The company has received final approval from the US Food and Drug Administration (USFDA) to market entecavir tablets in the strengths of 0.5 mg and 1 mg, Zydus Cadila said in a statement.
The drug will be produced at the group's formulations manufacturing facility at the Pharma SEZ in Ahmedabad. As per IMS MAT April data, estimated sales for entecavir tablets stood at USD 166.3 million.
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The Ahmedabad-based group has now more than 120 approvals from the USFDA and has so far filed over 300 abbreviated new drug applications (ANDA) since the commencement of the filing process in FY 2003-04.
Shares of Cadila Healthcare, the group's listed entity, today ended marginally up at Rs 525 on the BSE.
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