01 2Eli Lilly and Company
02 3Lilly del Caribe, Inc.
01 1Insulin lispro (genetical recombination)
02 4Insulin lispro (recombinant)
01 5U.S.A
Insulin Lispro (genetical recombination)
Registration Number : 303MF10175
Registrant's Address : 65th Infantry Road, Km. 12.6, Carolina, Puerto Rico 00985
Initial Date of Registration : 2021-12-09
Latest Date of Registration : 2021-12-09
Insulin Lispro (genetical recombination)
Registration Number : 229MF10064
Registrant's Address : 65th Infantry Road, Km. 12.6, Carolina, Puerto Rico 00985
Initial Date of Registration : 2017-03-13
Latest Date of Registration : 2017-12-25
Insulin Lispro (genetical recombination)
Registration Number : 226MF10225
Registrant's Address : Lilly Corporate Center, Indianapolis, Indiana 46285, USA
Initial Date of Registration : 2014-12-08
Latest Date of Registration : 2017-12-25
Insulin Lispro (genetical recombination)
Registration Number : 219MF10053
Registrant's Address : 65th Infantry Road, Km. 12.6, Carolina, Puerto Rico 00985
Initial Date of Registration : 2007-03-05
Latest Date of Registration : 2017-12-25
Insulin Lispro (genetical recombination)
Registration Number : 217MF10534
Registrant's Address : Lilly Corporate Center, Indianapolis, Indiana 46285, USA
Initial Date of Registration : 2005-09-09
Latest Date of Registration : 2017-12-25
A Humalog manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Humalog, including repackagers and relabelers. The FDA regulates Humalog manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Humalog 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 Humalog manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Humalog supplier is an individual or a company that provides Humalog active pharmaceutical ingredient (API) or Humalog finished formulations upon request. The Humalog suppliers may include Humalog API manufacturers, exporters, distributors and traders.
click here to find a list of Humalog 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 Humalog Drug Master File in Japan (Humalog JDMF) empowers Humalog 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 Humalog JDMF during the approval evaluation for pharmaceutical products. At the time of Humalog 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 Humalog suppliers with JDMF on PharmaCompass.
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