01 1Suven Pharmaceuticals Limited
01 1(R) - (-) - 5- (2- aminopropyl) -2-methoxybenzenesulfonamide hydrochloride (MAS HCl)
01 1India
(R)-(-)-5-(2-aminopropyl)-2-methoxybenzenesulfonamide hydrochloride (MAS HCl)
Registration Number : 223MF10025
Registrant's Address : SDE Serene Chambers, Road No5, Avenue #7 Banjara Hills, Hyderabad-500 034 Telangana, ...
Initial Date of Registration : 2011-02-17
Latest Date of Registration : 2016-09-09
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A Methoxybenzenesulfonamide Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Methoxybenzenesulfonamide Hydrochloride, including repackagers and relabelers. The FDA regulates Methoxybenzenesulfonamide Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Methoxybenzenesulfonamide 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.
A Methoxybenzenesulfonamide Hydrochloride supplier is an individual or a company that provides Methoxybenzenesulfonamide Hydrochloride active pharmaceutical ingredient (API) or Methoxybenzenesulfonamide Hydrochloride finished formulations upon request. The Methoxybenzenesulfonamide Hydrochloride suppliers may include Methoxybenzenesulfonamide Hydrochloride 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 Methoxybenzenesulfonamide Hydrochloride Drug Master File in Japan (Methoxybenzenesulfonamide Hydrochloride JDMF) empowers Methoxybenzenesulfonamide 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 Methoxybenzenesulfonamide Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Methoxybenzenesulfonamide Hydrochloride 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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