01 1Sumitomo Chemical Co., Ltd.
01 1Japanese Pharmacopoeia propylthiouracil
01 1Japan
Japanese Pharmacopoeia Propylthiouracil
Registration Number : 217MF10086
Registrant's Address : 2-7-1 Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2005-05-23
Latest Date of Registration : 2007-09-06
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A thyreostat propyl-thyracil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of thyreostat propyl-thyracil, including repackagers and relabelers. The FDA regulates thyreostat propyl-thyracil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. thyreostat propyl-thyracil 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 thyreostat propyl-thyracil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A thyreostat propyl-thyracil supplier is an individual or a company that provides thyreostat propyl-thyracil active pharmaceutical ingredient (API) or thyreostat propyl-thyracil finished formulations upon request. The thyreostat propyl-thyracil suppliers may include thyreostat propyl-thyracil API manufacturers, exporters, distributors and traders.
click here to find a list of thyreostat propyl-thyracil 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 thyreostat propyl-thyracil Drug Master File in Japan (thyreostat propyl-thyracil JDMF) empowers thyreostat propyl-thyracil 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 thyreostat propyl-thyracil JDMF during the approval evaluation for pharmaceutical products. At the time of thyreostat propyl-thyracil JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of thyreostat propyl-thyracil suppliers with JDMF on PharmaCompass.
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