Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.
01 1M/s Bal Pharma Limited
01 1Bepotastine Besilate JP/IH
01 1WC-0156
01 1India
Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.
Date of Issue : 2022-08-25
Valid Till : 2025-07-02
Written Confirmation Number : WC-0156
Address of the Firm : 61-B, Bommasandra Industrial Area, Bengaluru-560 099, India
90
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A Bepreve manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bepreve, including repackagers and relabelers. The FDA regulates Bepreve manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bepreve 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 Bepreve supplier is an individual or a company that provides Bepreve active pharmaceutical ingredient (API) or Bepreve finished formulations upon request. The Bepreve suppliers may include Bepreve API manufacturers, exporters, distributors and traders.
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A Bepreve written confirmation (Bepreve WC) is an official document issued by a regulatory agency to a Bepreve manufacturer, verifying that the manufacturing facility of a Bepreve active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Bepreve APIs or Bepreve finished pharmaceutical products to another nation, regulatory agencies frequently require a Bepreve WC (written confirmation) as part of the regulatory process.
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