01 1Dipharma
01 1Italy
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32475
Submission : 2018-02-27
Status : Active
Type : II
NDC Package Code : 46438-0646
Start Marketing Date : 2018-08-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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.
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