01 1Cheer Fine Pharmaceutical Co. , Ltd.
02 1Kyowa Pharma Chemical Co., Ltd.
01 1Cetraxate Hydrochloride
02 1Japanese Pharmacopoeia cetraxate hydrochloride (production only)
01 1China
02 1Japan
Registration Number : 302MF10053
Registrant's Address : No. 2066 Tangkou Road, Economy and Technology Development Zone, Hefei, Anhui Province...
Initial Date of Registration : 2020-05-12
Latest Date of Registration : 2020-05-12
Japanese Pharmacopoeia Cetraxate Hydrochloride (for manufacturing only)
Registration Number : 222MF10065
Registrant's Address : 530 Chokeiji, Takaoka City, Toyama Prefecture
Initial Date of Registration : 2010-02-22
Latest Date of Registration : 2010-02-22
A Cetraxate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cetraxate, including repackagers and relabelers. The FDA regulates Cetraxate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cetraxate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Cetraxate supplier is an individual or a company that provides Cetraxate active pharmaceutical ingredient (API) or Cetraxate finished formulations upon request. The Cetraxate suppliers may include Cetraxate API manufacturers, exporters, distributors and traders.
click here to find a list of Cetraxate 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 Cetraxate Drug Master File in Japan (Cetraxate JDMF) empowers Cetraxate 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 Cetraxate JDMF during the approval evaluation for pharmaceutical products. At the time of Cetraxate 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 Cetraxate suppliers with JDMF on PharmaCompass.
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