01 1M/s Optimus Drugs Pvt Ltd
01 1Chenodeoxycholic Acid IH/Ph.Eur
01 1WC-0182
01 1India
Chenodeoxycholic Acid IH/Ph.Eur
Date of Issue : 2022-11-02
Valid Till : 2025-07-02
Written Confirmation Number : WC-0182
Address of the Firm : Sy.No.239&240,Dothigudem Village,Pochampally MandalYadadri-Bhuvanagiri,Dist.-508...
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A 3a,7a-dihydroxy-5b-cholanic acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 3a,7a-dihydroxy-5b-cholanic acid, including repackagers and relabelers. The FDA regulates 3a,7a-dihydroxy-5b-cholanic acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 3a,7a-dihydroxy-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-dihydroxy-5b-cholanic acid supplier is an individual or a company that provides 3a,7a-dihydroxy-5b-cholanic acid active pharmaceutical ingredient (API) or 3a,7a-dihydroxy-5b-cholanic acid finished formulations upon request. The 3a,7a-dihydroxy-5b-cholanic acid suppliers may include 3a,7a-dihydroxy-5b-cholanic acid API manufacturers, exporters, distributors and traders.
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A 3a,7a-dihydroxy-5b-cholanic acid written confirmation (3a,7a-dihydroxy-5b-cholanic acid WC) is an official document issued by a regulatory agency to a 3a,7a-dihydroxy-5b-cholanic acid manufacturer, verifying that the manufacturing facility of a 3a,7a-dihydroxy-5b-cholanic acid active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 3a,7a-dihydroxy-5b-cholanic acid APIs or 3a,7a-dihydroxy-5b-cholanic acid finished pharmaceutical products to another nation, regulatory agencies frequently require a 3a,7a-dihydroxy-5b-cholanic acid WC (written confirmation) as part of the regulatory process.
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