01 1M/s Alembic Pharmaceuticals limited
01 1Theophylline Ph. Eur
01 1WC-0082
01 1India
Date of Issue : 2025-08-22
Valid Till : 2028-08-21
Written Confirmation Number : WC-0082
Address of the Firm : Karakhadi, Plot No. 842-843, At - Karakhdi, Tal. - Padra, Dist -Vadodara, Gujara...
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A 1H-purine-2,6-dione manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 1H-purine-2,6-dione, including repackagers and relabelers. The FDA regulates 1H-purine-2,6-dione manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 1H-purine-2,6-dione API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of 1H-purine-2,6-dione manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A 1H-purine-2,6-dione supplier is an individual or a company that provides 1H-purine-2,6-dione active pharmaceutical ingredient (API) or 1H-purine-2,6-dione finished formulations upon request. The 1H-purine-2,6-dione suppliers may include 1H-purine-2,6-dione API manufacturers, exporters, distributors and traders.
click here to find a list of 1H-purine-2,6-dione suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A 1H-purine-2,6-dione written confirmation (1H-purine-2,6-dione WC) is an official document issued by a regulatory agency to a 1H-purine-2,6-dione manufacturer, verifying that the manufacturing facility of a 1H-purine-2,6-dione active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 1H-purine-2,6-dione APIs or 1H-purine-2,6-dione finished pharmaceutical products to another nation, regulatory agencies frequently require a 1H-purine-2,6-dione WC (written confirmation) as part of the regulatory process.
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