News | March 07, 2025
Biocon Biologics and Civica collaborate to expand Insulin Aspart access in US
There are 38.4 million people with diabetes in the United States
There are 38.4 million people with diabetes in the United States
The huminsulin range of products is indicated for the treatment of type 1 and type 2 diabetes mellitus to improve blood sugar control in both adults and childre
Afrezza, developed by MannKind Corporation in the USA, offers a needle-free, rapid-acting insulin option for diabetes management
The market size of Aspart in India is currently estimated over Rs. 260 crore with only 2 players
The inspection concluded with the issuance of a form 483 with five observations
The company had submitted a comprehensive Corrective and Preventive Action (CAPA) plan in September 2022
The agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories
The CRL did not identify any outstanding scientific issues with the product.
The company has received the Certificate of GMP Compliance from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland.
India has the second-largest number of adults with diabetes globally, after China
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