Zydus Pharmaceuticals (USA) Inc has received final approval from the US health regulator to market Clozapine tablets, used in the treatment of severe schizophrenia.
The company has got final approval from the US Food and Drug Administration (USFDA) to market the drug in the strengths of 25 mg, 50 mg, 100 mg and 200 mg, Zydus Cadila said in a BSE filing. The drug will be produced at the group’s formulations manufacturing facility at SEZ, Ahmedabad. The Zydus group has more than 175 approvals and so far filed over 310 abbreviated new drug applications (ANDAs) since it started filings in 2003-04.
Zydus Pharmaceuticals Inc is a wholly-owned subsidiary of Cadila Healthcare Ltd. Shares of Cadila Healthcare, the listed entity of the group, were up 0.41 per cent at Rs 418.80 per scrip on BSE today.