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