New Delhi : Drug firm Zydus Cadila has received approval from the USFDA to market tizanidine hydrochloride capsules, a muscle relaxant, in the American market.
“The company has received final approval from the US Food and Drug Administration (USFDA) to market tizanidine hydrochloride capsules, USP in strengths of 2mg, 4mg and 6mg,” Zydus Cadila said in a regulatory filing.
The drug will be produced at the group’s manufacturing SEZ facility in Ahmedabad.
Quoting IMS January 2017 data, the company said tizanidine hydrochloride capsules’ estimated sales stood at USD 58.6 million.
The Gujarat-based group now has more than 110 approvals and has so far filed nearly 300 abbreviated new drug applications (ANDAs) since 2003-04.
Shares of Cadila Healthcare, the group’s listed entity, were trading at Rs 437.95 apiece on BSE, up 0.52 per cent, its previous close.