01 2Komatsuya Co., Ltd.
02 1Kyongbo Pharmaceutical Co. , Ltd.
03 1Sanyo Chemical Research Institute Co., Ltd.
04 1Satsuma Chemical Co., Ltd.
01 1Citric acid tandospirone
02 1Day stations mosapride acid hydrate (production only)
03 1Japanese Pharmaceutical Codex sodium ferrous citrate
04 2Japanese Pharmacopoeia sodium citrate hydrate
01 1Gabon
02 3Japan
03 1South Korea
Japanese Pharmacopoeia Sodium Citrate Hydrate
Registration Number : 219MF10179
Registrant's Address : Matsuura Sakaisuji Honmachi Building, 1-9-28 Kyutarocho, Chuo-ku, Osaka City, Osaka P...
Initial Date of Registration : 2007-06-01
Latest Date of Registration : 2007-06-01
Japanese Pharmacopoeia Non-Drug Standards Sodium Ferrous Citrate
Registration Number : 224MF10212
Registrant's Address : Matsuura Sakaisuji Honmachi Building, 1-9-28 Kyutarocho, Chuo-ku, Osaka City, Osaka P...
Initial Date of Registration : 2012-10-29
Latest Date of Registration : 2012-10-29
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
Registration Number : 218MF10268
Registrant's Address : 148-1 Tajii, Mihara-ku, Sakai City, Osaka Prefecture
Initial Date of Registration : 2006-02-17
Latest Date of Registration : 2006-07-20
A Citric Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Citric Acid, including repackagers and relabelers. The FDA regulates Citric Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Citric Acid 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 Citric Acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Citric Acid supplier is an individual or a company that provides Citric Acid active pharmaceutical ingredient (API) or Citric Acid finished formulations upon request. The Citric Acid suppliers may include Citric Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Citric Acid 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 Citric Acid Drug Master File in Japan (Citric Acid JDMF) empowers Citric Acid 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 Citric Acid JDMF during the approval evaluation for pharmaceutical products. At the time of Citric Acid 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 Citric Acid suppliers with JDMF on PharmaCompass.
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