01 1M/s Lupin Ltd
01 1Rifampicin EP/BP/USP
01 1WC-0201
01 1India
Date of Issue : 2022-09-30
Valid Till : 2025-09-10
Written Confirmation Number : WC-0201
Address of the Firm : T-142, MIDC, Tarapur, Boisar, Palghar - 401506, Maharashtra, India
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A Rofact manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rofact, including repackagers and relabelers. The FDA regulates Rofact manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rofact 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 Rofact supplier is an individual or a company that provides Rofact active pharmaceutical ingredient (API) or Rofact finished formulations upon request. The Rofact suppliers may include Rofact API manufacturers, exporters, distributors and traders.
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A Rofact written confirmation (Rofact WC) is an official document issued by a regulatory agency to a Rofact manufacturer, verifying that the manufacturing facility of a Rofact active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Rofact APIs or Rofact finished pharmaceutical products to another nation, regulatory agencies frequently require a Rofact WC (written confirmation) as part of the regulatory process.
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