01 1Jiangxi Dongfeng Pharmaceutical Co. , Ltd.
01 1BENZYLPENICILLIN BENZATHINE HYDRATE
01 1China
BENZYLPENICILLIN BENZATHINE HYDRATE
Registration Number : 219MF10336
Registrant's Address : 15 Dongfeng Rd. , Leping City, Jiangxi Province, China
Initial Date of Registration : 2007-11-21
Latest Date of Registration : 2007-11-21
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A Benzatina bencilpenicilina manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Benzatina bencilpenicilina, including repackagers and relabelers. The FDA regulates Benzatina bencilpenicilina manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Benzatina bencilpenicilina API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Benzatina bencilpenicilina supplier is an individual or a company that provides Benzatina bencilpenicilina active pharmaceutical ingredient (API) or Benzatina bencilpenicilina finished formulations upon request. The Benzatina bencilpenicilina suppliers may include Benzatina bencilpenicilina API manufacturers, exporters, distributors and traders.
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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 Benzatina bencilpenicilina Drug Master File in Japan (Benzatina bencilpenicilina JDMF) empowers Benzatina bencilpenicilina 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 Benzatina bencilpenicilina JDMF during the approval evaluation for pharmaceutical products. At the time of Benzatina bencilpenicilina JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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