Zydus Cadila gets USFDA nod for anti-diabetics tablets
Drug firm Zydus Cadila has received final nod from the US health regulator to sell anti-diabetics Glyburide and Metformin Hcl tablets in the American market.
New Delhi: Drug firm Zydus Cadila has received final nod from the US health regulator to sell anti-diabetics Glyburide and Metformin Hcl tablets in the American market.
"Zydus Cadila has received the final approval from the United States Food and Drug Administration (USFDA) to market Glyburide and Metformin Hcl tablets USP in strengths of 1.25/250, 2.5/500 and 5/500 mg," Cadila Healthcare said in a BSE filing.
The drug falls in the anti-diabetics segment and the group's formulations manufacturing site at Baddi will be producing the drug for the US market, it added.
"The group now has 103 approvals and has so far filed over 280 abbreviated new drug applications (ANDAs) since the commencement of the filing process in FY 2003-04, Cadila Healthcare said.
Shares of Cadila Healthcare were trading at Rs 321.90 in the afternoon trade on BSE, up 2.26 percent from the previous close