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