Zydus Cadila has received final approval from the US health regulator to market Telmisartan and Hydrochlorothiazide tablets used in the treatment of hypertension.
The company has received final approval from the US Food and Drug Administration (USFDA) to market the drug in the strengths of 40 mg/12.5 mg, 80 mg/25 mg, Zydus Cadila said in a BSE filing today.
The company will manufacture the drug at its formulations manufacturing facility in Moraiya, Ahmedabad.
Quoting IMS June 2017 data, the company said the total sales of Telmisartan and Hydrochlorothiazide tablets is estimated at $66.5 million.
The company has more than 140 approvals and has so far filed over 300 abbreviated new drug applications (ANDAs) since it had commenced filings in 2003-04.
Shares of the company’s listed entity Cadila Healthcare were trading down by 0.23 per cent at Rs 482.50 on the BSE.