Zydus gets US FDA approval for telmisartan & hydrochlorothiazide tablets to treat hypertension
Zydus Cadila has received the final approval from the US FDA to market telmisartan and hydrochlorothiazide tablets USP, in the strengths of 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg.
Telmisartan and hydrochlorothiazide tablets are used to treat hypertension (high blood pressure). The drug will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad.
According to IMS National Sales Perspective Audit, MAT June 2017, the sales of telmisartan and hydrochlorothiazide tablets is estimated at $66.5 million.
The group now has more than 140 approvals and has so far filed over 300 ANDAs since the commencement of the filing process in FY 2003-04.