Zydus Cadila has received final approval from the US Food and Drug Administration (USFDA) to market Tranexamic acid injection in the strength of 1,000mg/10 mL (100mg/mL) single dose vial, Cadila Healthcare said in a BSE filing.
The product will be produced at the group's formulations manufacturing facility at Moraiya in Ahmedabad, it added.
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The injection is used to prevent or reduce bleeding in patients with hemophilia undergoing tooth extraction, the company said.
The Gujarat-based group has more than 130 approvals and has so far filed over 300 abbreviated new drug applications (ANDAs).
Shares of Cadila Healthcare, the listed entity of the Zydus group today closed 3.68 per cent higher at Rs 544.25 per scrip on BSE.