelix supplier is an individual or a company that provides Cetrorelix active pharmaceutical ingredient (API) or Cetrorelix finished formulations upon request. The Cetrorelix suppliers may include Cetrorelix API manufacturers, exporters, distributors and traders.
click here to find a list of Cetrorelix suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cetrorelix DMF (Drug Master File) is a document detailing the whole manufacturing process of Cetrorelix active pharmaceutical ingredient (API) in detail. Different forms of Cetrorelix DMFs exist exist since differing nations have different regulations, such as Cetrorelix USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cetrorelix DMF submitted to regulatory agencies in the US is known as a USDMF. Cetrorelix USDMF includes data on Cetrorelix's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cetrorelix USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cetrorelix suppliers with USDMF on PharmaCompass.
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