EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
01 1EUROAPI Hungary Ltd.
02 1Dipharma Francis S. r. l.
01 2Selegiline hydrochloride
01 1France
02 1Italy
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Registration Number : 229MF10114
Registrant's Address : To(´) utca 1-5. , 1045 Budapest, Hungary
Initial Date of Registration : 2017-06-30
Latest Date of Registration : 2017-06-30
Registration Number : 219MF10340
Registrant's Address : Via Bissone, 5, 20021-Baranzate, Milano, Italy
Initial Date of Registration : 2007-11-21
Latest Date of Registration : 2023-06-07
A Selegiline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Selegiline, including repackagers and relabelers. The FDA regulates Selegiline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Selegiline 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 Selegiline manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Selegiline supplier is an individual or a company that provides Selegiline active pharmaceutical ingredient (API) or Selegiline finished formulations upon request. The Selegiline suppliers may include Selegiline API manufacturers, exporters, distributors and traders.
click here to find a list of Selegiline 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 Selegiline Drug Master File in Japan (Selegiline JDMF) empowers Selegiline 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 Selegiline JDMF during the approval evaluation for pharmaceutical products. At the time of Selegiline 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 Selegiline suppliers with JDMF on PharmaCompass.
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