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 Sandoz Brand of Penicillin G Benzathine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sandoz Brand of Penicillin G Benzathine, including repackagers and relabelers. The FDA regulates Sandoz Brand of Penicillin G Benzathine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sandoz Brand of Penicillin G Benzathine 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 Sandoz Brand of Penicillin G Benzathine supplier is an individual or a company that provides Sandoz Brand of Penicillin G Benzathine active pharmaceutical ingredient (API) or Sandoz Brand of Penicillin G Benzathine finished formulations upon request. The Sandoz Brand of Penicillin G Benzathine suppliers may include Sandoz Brand of Penicillin G Benzathine 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 Sandoz Brand of Penicillin G Benzathine Drug Master File in Japan (Sandoz Brand of Penicillin G Benzathine JDMF) empowers Sandoz Brand of Penicillin G Benzathine 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 Sandoz Brand of Penicillin G Benzathine JDMF during the approval evaluation for pharmaceutical products. At the time of Sandoz Brand of Penicillin G Benzathine 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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