Registration Number : 230MF10011
Registrant's Address : 6-2-10 Ginza, Chuo-ku, Tokyo
Initial Date of Registration : 2018-01-24
Latest Date of Registration : 2018-01-24
A Penicillin V manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Penicillin V, including repackagers and relabelers. The FDA regulates Penicillin V manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Penicillin V 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 Penicillin V manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Penicillin V supplier is an individual or a company that provides Penicillin V active pharmaceutical ingredient (API) or Penicillin V finished formulations upon request. The Penicillin V suppliers may include Penicillin V API manufacturers, exporters, distributors and traders.
click here to find a list of Penicillin V 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 Penicillin V Drug Master File in Japan (Penicillin V JDMF) empowers Penicillin V 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 Penicillin V JDMF during the approval evaluation for pharmaceutical products. At the time of Penicillin V 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 Penicillin V suppliers with JDMF on PharmaCompass.
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