01 1M/s. Aurobindo Pharma Ltd.,
01 1Ribavirin (EP)
01 1WC-0120
01 1India
Date of Issue : 2022-07-15
Valid Till : 2025-07-02
Written Confirmation Number : WC-0120
Address of the Firm : Unit-1, Sy. No. 388 & 389, Borpatla (V), Hatnoora (M), Medak (Dist).502 296 A.P....
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A Copegus manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Copegus, including repackagers and relabelers. The FDA regulates Copegus manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Copegus 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 Copegus supplier is an individual or a company that provides Copegus active pharmaceutical ingredient (API) or Copegus finished formulations upon request. The Copegus suppliers may include Copegus API manufacturers, exporters, distributors and traders.
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A Copegus written confirmation (Copegus WC) is an official document issued by a regulatory agency to a Copegus manufacturer, verifying that the manufacturing facility of a Copegus active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Copegus APIs or Copegus finished pharmaceutical products to another nation, regulatory agencies frequently require a Copegus WC (written confirmation) as part of the regulatory process.
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