01 1Jiangxi Dongfeng Pharmaceutical Co. , Ltd.
02 1Sandoz Industrial Products GmbH
01 1BENZYLPENICILLIN BENZATHINE HYDRATE
02 1Benzylpenicillin benzathine (1% Lecithin, 0.2% Tween)
01 1China
02 1Switzerland
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
Benzylpenicillin Benzathine (1% lecithin, 0.2% Tween)
Registration Number : 220MF10136
Registrant's Address : Industrypark Hoechst Brueningstrasse 50 D-65929 Frankfurt am Main Germany
Initial Date of Registration : 2008-05-29
Latest Date of Registration : 2008-05-29
A Penicillin G Benzathine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Penicillin G Benzathine, including repackagers and relabelers. The FDA regulates Penicillin G Benzathine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 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.
click here to find a list of Penicillin G Benzathine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Penicillin G Benzathine supplier is an individual or a company that provides Penicillin G Benzathine active pharmaceutical ingredient (API) or Penicillin G Benzathine finished formulations upon request. The Penicillin G Benzathine suppliers may include Penicillin G Benzathine API manufacturers, exporters, distributors and traders.
click here to find a list of Penicillin G Benzathine 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 G Benzathine Drug Master File in Japan (Penicillin G Benzathine JDMF) empowers 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 Penicillin G Benzathine JDMF during the approval evaluation for pharmaceutical products. At the time 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.
click here to find a list of Penicillin G Benzathine suppliers with JDMF on PharmaCompass.
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