01 1Daiwa Pharmaceutical Industries Co., Ltd.
01 1Japanese Pharmacopoeia Drug trapidil (production only)
01 1India
Japanese Pharmacopoeia Drug Trapidil (for manufacturing only)
Registration Number : 217MF10510
Registrant's Address : 2-3-5 Shimookui, Toyama City, Toyama Prefecture
Initial Date of Registration : 2005-09-06
Latest Date of Registration : 2006-12-01
A Trapidil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trapidil, including repackagers and relabelers. The FDA regulates Trapidil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trapidil 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 Trapidil supplier is an individual or a company that provides Trapidil active pharmaceutical ingredient (API) or Trapidil finished formulations upon request. The Trapidil suppliers may include Trapidil API manufacturers, exporters, distributors and traders.
click here to find a list of Trapidil 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 Trapidil Drug Master File in Japan (Trapidil JDMF) empowers Trapidil 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 Trapidil JDMF during the approval evaluation for pharmaceutical products. At the time of Trapidil 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 Trapidil suppliers with JDMF on PharmaCompass.
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