01 1Assia Chemical Industries Ltd.
01 1Modafinil "Teva"
01 1Israel
Registration Number : 227MF10270
Registrant's Address : Neot-Hovav Eco-Industrial Park, Emek Sara P. O. Box 2049 Be'er Sheva 8412316, Israel
Initial Date of Registration : 2015-11-19
Latest Date of Registration : 2023-07-19
A Modafinil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Modafinil, including repackagers and relabelers. The FDA regulates Modafinil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Modafinil 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 Modafinil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Modafinil supplier is an individual or a company that provides Modafinil active pharmaceutical ingredient (API) or Modafinil finished formulations upon request. The Modafinil suppliers may include Modafinil API manufacturers, exporters, distributors and traders.
click here to find a list of Modafinil 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 Modafinil Drug Master File in Japan (Modafinil JDMF) empowers Modafinil 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 Modafinil JDMF during the approval evaluation for pharmaceutical products. At the time of Modafinil 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 Modafinil suppliers with JDMF on PharmaCompass.
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