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01 1EUROAPI Hungary Ltd.
02 1Dipharma Francis S. r. l.
01 2Selegiline hydrochloride
01 1France
02 1Italy
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 Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Selegiline Hydrochloride, including repackagers and relabelers. The FDA regulates Selegiline Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Selegiline Hydrochloride 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 Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Selegiline Hydrochloride supplier is an individual or a company that provides Selegiline Hydrochloride active pharmaceutical ingredient (API) or Selegiline Hydrochloride finished formulations upon request. The Selegiline Hydrochloride suppliers may include Selegiline Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Selegiline Hydrochloride 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 Hydrochloride Drug Master File in Japan (Selegiline Hydrochloride JDMF) empowers Selegiline Hydrochloride 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 Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Selegiline Hydrochloride 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 Hydrochloride suppliers with JDMF on PharmaCompass.
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