Zydus Cadila receives Final Approval from USFDA for Ursodiol Capsules and Tentative Approval for Linagliptin and Metformin Hydrochloride Tablets

Zydus Cadila has received final approval from the USFDA to market Ursodiol Capsules USP, 300 mg (US RLD: Actigall®Capsules). Ursodiol is 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 (US RLD: Jentadueto® Tablets) 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.

Shares of CADILA HEALTHCARE LTD. was last trading in BSE at Rs.430.55 as compared to the previous close of Rs. 415.6. The total number of shares traded during the day was 166413 in over 3239 trades.

The stock hit an intraday high of Rs. 432.2 and intraday low of 412. The net turnover during the day was Rs. 70759142.

Source : Equity Bulls

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