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
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PharmaCompass offers a list of Nortriptyline API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Nortriptyline manufacturer or Nortriptyline supplier for your needs.
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PharmaCompass also assists you with knowing the Nortriptyline API Price utilized in the formulation of products. Nortriptyline API Price is not always fixed or binding as the Nortriptyline Price is obtained through a variety of data sources. The Nortriptyline Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 00FN6IH15D manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 00FN6IH15D, including repackagers and relabelers. The FDA regulates 00FN6IH15D manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 00FN6IH15D API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A 00FN6IH15D supplier is an individual or a company that provides 00FN6IH15D active pharmaceutical ingredient (API) or 00FN6IH15D finished formulations upon request. The 00FN6IH15D suppliers may include 00FN6IH15D API manufacturers, exporters, distributors and traders.
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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 00FN6IH15D Drug Master File in Japan (00FN6IH15D JDMF) empowers 00FN6IH15D 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 00FN6IH15D JDMF during the approval evaluation for pharmaceutical products. At the time of 00FN6IH15D JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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