Zydus Cadila has received approval from the US FDA to market Promethazine Tablets, 12.5 mg, 25 mg and 50 mg an anti-emetic drug, in the US market and plans to launch the drug this year. The current sales of Promethazine Tablets in the US market as per IMS is estimated at USD 116 mn.
The group had recently received approval to market Ribavirin Capsules in the US market through its US subsidiary Zydus Pharmaceuticals USA Inc. So far the group has received 9 ANDA approvals, stated a release.
The process of filing ANDAs began in 2003-04 with the group filing 12 ANDAs, the largest number filed by an Indian company in the very first year of filing. Till date, the group has filed 28 ANDAs and 34 DMFs.