01 1Dr. Paul Lohmann GmbH & Co. KGaA
02 1Komatsuya Co., Ltd.
03 1Satsuma Chemical Co., Ltd.
01 2Japan Pharmaceutical Codex potassium citrate
02 1Potassium citrate
01 1Germany
02 2Japan
Registration Number : 221MF10109
Registrant's Address : Hauptstrasse 2 D-31860 Emmerthal Germany
Initial Date of Registration : 2009-06-02
Latest Date of Registration : 2009-06-02
Japanese Pharmacopoeia Non-Drug Standard Potassium Citrate
Registration Number : 219MF10180
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 Standard Potassium Citrate
Registration Number : 220MF10118
Registrant's Address : 1451 Kaseda Kawabata, Minamisatsuma City, Kagoshima Prefecture
Initial Date of Registration : 2008-04-28
Latest Date of Registration : 2008-04-28
A Potassium Citrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Potassium Citrate, including repackagers and relabelers. The FDA regulates Potassium Citrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Potassium Citrate 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 Potassium Citrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Potassium Citrate supplier is an individual or a company that provides Potassium Citrate active pharmaceutical ingredient (API) or Potassium Citrate finished formulations upon request. The Potassium Citrate suppliers may include Potassium Citrate API manufacturers, exporters, distributors and traders.
click here to find a list of Potassium Citrate 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 Potassium Citrate Drug Master File in Japan (Potassium Citrate JDMF) empowers Potassium Citrate 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 Potassium Citrate JDMF during the approval evaluation for pharmaceutical products. At the time of Potassium Citrate 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 Potassium Citrate suppliers with JDMF on PharmaCompass.
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