01 1JEIL PHARMACEUTICAL CO. , LTD.
02 1Meiji Seika Pharma Co., Ltd.
03 2Yungjin Pharm. Co. ,Ltd
01 2Cefditoren Pivoxil
02 2Cefditoren pivoxil
01 1Japan
02 3South Korea
Registration Number : 219MF10254
Registrant's Address : 343, Sapyeong-daero, Seocho-gu, Seoul, Korea
Initial Date of Registration : 2007-08-06
Latest Date of Registration : 2007-08-06
Registration Number : 302MF10072
Registrant's Address : 2-4-16 Kyobashi, Chuo-ku, Tokyo
Initial Date of Registration : 2020-06-26
Latest Date of Registration : 2020-06-26
Registration Number : 306MF10127
Registrant's Address : 13, Olympic-ro 35da-gil, Songpa-gu, Seoul, Korea
Initial Date of Registration : 2024-09-18
Latest Date of Registration : 2024-09-18
Registration Number : 228MF10040
Registrant's Address : 13, Olympic-ro 35da-gil, Songpa-gu, Seoul, Korea
Initial Date of Registration : 2016-02-08
Latest Date of Registration : 2016-02-08
A Cefditoren Pivoxil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cefditoren Pivoxil, including repackagers and relabelers. The FDA regulates Cefditoren Pivoxil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cefditoren 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 Cefditoren Pivoxil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cefditoren Pivoxil supplier is an individual or a company that provides Cefditoren Pivoxil active pharmaceutical ingredient (API) or Cefditoren Pivoxil finished formulations upon request. The Cefditoren Pivoxil suppliers may include Cefditoren Pivoxil API manufacturers, exporters, distributors and traders.
click here to find a list of Cefditoren 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 Cefditoren Pivoxil Drug Master File in Japan (Cefditoren Pivoxil JDMF) empowers Cefditoren 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 Cefditoren Pivoxil JDMF during the approval evaluation for pharmaceutical products. At the time of Cefditoren 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 Cefditoren Pivoxil suppliers with JDMF on PharmaCompass.
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