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