01 1piCHEM Forschungs- und Entwicklungs GmbH
01 1Daughter Octreotate (trifluoroacetic acid salt)
01 1Austria
Registration Number : 303MF10074
Registrant's Address : Parkring 3, 8074 Raaba-Grambach, Austria
Initial Date of Registration : 2021-04-27
Latest Date of Registration : 2022-08-03
A Trifluoroacetic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trifluoroacetic Acid, including repackagers and relabelers. The FDA regulates Trifluoroacetic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trifluoroacetic 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 Trifluoroacetic Acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Trifluoroacetic Acid supplier is an individual or a company that provides Trifluoroacetic Acid active pharmaceutical ingredient (API) or Trifluoroacetic Acid finished formulations upon request. The Trifluoroacetic Acid suppliers may include Trifluoroacetic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Trifluoroacetic 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 Trifluoroacetic Acid Drug Master File in Japan (Trifluoroacetic Acid JDMF) empowers Trifluoroacetic 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 Trifluoroacetic Acid JDMF during the approval evaluation for pharmaceutical products. At the time of Trifluoroacetic 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 Trifluoroacetic Acid suppliers with JDMF on PharmaCompass.
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