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 Alendronate Sodium Trihydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alendronate Sodium Trihydrate, including repackagers and relabelers. The FDA regulates Alendronate Sodium Trihydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alendronate Sodium Trihydrate 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 Alendronate Sodium Trihydrate written confirmation (Alendronate Sodium Trihydrate WC) is an official document issued by a regulatory agency to a Alendronate Sodium Trihydrate manufacturer, verifying that the manufacturing facility of a Alendronate Sodium Trihydrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Alendronate Sodium Trihydrate APIs or Alendronate Sodium Trihydrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Alendronate Sodium Trihydrate WC (written confirmation) as part of the regulatory process.
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