Biocon Gets DCGI Nod For Liraglutide Drug Substance, Product

Biocon Ltd. on Monday said it has received approval from the Drugs Controller General of India for its Liraglutide drug substance. Its wholly-owned arm, Biocon Pharma Ltd., also secured approval for the 6 ml solution form of the drug product for injection in a pre-filled pen and cartridge.

Liraglutide is the generic version of Victoza and is used to treat insufficiently controlled Type 2 Diabetes Mellitus in adults, adolescents, and children over 10 years as an add-on to diet and exercise.

The approval was granted under the 101 route, which recognises clearances from established global regulators. The company said it is preparing to launch the product in India through commercial partners.