01 1Dipharma
01 17-KETOLITHOCHOLIC ACID
01 1Italy
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32475
Submission : 2018-02-27
Status : Active
Type : II
A 7-Ketolithocholic acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 7-Ketolithocholic acid, including repackagers and relabelers. The FDA regulates 7-Ketolithocholic acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 7-Ketolithocholic 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.
A 7-Ketolithocholic acid supplier is an individual or a company that provides 7-Ketolithocholic acid active pharmaceutical ingredient (API) or 7-Ketolithocholic acid finished formulations upon request. The 7-Ketolithocholic acid suppliers may include 7-Ketolithocholic acid API manufacturers, exporters, distributors and traders.
click here to find a list of 7-Ketolithocholic acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 7-Ketolithocholic acid DMF (Drug Master File) is a document detailing the whole manufacturing process of 7-Ketolithocholic acid active pharmaceutical ingredient (API) in detail. Different forms of 7-Ketolithocholic acid DMFs exist exist since differing nations have different regulations, such as 7-Ketolithocholic acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 7-Ketolithocholic acid DMF submitted to regulatory agencies in the US is known as a USDMF. 7-Ketolithocholic acid USDMF includes data on 7-Ketolithocholic acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 7-Ketolithocholic acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 7-Ketolithocholic acid suppliers with USDMF on PharmaCompass.
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