01 1PharmaZell
02 1New Zealand Pharmaceuticals Ltd
03 2SAFC
04 1SIGMA TAU
GDUFA
DMF Review : Complete
Rev. Date : 2025-06-20
Pay. Date : 2025-05-01
DMF Number : 41790
Submission : 2025-05-23
Status :
Type : II
48
PharmaCompass offers a list of Cholic 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 Cholic Acid manufacturer or Cholic Acid supplier for your needs.
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A 3a,7a,12a-Trihydroxy-beta-cholanate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 3a,7a,12a-Trihydroxy-beta-cholanate, including repackagers and relabelers. The FDA regulates 3a,7a,12a-Trihydroxy-beta-cholanate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 3a,7a,12a-Trihydroxy-beta-cholanate 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 3a,7a,12a-Trihydroxy-beta-cholanate supplier is an individual or a company that provides 3a,7a,12a-Trihydroxy-beta-cholanate active pharmaceutical ingredient (API) or 3a,7a,12a-Trihydroxy-beta-cholanate finished formulations upon request. The 3a,7a,12a-Trihydroxy-beta-cholanate suppliers may include 3a,7a,12a-Trihydroxy-beta-cholanate API manufacturers, exporters, distributors and traders.
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A 3a,7a,12a-Trihydroxy-beta-cholanate DMF (Drug Master File) is a document detailing the whole manufacturing process of 3a,7a,12a-Trihydroxy-beta-cholanate active pharmaceutical ingredient (API) in detail. Different forms of 3a,7a,12a-Trihydroxy-beta-cholanate DMFs exist exist since differing nations have different regulations, such as 3a,7a,12a-Trihydroxy-beta-cholanate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 3a,7a,12a-Trihydroxy-beta-cholanate DMF submitted to regulatory agencies in the US is known as a USDMF. 3a,7a,12a-Trihydroxy-beta-cholanate USDMF includes data on 3a,7a,12a-Trihydroxy-beta-cholanate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 3a,7a,12a-Trihydroxy-beta-cholanate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 3a,7a,12a-Trihydroxy-beta-cholanate suppliers with USDMF on PharmaCompass.
We have 4 companies offering 3a,7a,12a-Trihydroxy-beta-cholanate
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