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
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A (3alpha,5beta,7alpha,8x,12alpha)-3,7,12-trihydroxycholan-24-oic acid DMF (Drug Master File) is a document detailing the whole manufacturing process of (3alpha,5beta,7alpha,8x,12alpha)-3,7,12-trihydroxycholan-24-oic acid active pharmaceutical ingredient (API) in detail. Different forms of (3alpha,5beta,7alpha,8x,12alpha)-3,7,12-trihydroxycholan-24-oic acid DMFs exist exist since differing nations have different regulations, such as (3alpha,5beta,7alpha,8x,12alpha)-3,7,12-trihydroxycholan-24-oic acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
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We have 4 companies offering (3alpha,5beta,7alpha,8x,12alpha)-3,7,12-trihydroxycholan-24-oic acid
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