01 1Dr. Paul Lohmann GmbH & Co. KGaA
01 1Sodium citrate hydrate
01 1Germany
Registration Number : 221MF10110
Registrant's Address : Hauptstrasse 2 D-31860 Emmerthal Germany
Initial Date of Registration : 2009-06-02
Latest Date of Registration : 2009-06-02
A Trisodium Citrate Dihydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trisodium Citrate Dihydrate, including repackagers and relabelers. The FDA regulates Trisodium Citrate Dihydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trisodium Citrate Dihydrate 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 Trisodium Citrate Dihydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Trisodium Citrate Dihydrate supplier is an individual or a company that provides Trisodium Citrate Dihydrate active pharmaceutical ingredient (API) or Trisodium Citrate Dihydrate finished formulations upon request. The Trisodium Citrate Dihydrate suppliers may include Trisodium Citrate Dihydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Trisodium Citrate Dihydrate 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 Trisodium Citrate Dihydrate Drug Master File in Japan (Trisodium Citrate Dihydrate JDMF) empowers Trisodium Citrate Dihydrate 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 Trisodium Citrate Dihydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Trisodium Citrate Dihydrate 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 Trisodium Citrate Dihydrate suppliers with JDMF on PharmaCompass.
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