New Delhi : Drug firm Zydus Cadila has received final approval from the US health regulator to market Nateglinide tablets, used for treatment of diabetes, in the American market.
Zydus Cadila has received final approval from the US Food and Drug Administration (USFDA) to market Nateglinide tablets tablets USP, in the strengths of 60 mg and 120 mg, Zydus Cadila’s group firm Cadila Healthcare said in a BSE filing.
Nateglinide tables is an anti-diabetic agent used in management of type-2 diabetes mellitus and will be produced at the group’s formulation manufacturing facility at Pharma SEZ in Ahmedabad.
The Ahmedabad based group now has more than 100 approvals from USFDA. Till now, the group has filed over 270 abbreviated new drug applications (ANDAs) since it commenced filing process in 2003-04.
Cadila Healthcare, the group’s listed entity, was trading 4.01 per cent up at Rs 373.70 on BSE.