Apex Healthcare Limited: ISO 9001:2008, WHO-GMP, US FDA-audited manufacturer & exporter of APIs, bulk drugs, and formulations.
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Apex Healthcare Limited: ISO 9001:2008, WHO-GMP, US FDA-audited manufacturer & exporter of APIs, bulk drugs, and formulations.
Date of Issue : 2024-03-01
Valid Till : 2026-12-31
Written Confirmation Number : WC-0409
Address of the Firm : 4710, 4711, 4707-A/8, 4707-A/9, GIDC, Industrial Estate, Ankleshwar, Dist.Bharuc...
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A Sitavig manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sitavig, including repackagers and relabelers. The FDA regulates Sitavig manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sitavig 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 Sitavig supplier is an individual or a company that provides Sitavig active pharmaceutical ingredient (API) or Sitavig finished formulations upon request. The Sitavig suppliers may include Sitavig API manufacturers, exporters, distributors and traders.
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A Sitavig written confirmation (Sitavig WC) is an official document issued by a regulatory agency to a Sitavig manufacturer, verifying that the manufacturing facility of a Sitavig active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sitavig APIs or Sitavig finished pharmaceutical products to another nation, regulatory agencies frequently require a Sitavig WC (written confirmation) as part of the regulatory process.
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