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
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PharmaCompass offers a list of Glibenclamide API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Glibenclamide manufacturer or Glibenclamide supplier for your needs.
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PharmaCompass also assists you with knowing the Glibenclamide API Price utilized in the formulation of products. Glibenclamide API Price is not always fixed or binding as the Glibenclamide Price is obtained through a variety of data sources. The Glibenclamide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Renabetic manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Renabetic, including repackagers and relabelers. The FDA regulates Renabetic manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Renabetic API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Renabetic supplier is an individual or a company that provides Renabetic active pharmaceutical ingredient (API) or Renabetic finished formulations upon request. The Renabetic suppliers may include Renabetic API manufacturers, exporters, distributors and traders.
click here to find a list of Renabetic 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 Renabetic Drug Master File in Japan (Renabetic JDMF) empowers Renabetic 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 Renabetic JDMF during the approval evaluation for pharmaceutical products. At the time of Renabetic 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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