Biocon arm Biocon Pharma secures US FDA nod for generic Liraglutide injection gVictoza

Biotechnology major Biocon Ltd on Thursday (March 12) said its wholly owned subsidiary, Biocon Pharma Ltd, has received approval from the US Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Liraglutide Injection (gVictoza), 18 mg/3 mL (6 mg/mL), in single-patient-use prefilled pens.

Liraglutide is indicated for the treatment of insufficiently controlled Type 2 Diabetes Mellitus in adults, adolescents and children aged 10 years and above, and is used as an adjunct to diet and exercise.

The approval follows the US FDA’s earlier clearance for Liraglutide injection (gSaxenda) that the company received on February 24, 2026. Biocon said the latest approval adds to its portfolio of vertically integrated, complex drug products.

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Last week, Biocon said it has completed the acquisition of Optionally Convertible Redeemable Non-Cumulative Preference Shares (OCRPS) of its wholly owned subsidiaries. The company acquired 11.53 crore OCRPS of ₹10 each of Biocon Biosphere Ltd at a total cost of ₹115.34 crore, comprising ₹20 crore in cash and ₹95.34 crore, including earlier loans and accrued interest.

Biocon Biosphere, incorporated in 2019, manufactures APIs and generic formulations through its greenfield facilities in Vizag and Bengaluru. Its turnover for FY24-25 was ₹13 crore. Biocon also acquired 20 crore OCRPS of ₹10 each of Biocon Pharma Ltd at a cost of ₹200 crore in cash.

Biocon Pharma, incorporated in 2014, develops and manufactures generic formulations for global markets, including the US and Europe, with an oral solid dosage facility in Bengaluru. Its turnover for FY24-25 was ₹982.5 crore.

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Both transactions are related-party transactions as they involve wholly owned subsidiaries, but are exempt under SEBI Listing Regulations. The investments are intended to support ongoing business requirements, including working capital, capex, and general corporate needs. Following the acquisition, Biocon holds 100% of the paid-up share capital, including equity shares and OCRPS, of both subsidiaries.

Shares of Biocon Ltd ended at ₹392.70, down by ₹2.65, or 0.67%, on the BSE.