01 1Kyowa Pharma Chemical Co., Ltd.
01 1Japanese Pharmacopoeia Pirushikainido hydrochloride hydrate (production only)
01 1Japan
Japanese Pharmacopoeia Pilsicainide Hydrochloride Hydrate (For manufacturing only)
Registration Number : 227MF10058
Registrant's Address : 530 Chokeiji, Takaoka City, Toyama Prefecture
Initial Date of Registration : 2015-03-06
Latest Date of Registration : 2015-03-06
A Benzamidine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Benzamidine, including repackagers and relabelers. The FDA regulates Benzamidine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Benzamidine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Benzamidine supplier is an individual or a company that provides Benzamidine active pharmaceutical ingredient (API) or Benzamidine finished formulations upon request. The Benzamidine suppliers may include Benzamidine API manufacturers, exporters, distributors and traders.
click here to find a list of Benzamidine 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 Benzamidine Drug Master File in Japan (Benzamidine JDMF) empowers Benzamidine 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 Benzamidine JDMF during the approval evaluation for pharmaceutical products. At the time of Benzamidine 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 Benzamidine suppliers with JDMF on PharmaCompass.
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