01 1M/s Lupin Limited
01 1Cefadroxil USP
01 1WC-0048n
01 1India
Date of Issue : 2022-03-06
Valid Till : 2025-07-31
Written Confirmation Number : WC-0048n
Address of the Firm : Plot No. - 9, 123, 123/1, 124 & 125, G.I.D.C Estate, Ankleshwar, Dist.- Bharuch-...
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A Oracefal manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oracefal, including repackagers and relabelers. The FDA regulates Oracefal manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oracefal 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 Oracefal supplier is an individual or a company that provides Oracefal active pharmaceutical ingredient (API) or Oracefal finished formulations upon request. The Oracefal suppliers may include Oracefal API manufacturers, exporters, distributors and traders.
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A Oracefal written confirmation (Oracefal WC) is an official document issued by a regulatory agency to a Oracefal manufacturer, verifying that the manufacturing facility of a Oracefal active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Oracefal APIs or Oracefal finished pharmaceutical products to another nation, regulatory agencies frequently require a Oracefal WC (written confirmation) as part of the regulatory process.
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