01 1Sumitomo Chemical Co., Ltd.
01 1Japanese Pharmacopoeia propylthiouracil
01 1Japan
Japanese Pharmacopoeia Propylthiouracil
Registration Number : 217MF10086
Registrant's Address : 2-27-1 Shinkawa, Chuo-ku, Tokyo
Initial Date of Registration : 2005-05-23
Latest Date of Registration : 2007-09-06
A Propylthiouracil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Propylthiouracil, including repackagers and relabelers. The FDA regulates Propylthiouracil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Propylthiouracil 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 Propylthiouracil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Propylthiouracil supplier is an individual or a company that provides Propylthiouracil active pharmaceutical ingredient (API) or Propylthiouracil finished formulations upon request. The Propylthiouracil suppliers may include Propylthiouracil API manufacturers, exporters, distributors and traders.
click here to find a list of Propylthiouracil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price 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 Propylthiouracil Drug Master File in Japan (Propylthiouracil JDMF) empowers Propylthiouracil 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 Propylthiouracil JDMF during the approval evaluation for pharmaceutical products. At the time of Propylthiouracil 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 Propylthiouracil suppliers with JDMF on PharmaCompass.
We have 1 companies offering Propylthiouracil
Get in contact with the supplier of your choice:
LOOKING FOR A SUPPLIER?
