Zydus Cadila announced the Day 1 launch of Tadalafil Tablets USP (US RLD – Cialis Tablets) upon receiving the final approval from the US FDA for marketing the product in the strengths of 2.5 mg, 5 mg, 10 mg, and 20 mg. Manufactured at the group’s manufacturing facility at Moraiya, Ahmedabad, the drug is used to treat erectile dysfunction (impotence) and symptoms of benign prostatic hypertrophy (enlarged prostate). The sales of Tadalafil Tablets USP in the US stood at $1.73 billion. (As per IQVIA, National Sales Perspective Audit, MAT January 2019) The group now has 257 approvals and has so far filed over 350 ANDAs since the commencement of the filing process in FY 2003-04.
Zydus receives final approval from the USFDA for Ambrisentan Tablets
Zydus Cadila has received the final approval from the 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.