01 1M/s Glenmark Life Sciences Limited
02 1M/s Nitika Pharmaceutical Specialities Pvt Ltd
01 1Potassium Chloride (IP/BP/Ph.Eur/USI)
02 1Potassium Chloride API BP
01 1WC-0310
02 1WC-0452
01 2India
Potassium Chloride (IP/BP/Ph.Eur/USI)
Date of Issue : 2023-12-28
Valid Till : 2026-12-28
Written Confirmation Number : WC-0310
Address of the Firm : Plot No. Z-103/l, Dahej SEZ, Phase ll, Dahej, Dist-Bharuch, Gujarat
Date of Issue : 2019-09-11
Valid Till : 2022-09-10
Written Confirmation Number : WC-0452
Address of the Firm : Block No.3 of Plot No. 1296, 1297/08, Ward No. 03, Mouza- Waddhamna, Amravati Ro...
A K-Dur manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of K-Dur, including repackagers and relabelers. The FDA regulates K-Dur manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. K-Dur API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of K-Dur manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A K-Dur supplier is an individual or a company that provides K-Dur active pharmaceutical ingredient (API) or K-Dur finished formulations upon request. The K-Dur suppliers may include K-Dur API manufacturers, exporters, distributors and traders.
click here to find a list of K-Dur suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A K-Dur written confirmation (K-Dur WC) is an official document issued by a regulatory agency to a K-Dur manufacturer, verifying that the manufacturing facility of a K-Dur active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting K-Dur APIs or K-Dur finished pharmaceutical products to another nation, regulatory agencies frequently require a K-Dur WC (written confirmation) as part of the regulatory process.
click here to find a list of K-Dur suppliers with Written Confirmation (WC) on PharmaCompass.
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