Drug firm Zydus Cadila today said it has received final approval from the US health regulator to market anti-diabetic Glyburide tablets in the American market.
The group has received final approval from the US Food and Drug Administration (USFDA) to market the drug in strengths of 1.25, 2.5 and 5 mg, Zydus Cadila said in a statement.
Glyburide will be produced at the group’s formulations manufacturing facility at Baddi (Himachal Pradesh).
The Ahmedabad-based group now has more than 100 approvals from the USFDA. Till now the group has filed over 280 abbreviated new drug applications (ANDAs) since it commenced filing process in 2003-04.
Shares of Cadila Healthcare, the group’s listed entity, were trading 0.23 per cent up at Rs 334.05 apiece on BSE.