01 1Jiaxing Hengjie Biopharmaceutical Co. , Ltd.
02 1Maruha Nichiro Co., Ltd.
03 2Seikagaku Corporation
01 1For a sodium chondroitin sulfate "biochemical" injection
02 2Outsiders regulations sodium chondroitin sulfate
03 1Sodium chondroitin sulfate
01 1China
02 2Japan
03 1U.S.A
Registration Number : 226MF10112
Registrant's Address : No. 20 Tongyi Road, Xingfeng Town, Jiaxing, Zhejiang, China
Initial Date of Registration : 2014-05-29
Latest Date of Registration : 2014-05-29
Sodium chondroitin sulfate for extra-mural use
Registration Number : 217MF10125
Registrant's Address : 2-20 Toyosu 3-chome, Koto-ku, Tokyo
Initial Date of Registration : 2005-05-24
Latest Date of Registration : 2010-01-07
Sodium chondroitin sulfate "Seikagaku" for injection
Registration Number : 217MF10107
Registrant's Address : 1-6-1 Marunouchi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2005-05-23
Latest Date of Registration : 2012-05-08
Sodium chondroitin sulfate for extra-mural use
Registration Number : 217MF10106
Registrant's Address : 1-6-1 Marunouchi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2005-05-23
Latest Date of Registration : 2012-05-08
A Chondroitin Sulfate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Chondroitin Sulfate, including repackagers and relabelers. The FDA regulates Chondroitin Sulfate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Chondroitin Sulfate 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 Chondroitin Sulfate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Chondroitin Sulfate supplier is an individual or a company that provides Chondroitin Sulfate active pharmaceutical ingredient (API) or Chondroitin Sulfate finished formulations upon request. The Chondroitin Sulfate suppliers may include Chondroitin Sulfate API manufacturers, exporters, distributors and traders.
click here to find a list of Chondroitin Sulfate 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 Chondroitin Sulfate Drug Master File in Japan (Chondroitin Sulfate JDMF) empowers Chondroitin Sulfate 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 Chondroitin Sulfate JDMF during the approval evaluation for pharmaceutical products. At the time of Chondroitin Sulfate 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 Chondroitin Sulfate suppliers with JDMF on PharmaCompass.
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