The clearance marks a major step in Diabeloop’s ambition to become a central partner for insulin pump manufacturers and expand access to automated insulin delivery in the US market
Afrezza comes in single-use cartridges, delivered via a simple inhaler device. Users select the appropriate cartridge, load it, inhale the insulin, and remove the cartridge
Over 100 million cartridges of rh-insulin supplied to Malaysian health ministry; 345,000+ patients served
The company was awarded the insulins supply contract for a three-year period in 2022 through April 2025
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
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