
Biocon gets CDSCO approval for Liraglutide drug substance
Biocon said that it has received an approval from the Drugs Controller General of India (DCGI), under the central drugs standard control organisation (CDSCO), for its Liraglutide drug substance.
Additionally, its wholly owned subsidiary, Biocon Pharma, has received CDSCO approval for the Liraglutide drug product (6 mg/ml solution for injection in pre-filled pen and cartridge).
The said approval is for the generic version of Victoza, indicated for the treatment of insufficiently controlled type 2 diabetes mellitus in adults, adolescents and children aged 10 years and above, as an adjunct to diet and exercise. The approval was received from the CDSCO under the recently formulated 101 route that enables recognition of approvals granted by established and referenced serious regulatory authorities.
Siddharth Mittal, chief executive officer and managing director, Biocon, said: The approval of our first vertically integrated GLP-1 in India, Liraglutide, is another significant step forward in expanding access of this product to patients suffering from diabetes. India has one of the highest number of people with diabetes globally, with estimates exceeding 77 million cases, and expected to rise further. The approval enables us to address a critical need by making this drug available, and aligns with Biocons mission to provide affordable, lifesaving medications to those who need it the most. We are now gearing up to launch the product expeditiously through our commercialization partners in India.
Biocon is an innovation-led global biopharmaceutical company focused on improving affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune diseases. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets, as well as generic formulations in the U.S. and Europe
The companys consolidated net profit surged 154.2% to Rs 344.50 crore on 12.8% jump in net sales to Rs 4,358.10 crore in Q4 FY25 over Q4 FY24.
The counter shed 0.45% to end at Rs 334.05 on the BSE.
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