01 1Henan Quanyu Pharmaceutical Co. , Ltd.
01 1Tiopronin
01 1China
Registration Number : 303MF10092
Registrant's Address : Industrial Park, Neixiang County, Nanyang City, Henan, China
Initial Date of Registration : 2021-06-09
Latest Date of Registration : 2021-06-09
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A alpha-mercaptopropionyl glycine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of alpha-mercaptopropionyl glycine, including repackagers and relabelers. The FDA regulates alpha-mercaptopropionyl glycine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. alpha-mercaptopropionyl glycine 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 alpha-mercaptopropionyl glycine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A alpha-mercaptopropionyl glycine supplier is an individual or a company that provides alpha-mercaptopropionyl glycine active pharmaceutical ingredient (API) or alpha-mercaptopropionyl glycine finished formulations upon request. The alpha-mercaptopropionyl glycine suppliers may include alpha-mercaptopropionyl glycine API manufacturers, exporters, distributors and traders.
click here to find a list of alpha-mercaptopropionyl glycine suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The alpha-mercaptopropionyl glycine Drug Master File in Japan (alpha-mercaptopropionyl glycine JDMF) empowers alpha-mercaptopropionyl glycine API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the alpha-mercaptopropionyl glycine JDMF during the approval evaluation for pharmaceutical products. At the time of alpha-mercaptopropionyl glycine JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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