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Zydus Cadila gets USFDA’s nod for Ambrisentan Tablets

29 Mar 2019 Evaluate

Zydus Cadila has received the final approval from the United States Food & Drug Administration (USFDA) to market Ambrisentan Tablets USP (US RLD-Letairis Tablets), 5 mg and 10 mg. It is used to treat high blood pressure in the lungs (pulmonary arterial hypertension) and will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. The US sales of Ambrisentan Tablets USP stood at $943 million in 2018.

The group now has 258 approvals and has so far filed over 350 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies.

Peers
Company Name CMP
Sun Pharma. Inds. 1864.00
Dr. Reddys Labs. 1140.80
Cipla 1380.00
Lupin 2075.00
Zydus Lifesciences 1118.00
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