01 1MSN Laboratories Pvt. Ltd.
01 1Acalabrutinib IH
01 1WC-0349
01 1India
Date of Issue : 2022-09-02
Valid Till : 2025-05-05
Written Confirmation Number : WC-0349
Address of the Firm : MIs. MSN Laboratories Private Limited, Unit-II, sv. No, 50, Kardanur (Village), ...
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A Calquence manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Calquence, including repackagers and relabelers. The FDA regulates Calquence manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Calquence 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 Calquence supplier is an individual or a company that provides Calquence active pharmaceutical ingredient (API) or Calquence finished formulations upon request. The Calquence suppliers may include Calquence API manufacturers, exporters, distributors and traders.
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A Calquence written confirmation (Calquence WC) is an official document issued by a regulatory agency to a Calquence manufacturer, verifying that the manufacturing facility of a Calquence active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Calquence APIs or Calquence finished pharmaceutical products to another nation, regulatory agencies frequently require a Calquence WC (written confirmation) as part of the regulatory process.
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