01 1Active Pharma Inc.
01 1Perospirone hydrochloride hydrate
01 1Japan
Perospirone hydrochloride hydrate
Registration Number : 222MF10108
Registrant's Address : 2-36-1 Kanda Jinbocho, Chiyoda-ku, Tokyo
Initial Date of Registration : 2010-03-23
Latest Date of Registration : 2018-05-21
A Perospirone Hydrochloride Hydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Perospirone Hydrochloride Hydrate, including repackagers and relabelers. The FDA regulates Perospirone Hydrochloride Hydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Perospirone Hydrochloride Hydrate 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 Perospirone Hydrochloride Hydrate supplier is an individual or a company that provides Perospirone Hydrochloride Hydrate active pharmaceutical ingredient (API) or Perospirone Hydrochloride Hydrate finished formulations upon request. The Perospirone Hydrochloride Hydrate suppliers may include Perospirone Hydrochloride Hydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Perospirone Hydrochloride Hydrate 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 Perospirone Hydrochloride Hydrate Drug Master File in Japan (Perospirone Hydrochloride Hydrate JDMF) empowers Perospirone Hydrochloride Hydrate 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 Perospirone Hydrochloride Hydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Perospirone Hydrochloride Hydrate 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 Perospirone Hydrochloride Hydrate suppliers with JDMF on PharmaCompass.
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