01 1JEIL PHARMACEUTICAL CO. , LTD.
01 1Cefteram pivoxil
01 1South Korea
Registration Number : 218MF10219
Registrant's Address : 343, Sapyeong-daero, Seocho-gu, Seoul, Korea
Initial Date of Registration : 2006-02-16
Latest Date of Registration : 2006-11-06
A Cefteram Pivoxil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cefteram Pivoxil, including repackagers and relabelers. The FDA regulates Cefteram Pivoxil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cefteram 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 Cefteram Pivoxil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cefteram Pivoxil supplier is an individual or a company that provides Cefteram Pivoxil active pharmaceutical ingredient (API) or Cefteram Pivoxil finished formulations upon request. The Cefteram Pivoxil suppliers may include Cefteram Pivoxil API manufacturers, exporters, distributors and traders.
click here to find a list of Cefteram 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 Cefteram Pivoxil Drug Master File in Japan (Cefteram Pivoxil JDMF) empowers Cefteram 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 Cefteram Pivoxil JDMF during the approval evaluation for pharmaceutical products. At the time of Cefteram 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 Cefteram Pivoxil suppliers with JDMF on PharmaCompass.
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