Indian Drug firm Zydus Cadila has received final approval from the US Food and Drug Administration (USFDA) to market Nateglinide tablets, used for treatment of diabetes, in the American market.
The approval allows Cadila to market Nateglinide tablets (USP), in the strengths of 60 mg and 120 mg, group firm Cadila Healthcare said in a BSE filing.
Nateglinide tables is an anti-diabetic agent used in the 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. The group has so far 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 at Rs 373.70 on BSE, up 14.40 points or 4.01 per cent from its previous closep.
Cadila Healthcare, meanwhile, received an Establishment Inspection Report (EIR) from the USFDA for its Moraiya manufacturing facility. This, however, only indicates closure of the inspection points (483s) raised based on the inspection carried out between 28 August 2014 and 5 September 2014. It does not in itself indicate resolution of the warning letter.
The company said it is in constant follow up with the USFDA for resolution of the warning letter.
Cadila Healthcare (CHL) is part of the Zydus Cadila Group. The company operates in areas of active pharmaceutical ingredients (API) to formulations, and animal health products to cosmeceuticals. Over the last five decades, it has been developing and manufacturing pharmaceutical products and selling and distributing these in over 50 countries around the world.