01 1M/s. Mylan Lab Ltd.
01 1Erlotinib HCL (INH)
01 1WC-0157
01 1India
Date of Issue : 2019-10-11
Valid Till : 2022-07-02
Written Confirmation Number : WC-0157
Address of the Firm : Plot No. 1A/2, MIDC, Taloja, Panvel, Dist. Raigad, Maharashtra State
77
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A Tarceva manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tarceva, including repackagers and relabelers. The FDA regulates Tarceva manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tarceva 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 Tarceva supplier is an individual or a company that provides Tarceva active pharmaceutical ingredient (API) or Tarceva finished formulations upon request. The Tarceva suppliers may include Tarceva API manufacturers, exporters, distributors and traders.
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A Tarceva written confirmation (Tarceva WC) is an official document issued by a regulatory agency to a Tarceva manufacturer, verifying that the manufacturing facility of a Tarceva active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tarceva APIs or Tarceva finished pharmaceutical products to another nation, regulatory agencies frequently require a Tarceva WC (written confirmation) as part of the regulatory process.
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