01 1Biocon Biologics Limited
01 1Insulin glargine (gene recombination)
01 1India
Insulin glargine (genetical recombination)
Registration Number : 226MF10213
Registrant's Address : Biocon House, Ground Floor, Tower-3, Semicon Park, Electronic City, Phase-II, Hosur R...
Initial Date of Registration : 2014-11-17
Latest Date of Registration : 2019-01-24
A Glargine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Glargine, including repackagers and relabelers. The FDA regulates Glargine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Glargine 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 Glargine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Glargine supplier is an individual or a company that provides Glargine active pharmaceutical ingredient (API) or Glargine finished formulations upon request. The Glargine suppliers may include Glargine API manufacturers, exporters, distributors and traders.
click here to find a list of Glargine 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 Glargine Drug Master File in Japan (Glargine JDMF) empowers Glargine 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 Glargine JDMF during the approval evaluation for pharmaceutical products. At the time of Glargine 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 Glargine suppliers with JDMF on PharmaCompass.
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