Drug firm Zydus Cadila has received final approval from the US health regulator to market amantadine tablets, used for the treatment of Parkinson’s disease and select viral infections, in the American market.
The group has received final approval from the US Food and Drug Administration (USFDA) to market Amantadine Hydrochloride Capsules USP, 100 mg, Zydus Cadila’s group firm Cadila Healthcare said in a BSE filing.
Amantadine Hydrochloride will be produced at the groups formulations manufacturing facility at Pharma SEZ in Ahmedabad.
Quoting IMS data as on April 2016, Zydus Cadila said Amantadine Hydrochloride had estimated sales of USD 40.1 million.
The Ahmedabad-based group now has more than 100 approvals from the USFDA. Till now, the group has filed over 270 abbreviated new drug applications (ANDAs) since it commenced filing process in 2003-04.
Shares of Cadila Healthcare, the groups listed entity, were trading 0.89 per cent up at Rs 339.15 on BSE in the afternoon session.