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