01 2Komatsuya Co., Ltd.
02 1Kyongbo Pharmaceutical Co. , Ltd.
03 1Satsuma Chemical Co., Ltd.
01 1Day stations mosapride acid hydrate (production only)
02 1Japanese Pharmaceutical Codex sodium ferrous citrate
03 2Japanese Pharmacopoeia sodium citrate hydrate
01 3Japan
02 1South Korea
Japanese Pharmacopoeia Non-Drug Standards Sodium Ferrous Citrate
Registration Number : 224MF10212
Registrant's Address : Matsuura Sakaisuji Honmachi Building, 1-9-28, Kyutaro-cho, Chuo-ku, Osaka City, Osaka...
Initial Date of Registration : 2012-10-29
Latest Date of Registration : 2012-10-29
Japanese Pharmacopoeia Sodium Citrate Hydrate
Registration Number : 219MF10179
Registrant's Address : Matsuura Sakaisuji Honmachi Building, 1-9-28, Kyutaro-cho, Chuo-ku, Osaka City, Osaka...
Initial Date of Registration : 2007-06-01
Latest Date of Registration : 2007-06-01
Mosapride Citrate Hydrate (JP) (for manufacturing purposes only)
Registration Number : 223MF10104
Registrant's Address : 174, Sirok-ro, Asan-si, Chungcheongnam-do, KOREA
Initial Date of Registration : 2011-07-15
Latest Date of Registration : 2011-07-15
Japanese Pharmacopoeia Sodium Citrate Hydrate
Registration Number : 218MF10737
Registrant's Address : 1451 Kaseda Kawabata, Minamisatsuma City, Kagoshima Prefecture
Initial Date of Registration : 2006-09-06
Latest Date of Registration : 2007-09-28
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PharmaCompass offers a list of Citric Acid API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Citric Acid manufacturer or Citric Acid supplier for your needs.
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A Kyselina citronova manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Kyselina citronova, including repackagers and relabelers. The FDA regulates Kyselina citronova manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Kyselina citronova API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Kyselina citronova supplier is an individual or a company that provides Kyselina citronova active pharmaceutical ingredient (API) or Kyselina citronova finished formulations upon request. The Kyselina citronova suppliers may include Kyselina citronova API manufacturers, exporters, distributors and traders.
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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 Kyselina citronova Drug Master File in Japan (Kyselina citronova JDMF) empowers Kyselina citronova 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 Kyselina citronova JDMF during the approval evaluation for pharmaceutical products. At the time of Kyselina citronova JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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