01 1Phospholipid GmbH
01 1Phosphatidylcholine (ethanol solution)
01 1Germany
Phosphatidylcholine (ethanol solution)
Registration Number : 229MF10002
Registrant's Address : Nattermannallee 1, D-50829 Cologne, Germany
Initial Date of Registration : 2017-01-10
Latest Date of Registration : 2017-01-10
A Phosphatidylcholines manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Phosphatidylcholines, including repackagers and relabelers. The FDA regulates Phosphatidylcholines manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Phosphatidylcholines 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 Phosphatidylcholines manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Phosphatidylcholines supplier is an individual or a company that provides Phosphatidylcholines active pharmaceutical ingredient (API) or Phosphatidylcholines finished formulations upon request. The Phosphatidylcholines suppliers may include Phosphatidylcholines API manufacturers, exporters, distributors and traders.
click here to find a list of Phosphatidylcholines 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 Phosphatidylcholines Drug Master File in Japan (Phosphatidylcholines JDMF) empowers Phosphatidylcholines 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 Phosphatidylcholines JDMF during the approval evaluation for pharmaceutical products. At the time of Phosphatidylcholines 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 Phosphatidylcholines suppliers with JDMF on PharmaCompass.
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