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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A A19539 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of A19539, including repackagers and relabelers. The FDA regulates A19539 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. A19539 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 A19539 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A A19539 supplier is an individual or a company that provides A19539 active pharmaceutical ingredient (API) or A19539 finished formulations upon request. The A19539 suppliers may include A19539 API manufacturers, exporters, distributors and traders.
click here to find a list of A19539 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 A19539 Drug Master File in Japan (A19539 JDMF) empowers A19539 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 A19539 JDMF during the approval evaluation for pharmaceutical products. At the time of A19539 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 A19539 suppliers with JDMF on PharmaCompass.
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