The final approval from the United States Food and Drug Administration (USFDA) is to market Lansoprazole delayed release orally disintegrating tablets in the strengths of 15 mg and 30 mg, Zydus Cadila said in a statement.
The product "will be manufactured at the group's formulations manufacturing facility at Moraiya, Ahmedabad," it added.
The company has also received tentative approval from the USFDA for generic Linagliptin tablets in the strength of 5 mg, it added.
Linagliptin tablets will be manufactured at the group's formulations manufacturing facility at SEZ, Ahmedabad, Zydus Cadila said.
The product is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, it added.
The group now has 236 approvals and has so far filed over 340 abbreviated new drug applications (ANDAs) since the commencement of its filing process, Zydus Cadila said.
Shares of Cadila Healthcare, the listed entity of the group, were trading at Rs 347.50 per scrip on the BSE, up 1.39 per cent from their previous close.
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