Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.
01 1Bal Pharma Limited
02 1Edmond Pharma s. r. l.
03 1Ohara Pharmaceutical Co., Ltd.
04 1Oril Industry
05 3Zhejiang Jiuzhou Pharmaceutical Co. , Ltd.
01 1GLICLAZIDE
02 5Gliclazide
03 1Japanese Pharmacopoeia gliclazide (production only)
01 3China
02 1France
03 1India
04 1Japan
05 1Sweden
Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.
Registration Number : 220MF10140
Registrant's Address : 5th Floor, Lakshminarayan Complex, 10/1, Palace Road, Bangalore-560052, India
Initial Date of Registration : 2008-06-10
Latest Date of Registration : 2008-06-10
Japanese Pharmacopoeia Gliclazide (for manufacturing only)
Registration Number : 226MF10188
Registrant's Address : 121-15 Toriiino, Koka-cho, Koka City, Shiga Prefecture
Initial Date of Registration : 2014-09-30
Latest Date of Registration : 2014-09-30
Registration Number : 221MF10193
Registrant's Address : Via G. B. Grassi 15-20157 Milano Italy
Initial Date of Registration : 2009-08-31
Latest Date of Registration : 2009-08-31
Registration Number : 217MF10332
Registrant's Address : 13, rue Auguste Desgene(') tais, 76210 Bolbec, FRANCE
Initial Date of Registration : 2005-08-09
Latest Date of Registration : 2018-04-09
Registration Number : 224MF10097
Registrant's Address : Waisha Road 99# Jiaojiang District Taizhou City Zhejiang Province China
Initial Date of Registration : 2012-05-08
Latest Date of Registration : 2012-05-08
Registration Number : 221MF10162
Registrant's Address : Waisha Road 99# Jiaojiang Taizhou City Zhejiang China
Initial Date of Registration : 2009-07-23
Latest Date of Registration : 2009-07-23
Registration Number : 227MF10100
Registrant's Address : Waisha Road 99# Jiaojiang Taizhou City, Zhejiang China
Initial Date of Registration : 2015-04-09
Latest Date of Registration : 2021-07-28
A Gliclazide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gliclazide, including repackagers and relabelers. The FDA regulates Gliclazide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gliclazide 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 Gliclazide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gliclazide supplier is an individual or a company that provides Gliclazide active pharmaceutical ingredient (API) or Gliclazide finished formulations upon request. The Gliclazide suppliers may include Gliclazide API manufacturers, exporters, distributors and traders.
click here to find a list of Gliclazide 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 Gliclazide Drug Master File in Japan (Gliclazide JDMF) empowers Gliclazide 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 Gliclazide JDMF during the approval evaluation for pharmaceutical products. At the time of Gliclazide 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 Gliclazide suppliers with JDMF on PharmaCompass.
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