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...
A Vonoprazan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vonoprazan, including repackagers and relabelers. The FDA regulates Vonoprazan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vonoprazan 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 Vonoprazan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Vonoprazan supplier is an individual or a company that provides Vonoprazan active pharmaceutical ingredient (API) or Vonoprazan finished formulations upon request. The Vonoprazan suppliers may include Vonoprazan API manufacturers, exporters, distributors and traders.
click here to find a list of Vonoprazan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Vonoprazan written confirmation (Vonoprazan WC) is an official document issued by a regulatory agency to a Vonoprazan manufacturer, verifying that the manufacturing facility of a Vonoprazan active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Vonoprazan APIs or Vonoprazan finished pharmaceutical products to another nation, regulatory agencies frequently require a Vonoprazan WC (written confirmation) as part of the regulatory process.
click here to find a list of Vonoprazan suppliers with Written Confirmation (WC) on PharmaCompass.
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