01 1M/s Aurore Pharmaceuticals Private limited
02 1M/s Piramal Pharma Limited
01 1Sulindac IHS
02 1Sulindac USP/Ph. Eur
01 1WC-0119
02 1WC-0123
01 2India
Date of Issue : 2022-09-19
Valid Till : 2025-07-02
Written Confirmation Number : WC-0119
Address of the Firm : Plot No. 35, 36, 38, 39, 40, 49, 50 & 51, Phase-IV, IDA, Jeedimetla, Medchal-Mal...
Date of Issue : 2022-06-29
Valid Till : 2025-02-07
Written Confirmation Number : WC-0123
Address of the Firm : Sy. Nos. 7-70, 70/1 & 70/2, Digwal Village, Kohir Mandai, Sangareddy District, T...
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A BRD-A13946108-001-04-9 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of BRD-A13946108-001-04-9, including repackagers and relabelers. The FDA regulates BRD-A13946108-001-04-9 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. BRD-A13946108-001-04-9 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 BRD-A13946108-001-04-9 written confirmation (BRD-A13946108-001-04-9 WC) is an official document issued by a regulatory agency to a BRD-A13946108-001-04-9 manufacturer, verifying that the manufacturing facility of a BRD-A13946108-001-04-9 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting BRD-A13946108-001-04-9 APIs or BRD-A13946108-001-04-9 finished pharmaceutical products to another nation, regulatory agencies frequently require a BRD-A13946108-001-04-9 WC (written confirmation) as part of the regulatory process.
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