Alchem offers Phytochemical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.
01 1M/s Alchem International Private Limited
01 1Hyoscine EP
01 1WC-0006
01 1India
Alchem offers Phytochemical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.
Date of Issue : 2022-05-27
Valid Till : 2025-05-26
Written Confirmation Number : WC-0006
Address of the Firm : 25/2, Main Mathura Road, Vill- Kaili, Ballabgarh, Faridabad-121 004, Haryana, In...
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A Tropane alkaloid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tropane alkaloid, including repackagers and relabelers. The FDA regulates Tropane alkaloid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tropane alkaloid 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 Tropane alkaloid written confirmation (Tropane alkaloid WC) is an official document issued by a regulatory agency to a Tropane alkaloid manufacturer, verifying that the manufacturing facility of a Tropane alkaloid active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tropane alkaloid APIs or Tropane alkaloid finished pharmaceutical products to another nation, regulatory agencies frequently require a Tropane alkaloid WC (written confirmation) as part of the regulatory process.
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