Cadila Healthcare today said that Zydus Cadila has received final approval from the US health regulator to market Lansoprazole capsules used for treating ulcers and other conditions involving excessive stomach acid.
“Zydus Cadila has received the final approval from the United States Food and Drug Administration (USFDA) to market Lansoprazole delayed release capsules in different strengths of 15 mg and 30 mg,” Cadila Healthcare said in a filing to the BSE.
The product had estimated sales of $501 million in 2012, as per the IMS Health data.
“The group now has 81 approvals and has so far filed 186 abbreviated new drug applications (ANDAs) since the commencement of filing process in FY’2003-2004,” Cadila Healthcare said.
The Ahmedabad-based firm has global operations spread across the US, Europe, Japan, Brazil, South Africa and 25 other emerging markets.
Shares of Cadila Healthcare were today trading at Rs 654.50 per scrip on the BSE, up 1.32 per cent from their previous close.