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-5b-cholanic acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 3a,7a,12a-Trihydroxy-5b-cholanic acid, including repackagers and relabelers. The FDA regulates 3a,7a,12a-Trihydroxy-5b-cholanic acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 3a,7a,12a-Trihydroxy-5b-cholanic 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 3a,7a,12a-Trihydroxy-5b-cholanic acid supplier is an individual or a company that provides 3a,7a,12a-Trihydroxy-5b-cholanic acid active pharmaceutical ingredient (API) or 3a,7a,12a-Trihydroxy-5b-cholanic acid finished formulations upon request. The 3a,7a,12a-Trihydroxy-5b-cholanic acid suppliers may include 3a,7a,12a-Trihydroxy-5b-cholanic acid API manufacturers, exporters, distributors and traders.
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A 3a,7a,12a-Trihydroxy-5b-cholanic acid DMF (Drug Master File) is a document detailing the whole manufacturing process of 3a,7a,12a-Trihydroxy-5b-cholanic acid active pharmaceutical ingredient (API) in detail. Different forms of 3a,7a,12a-Trihydroxy-5b-cholanic acid DMFs exist exist since differing nations have different regulations, such as 3a,7a,12a-Trihydroxy-5b-cholanic acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 3a,7a,12a-Trihydroxy-5b-cholanic acid DMF submitted to regulatory agencies in the US is known as a USDMF. 3a,7a,12a-Trihydroxy-5b-cholanic acid USDMF includes data on 3a,7a,12a-Trihydroxy-5b-cholanic acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 3a,7a,12a-Trihydroxy-5b-cholanic acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
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We have 4 companies offering 3a,7a,12a-Trihydroxy-5b-cholanic acid
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