01 1Sumitomo Chemical Co., Ltd.
01 1Japanese Pharmacopoeia hydralazine hydrochloride
01 1Japan
Japanese Pharmacopoeia Hydralazine Hydrochloride
Registration Number : 219MF10233
Registrant's Address : 2-27-1 Shinkawa, Chuo-ku, Tokyo
Initial Date of Registration : 2007-07-06
Latest Date of Registration : 2017-05-16
A Hyperex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hyperex, including repackagers and relabelers. The FDA regulates Hyperex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hyperex 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 Hyperex manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hyperex supplier is an individual or a company that provides Hyperex active pharmaceutical ingredient (API) or Hyperex finished formulations upon request. The Hyperex suppliers may include Hyperex API manufacturers, exporters, distributors and traders.
click here to find a list of Hyperex 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 Hyperex Drug Master File in Japan (Hyperex JDMF) empowers Hyperex 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 Hyperex JDMF during the approval evaluation for pharmaceutical products. At the time of Hyperex 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 Hyperex suppliers with JDMF on PharmaCompass.
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