01 1Dipharma Francis S. r. l.
01 1Nortriptyline hydrochloride
01 1Italy
Registration Number : 219MF10264
Registrant's Address : Via Bissone, 5, 20021-Baranzate, Milano, Italy
Initial Date of Registration : 2007-08-16
Latest Date of Registration : 2021-05-24
A Nortriptyline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nortriptyline, including repackagers and relabelers. The FDA regulates Nortriptyline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nortriptyline 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 Nortriptyline manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nortriptyline supplier is an individual or a company that provides Nortriptyline active pharmaceutical ingredient (API) or Nortriptyline finished formulations upon request. The Nortriptyline suppliers may include Nortriptyline API manufacturers, exporters, distributors and traders.
click here to find a list of Nortriptyline 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 Nortriptyline Drug Master File in Japan (Nortriptyline JDMF) empowers Nortriptyline 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 Nortriptyline JDMF during the approval evaluation for pharmaceutical products. At the time of Nortriptyline 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 Nortriptyline suppliers with JDMF on PharmaCompass.
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