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
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PharmaCompass offers a list of Insulin Glargine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Insulin Glargine manufacturer or Insulin Glargine supplier for your needs.
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PharmaCompass also assists you with knowing the Insulin Glargine API Price utilized in the formulation of products. Insulin Glargine API Price is not always fixed or binding as the Insulin Glargine Price is obtained through a variety of data sources. The Insulin Glargine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A A21-Gly-B31-Arg-B32-Arg-insulin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of A21-Gly-B31-Arg-B32-Arg-insulin, including repackagers and relabelers. The FDA regulates A21-Gly-B31-Arg-B32-Arg-insulin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. A21-Gly-B31-Arg-B32-Arg-insulin 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 A21-Gly-B31-Arg-B32-Arg-insulin supplier is an individual or a company that provides A21-Gly-B31-Arg-B32-Arg-insulin active pharmaceutical ingredient (API) or A21-Gly-B31-Arg-B32-Arg-insulin finished formulations upon request. The A21-Gly-B31-Arg-B32-Arg-insulin suppliers may include A21-Gly-B31-Arg-B32-Arg-insulin API manufacturers, exporters, distributors and traders.
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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 A21-Gly-B31-Arg-B32-Arg-insulin Drug Master File in Japan (A21-Gly-B31-Arg-B32-Arg-insulin JDMF) empowers A21-Gly-B31-Arg-B32-Arg-insulin 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 A21-Gly-B31-Arg-B32-Arg-insulin JDMF during the approval evaluation for pharmaceutical products. At the time of A21-Gly-B31-Arg-B32-Arg-insulin JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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