Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Alembic Pharmaceuticals Limited
03 1BrightGene Bio-Medical Technology Co.,Ltd
04 1Changzhou Pharmaceutical Factory
05 1Hetero Drugs
06 1Industriale Chimica
07 1Kaifeng Pharmaceutical Group Co., Ltd
08 1MSN Laboratories
09 1Optimus Pharma
10 1Solara Active Pharma Sciences
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2020-02-10
Pay. Date : 2019-12-30
DMF Number : 34413
Submission : 2019-12-27
Status :
Type : II
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PharmaCompass offers a list of Obeticholic Acid API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Obeticholic Acid manufacturer or Obeticholic Acid supplier for your needs.
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A 6alpha-ethyl-3alpha,7alpha-dihydroxy-5beta-cholan-24-oic acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 6alpha-ethyl-3alpha,7alpha-dihydroxy-5beta-cholan-24-oic acid, including repackagers and relabelers. The FDA regulates 6alpha-ethyl-3alpha,7alpha-dihydroxy-5beta-cholan-24-oic acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 6alpha-ethyl-3alpha,7alpha-dihydroxy-5beta-cholan-24-oic acid 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 6alpha-ethyl-3alpha,7alpha-dihydroxy-5beta-cholan-24-oic acid supplier is an individual or a company that provides 6alpha-ethyl-3alpha,7alpha-dihydroxy-5beta-cholan-24-oic acid active pharmaceutical ingredient (API) or 6alpha-ethyl-3alpha,7alpha-dihydroxy-5beta-cholan-24-oic acid finished formulations upon request. The 6alpha-ethyl-3alpha,7alpha-dihydroxy-5beta-cholan-24-oic acid suppliers may include 6alpha-ethyl-3alpha,7alpha-dihydroxy-5beta-cholan-24-oic acid API manufacturers, exporters, distributors and traders.
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A 6alpha-ethyl-3alpha,7alpha-dihydroxy-5beta-cholan-24-oic acid DMF (Drug Master File) is a document detailing the whole manufacturing process of 6alpha-ethyl-3alpha,7alpha-dihydroxy-5beta-cholan-24-oic acid active pharmaceutical ingredient (API) in detail. Different forms of 6alpha-ethyl-3alpha,7alpha-dihydroxy-5beta-cholan-24-oic acid DMFs exist exist since differing nations have different regulations, such as 6alpha-ethyl-3alpha,7alpha-dihydroxy-5beta-cholan-24-oic acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 6alpha-ethyl-3alpha,7alpha-dihydroxy-5beta-cholan-24-oic acid DMF submitted to regulatory agencies in the US is known as a USDMF. 6alpha-ethyl-3alpha,7alpha-dihydroxy-5beta-cholan-24-oic acid USDMF includes data on 6alpha-ethyl-3alpha,7alpha-dihydroxy-5beta-cholan-24-oic acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 6alpha-ethyl-3alpha,7alpha-dihydroxy-5beta-cholan-24-oic acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
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We have 10 companies offering 6alpha-ethyl-3alpha,7alpha-dihydroxy-5beta-cholan-24-oic acid
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