Shares of Biocon Ltd gained 1% on 28 August after the company announced securing USFDA approval for Sitagliptin Tablets. 

In its regulatory filing, the company said that Biocon Pharma Limited, a wholly-owned subsidiary of the company, has received preliminary approval from the United States Food and Drug Administration (US FDA) for its abbreviated new drug application (ANDA) for Sitagliptin Tablets USP in 25 mg, 50 mg, and 100 mg strengths.

Sitagliptin pills are used as a supplement to diet and exercise to enhance glycemic control in persons with type 2 diabetes. The approval will improve Biocon’s range of vertically integrated medicinal products, according to a BSE filing.

Earlier, in July, Biocon Biologics Ltd gained FDA approval for Kirsty (Insulin Aspart-xjhz), 100 units/mL, as the first and only interchangeable biosimilar to NovoLog (Insulin Aspart).

KIRSTY is a rapid-acting human insulin analogue that is used to improve glycemic control in adults and children with diabetes.

Biocon Biologics increases its biosimilar insulin line with the USFDA approval of Kirsty.
Extending its diabetes portfolio, in June, Biocon received approval in India for its Liraglutide drug substance, and its wholly owned subsidiary, Biocon Pharma Limited, received approval from the Drugs Controller General of India, CDSCO (Central Drugs Standard Control Organisation), for its Liraglutide drug product (6 mg/ml solution for injection in pre-filled pen and cartridge).

The CDSCO provided clearance via the recently developed 101 route, which allows for the recognition of approvals obtained by established and recognised significant regulatory authorities. Liraglutide is a synthetic version of the GLP-1 peptide that is given as a once-a-day injection.

CDSCO approves Biocon diabetes medication.  Liraglutide Biocon Limited, which went public in 2004, is a biopharmaceutical firm that operates globally. It has created and marketed new biologics, biosimilars, and complicated small molecule APIs in India and other significant worldwide markets, as well as generic formulations in the United States and Europe.

However, at 1:23 pm, the shares of Biocon were trading 0.52% lower at Rs 356.45 on NSE.

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