01 2Cheer Fine Pharmaceutical Co. , Ltd.
02 1Daiwa Pharmaceutical Industries Co., Ltd.
03 1IcromS. r. l.
01 1Japan Bureau Sulpiride (for manufacturing only)
02 1Japanese Pharmacopoeia Drug sulpiride (production only)
03 1SULPIRIDE
04 1SULPIRIDE JP
01 2China
02 1India
03 1Italy
Registration Number : 220MF10210
Registrant's Address : No. 2066 Tangkou Road, Economy and Technology Development Zone, Hefei, Anhui Province...
Initial Date of Registration : 2008-09-30
Latest Date of Registration : 2008-10-17
Registration Number : 229MF10008
Registrant's Address : No. 2066 Tangkou Road, Economy and Technology Development Zone, Hefei, Anhui Province...
Initial Date of Registration : 2017-01-10
Latest Date of Registration : 2017-01-10
Japanese Pharmacopoeia Drug Sulpiride (for manufacturing only)
Registration Number : 217MF10507
Registrant's Address : 2-3-5 Shimookui, Toyama City, Toyama Prefecture
Initial Date of Registration : 2005-09-06
Latest Date of Registration : 2007-04-27
JP Sulpiride (for manufacturing purposes only)
Registration Number : 218MF10084
Registrant's Address : Via Delle Arti 33, 20863 Concorezzo (MB), Italy
Initial Date of Registration : 2006-01-27
Latest Date of Registration : 2018-10-23
A Espiride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Espiride, including repackagers and relabelers. The FDA regulates Espiride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Espiride 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 Espiride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Espiride supplier is an individual or a company that provides Espiride active pharmaceutical ingredient (API) or Espiride finished formulations upon request. The Espiride suppliers may include Espiride API manufacturers, exporters, distributors and traders.
click here to find a list of Espiride 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 Espiride Drug Master File in Japan (Espiride JDMF) empowers Espiride 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 Espiride JDMF during the approval evaluation for pharmaceutical products. At the time of Espiride 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 Espiride suppliers with JDMF on PharmaCompass.
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