01 1M/s. Cadila Healthcare Limited,
01 1Tirofiban Hydrochloride IH
01 1WC-0084
01 1India
Date of Issue : 2019-07-15
Valid Till : 2022-07-14
Written Confirmation Number : WC-0084
Address of the Firm : Plot No 26, 29 & 31, Umraya Road, Village Dabhasa, Tal -Padra- 381 440, Vadodara...
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A AGGRASTAT manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of AGGRASTAT, including repackagers and relabelers. The FDA regulates AGGRASTAT manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. AGGRASTAT 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 AGGRASTAT supplier is an individual or a company that provides AGGRASTAT active pharmaceutical ingredient (API) or AGGRASTAT finished formulations upon request. The AGGRASTAT suppliers may include AGGRASTAT API manufacturers, exporters, distributors and traders.
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A AGGRASTAT written confirmation (AGGRASTAT WC) is an official document issued by a regulatory agency to a AGGRASTAT manufacturer, verifying that the manufacturing facility of a AGGRASTAT active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting AGGRASTAT APIs or AGGRASTAT finished pharmaceutical products to another nation, regulatory agencies frequently require a AGGRASTAT WC (written confirmation) as part of the regulatory process.
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