01 1Active Pharma Inc.
02 1Cheer Fine Pharmaceutical Co. , Ltd.
03 1Daiwa Pharmaceutical Industries Co., Ltd.
04 1RUYUAN HEC PHARM CO. , LTD.
01 2Outsiders regulations hydrochloric acid sultopride (production only)
02 1Sultopride Hydrochloride
03 1Sultopride hydrochloride
01 2China
02 1India
03 1Japan
Registration Number : 221MF10230
Registrant's Address : 8TH QingLuan Road. Economy and Technology Development Zone, Hefei, Anhui, China
Initial Date of Registration : 2009-10-26
Latest Date of Registration : 2009-10-26
Extramural regulation: Sultopride hydrochloride (for manufacturing only)
Registration Number : 217MF10498
Registrant's Address : 2-3-5 Shimookui, Toyama City, Toyama Prefecture
Initial Date of Registration : 2005-09-06
Latest Date of Registration : 2010-04-01
Registration Number : 303MF10003
Registrant's Address : Xiaba Development Zone, Ruyuan County, Shaoguan City, Guangdong Province, P. R. China
Initial Date of Registration : 2021-01-07
Latest Date of Registration : 2023-07-19
Extramural regulation: Sultopride hydrochloride (for manufacturing only)
Registration Number : 217MF10201
Registrant's Address : 2-36-1 Kanda Jinbocho, Chiyoda-ku, Tokyo
Initial Date of Registration : 2005-06-08
Latest Date of Registration : 2014-09-01
A Sultopride HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sultopride HCl, including repackagers and relabelers. The FDA regulates Sultopride HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sultopride HCl 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 Sultopride HCl supplier is an individual or a company that provides Sultopride HCl active pharmaceutical ingredient (API) or Sultopride HCl finished formulations upon request. The Sultopride HCl suppliers may include Sultopride HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Sultopride HCl 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 Sultopride HCl Drug Master File in Japan (Sultopride HCl JDMF) empowers Sultopride HCl 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 Sultopride HCl JDMF during the approval evaluation for pharmaceutical products. At the time of Sultopride HCl 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 Sultopride HCl suppliers with JDMF on PharmaCompass.
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