Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1ACIC Europe API & Pharmaceuticals
03 1Cyclo Industries
04 1Industriale Chimica
05 1Raks Pharma
06 1Trifarma
07 1Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2020-10-27
Pay. Date : 2020-09-21
DMF Number : 31842
Submission : 2017-09-25
Status :
Type : II
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A DSSTox_CID_28941 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DSSTox_CID_28941, including repackagers and relabelers. The FDA regulates DSSTox_CID_28941 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DSSTox_CID_28941 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A DSSTox_CID_28941 supplier is an individual or a company that provides DSSTox_CID_28941 active pharmaceutical ingredient (API) or DSSTox_CID_28941 finished formulations upon request. The DSSTox_CID_28941 suppliers may include DSSTox_CID_28941 API manufacturers, exporters, distributors and traders.
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A DSSTox_CID_28941 DMF (Drug Master File) is a document detailing the whole manufacturing process of DSSTox_CID_28941 active pharmaceutical ingredient (API) in detail. Different forms of DSSTox_CID_28941 DMFs exist exist since differing nations have different regulations, such as DSSTox_CID_28941 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A DSSTox_CID_28941 DMF submitted to regulatory agencies in the US is known as a USDMF. DSSTox_CID_28941 USDMF includes data on DSSTox_CID_28941's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DSSTox_CID_28941 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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