01 2ACS DOBFAR S. p. A.
02 1Zhejiang Dongbang Pharmaceutical Co. , Ltd.
01 3Cefaclor
01 1China
02 2Italy
Registration Number : 218MF10591
Registrant's Address : Viale Addetta, 4/12, 20067 Tribiano (Milan) Italy
Initial Date of Registration : 2006-06-22
Latest Date of Registration : 2015-06-26
Registration Number : 227MF10171
Registrant's Address : Viale Addetta, 4/12, 20067 Tribiano (Milan) Italy
Initial Date of Registration : 2015-06-18
Latest Date of Registration : 2015-06-18
Registration Number : 230MF10134
Registrant's Address : Pharm-Chem zone, Duqiao, Linhai, Taizhou, Zhejiang, China
Initial Date of Registration : 2018-09-14
Latest Date of Registration : 2018-09-14
A Cefaclor manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cefaclor, including repackagers and relabelers. The FDA regulates Cefaclor manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cefaclor 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 Cefaclor manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cefaclor supplier is an individual or a company that provides Cefaclor active pharmaceutical ingredient (API) or Cefaclor finished formulations upon request. The Cefaclor suppliers may include Cefaclor API manufacturers, exporters, distributors and traders.
click here to find a list of Cefaclor 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 Cefaclor Drug Master File in Japan (Cefaclor JDMF) empowers Cefaclor 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 Cefaclor JDMF during the approval evaluation for pharmaceutical products. At the time of Cefaclor 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 Cefaclor suppliers with JDMF on PharmaCompass.
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