China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
01 1Shandong Chenghui Shuangda Pharmaceutical Co., Ltd
02 1M/s Ami Lifesciences
01 1Vonoprazan Fumarate
02 1Vonoprazan Fumarate IH
01 1SD240003
02 1WC-0054
01 1China
02 1India
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
Date of Issue : 2024-01-15
Valid Till : 2027-01-14
Written Confirmation Number : SD240003
Address of the Firm : Economic Development Zone, Pingyuan County, Dezhou City, Shandong, PR China
AMI Lifesciences is Driven by Chemistry. Powered by People.
Date of Issue : 2022-08-11
Valid Till : 2025-06-26
Written Confirmation Number : WC-0054
Address of the Firm : Block No. 82/B, ECP Road, At & Post. Karakhadi, Tal-Padra, City Karakhadi -39145...
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A Vonoprazan Fumarate (TAK-438) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vonoprazan Fumarate (TAK-438), including repackagers and relabelers. The FDA regulates Vonoprazan Fumarate (TAK-438) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vonoprazan Fumarate (TAK-438) 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 Vonoprazan Fumarate (TAK-438) supplier is an individual or a company that provides Vonoprazan Fumarate (TAK-438) active pharmaceutical ingredient (API) or Vonoprazan Fumarate (TAK-438) finished formulations upon request. The Vonoprazan Fumarate (TAK-438) suppliers may include Vonoprazan Fumarate (TAK-438) API manufacturers, exporters, distributors and traders.
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A Vonoprazan Fumarate (TAK-438) written confirmation (Vonoprazan Fumarate (TAK-438) WC) is an official document issued by a regulatory agency to a Vonoprazan Fumarate (TAK-438) manufacturer, verifying that the manufacturing facility of a Vonoprazan Fumarate (TAK-438) active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Vonoprazan Fumarate (TAK-438) APIs or Vonoprazan Fumarate (TAK-438) finished pharmaceutical products to another nation, regulatory agencies frequently require a Vonoprazan Fumarate (TAK-438) WC (written confirmation) as part of the regulatory process.
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