01 1JEIL PHARMACEUTICAL CO. , LTD.
02 1Yungjin Pharm. Co. ,Ltd
01 2Sefukapen pivoxil hydrochloride hydrate
01 2South Korea
Cefcapene Pivoxil Hydrochloride Hydrate
Registration Number : 224MF10036
Registrant's Address : 343, Sapyeong-daero, Seocho-gu, Seoul, Korea
Initial Date of Registration : 2012-02-23
Latest Date of Registration : 2012-02-23
Cefcapene Pivoxil Hydrochloride Hydrate
Registration Number : 220MF10012
Registrant's Address : 13, Olympic-ro 35da-gil, Songpa-gu, Seoul, Korea
Initial Date of Registration : 2008-01-09
Latest Date of Registration : 2020-07-09
A Cefcapene Pivoxil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cefcapene Pivoxil, including repackagers and relabelers. The FDA regulates Cefcapene Pivoxil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cefcapene Pivoxil 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 Cefcapene Pivoxil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cefcapene Pivoxil supplier is an individual or a company that provides Cefcapene Pivoxil active pharmaceutical ingredient (API) or Cefcapene Pivoxil finished formulations upon request. The Cefcapene Pivoxil suppliers may include Cefcapene Pivoxil API manufacturers, exporters, distributors and traders.
click here to find a list of Cefcapene Pivoxil 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 Cefcapene Pivoxil Drug Master File in Japan (Cefcapene Pivoxil JDMF) empowers Cefcapene Pivoxil 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 Cefcapene Pivoxil JDMF during the approval evaluation for pharmaceutical products. At the time of Cefcapene Pivoxil 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 Cefcapene Pivoxil suppliers with JDMF on PharmaCompass.
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