Cadila Healthcare receives USFDA final nod for ursodiol capsules

The drug maker received final approval from US drug regulator for ursodiol capsules and tentative approval for linagliptin and metformin hydrochloride tablets.

Zydus Cadila has received final approval from the US Food and Drug Administration (USFDA) to market ursodiol capsules USP, 300 mg. Ursodiolis in a class of medications called gallstone dissolution agents. It is used to treat people with primary biliary cirrhosis (PBC; an autoimmune liver disease).

The company also received tentative approval from the USFDA to market linagliptin and metformin hydrochloride tabs in the strengths of 2.5 mg/500 mg, 2.5 mg/850 mg, and 2.5 mg/1,000 mg. It is used along with diet and exercise to improve control of blood sugar levels in adults with type 2 diabetes mellitus.

Both drugs will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad. The group now has 307 approvals and has so far filed over 390 ANDAs since the commencement of the filing process in FY 2003-04. The announcement was made on Saturday, 17 October 2020.

On a consolidated basis, Cadila Healthcare's net profit rose 49.3% to Rs 469.90 crore on 4.2% increase in net sales to Rs 3,549.30 crore in Q1 June 2020 over Q1 June 2019.

Cadila Healthcare is a global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies.

Shares of Cadila Healthcare rose 0.80% to Rs 434 on BSE. The scrip has grown 104.04% from its 52-week low of Rs 212.70 hit on 13 March 2020.

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