01 2CADILA PHARMACEUTICALS LIMITED.
02 1Cambrex Profarmaco Milano S. r. l.
03 1Dipharma Francis S. r. l.
01 3Glibenclamide
02 1Glibenclamide (production only)
01 2India
02 1Italy
03 1U.S.A
Glibenclamide (for manufacturing purposes only)
Registration Number : 218MF10993
Registrant's Address : Sarkhej-Dholka Road, Bhat, Ahmedabad-382 210, Gujarat, INDIA
Initial Date of Registration : 2006-12-18
Latest Date of Registration : 2018-12-11
Registration Number : 301MF10082
Registrant's Address : Sarkhej-Dholka Road, Bhat, Ahmedabad-382 210, Gujarat, INDIA
Initial Date of Registration : 2019-10-25
Latest Date of Registration : 2019-10-25
Registration Number : 302MF10129
Registrant's Address : Via Curiel 34, 20067 Paulo, Milano, ITALY
Initial Date of Registration : 2020-10-21
Latest Date of Registration : 2020-10-21
Registration Number : 224MF10231
Registrant's Address : Via Bissone, 5, 20021-Baranzate, Milano, Italy
Initial Date of Registration : 2012-12-18
Latest Date of Registration : 2022-08-24
A Glibenclamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Glibenclamide, including repackagers and relabelers. The FDA regulates Glibenclamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Glibenclamide 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 Glibenclamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Glibenclamide supplier is an individual or a company that provides Glibenclamide active pharmaceutical ingredient (API) or Glibenclamide finished formulations upon request. The Glibenclamide suppliers may include Glibenclamide API manufacturers, exporters, distributors and traders.
click here to find a list of Glibenclamide 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 Glibenclamide Drug Master File in Japan (Glibenclamide JDMF) empowers Glibenclamide 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 Glibenclamide JDMF during the approval evaluation for pharmaceutical products. At the time of Glibenclamide 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 Glibenclamide suppliers with JDMF on PharmaCompass.
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