"Zydus Cadila has received tentative approval from the United States Food and Drug Administration (USFDA) to market Glipizide extended release tablets in the strengths of 2.5 mg, 5 mg and 10 mg," Zydus group's listed entity, Cadila Healthcare, said in a filing to BSE.
According to IMS Health, the estimated sales in 2014 for Glipizide ER tablets is $90.1 million.
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"The group now has 97 approvals and has so far filed 249 abbreviated new drug applications (ANDAs) since the commencement of the filing process in 2003-2004," Cadila Healthcare said.
Shares of Cadila Healthcare were trading 0.30% up at Rs 1,291.20 per scrip in the afternoon on the BSE.
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