"We received the US regulator's acceptance of our subsidiary's application to sell the two generic therapy drugs in the American market," said the city-based company in a statement here.
The Singapore-based subsidiary Strides Pharma Global Pte Ltd of Strides Pharma Science Ltd filed an Abbreviated New Drug Application (ANDA) for a US generic drug approval.
The regulatory approval will allow Strides arm to market the drugs as a safe, effective, low-cost alternative to the American public.
The US market for the two drugs is estimated to be $550 million (Rs 3,823 crore).
"The watchdog also granted Strides' request to designate the drugs as a competitive generic therapy," said the statement.
With the new section 506H of the Food, Drug, and Cosmetic Act, a drug is eligible for designation as a competitive generic therapy if the regulator determines that there is "inadequate generic competition".
(This story has not been edited by Social News XYZ staff and is auto-generated from a syndicated feed.)
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