This approval builds on company’s successful track record of bringing the first interchangeable insulin, Semglee.
Lupin said the business is thoroughly reviewing the findings and would respond to the USFDA within the timeframe specified.
Alembic plans to invest ₹550-₹600 Crore on R&D in FY25, focusing on creating a pipeline of medicines for the US market.
Cipla primarily develops drugs to treat respiratory disease, cardiovascular disease, arthritis, diabetes, depression, etc.
During the quarter, Mankind introduced four new drugs in the United States, bringing the total number of launched items to 39.
The partnership follows Biocon's success in becoming the first business to receive approval for gLiraglutide in an ICH country.
Its interest revenue increased by 55% year on year to ₹492 Crore from ₹318 Crore in FY24, while assets under management increased by 34% to ₹10,593 Crore.
With the acquisition of Medica, Manipal facilities now serve 7 million patients yearly across 37 facilities in 19 cities throughout 14 states.
Suresh Narayanan, chairman and managing director of Nestlé India, expressed that this collaboration will empower them to develop a strong retail and distribution infrastructure.
The USFDA also noted the company’s commitment to temporarily halt the production of all drugs made on both dedicated and non-dedicated equipment.
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