Aurobindo Pharma Limited, a Hyderabad-based manufacturer of generic pharmaceuticals and active pharmaceutical ingredients (APIs), has received approval from the US Food and Drug Administration (USFDA) to manufacture and market modafinil tablets in 100mg and 200 mg strengths.
The product, which has been approved out of Aurobindo’s Unit-VII formulations facility in Hyderabad, is ready for launch, the company said in a filing to the BSE on Friday.
Modafinil tablets, the generic equivalent of Cephalon Inc’s Provigil tablets, are indicated for treatment of narcolepsy, shift work sleep disorders and excessive daytime sleepiness associated with obstructive sleep apnea.
According to IMS Health, the product has a market size of approximately $1.2 billion for the 12 months ending March 2012, the company added.
Aurobindo now has 160 ANDA (abbreviated new drug application) approvals from the USFDA. Of these, 25 are tentative approvals and 135 final approvals, including one for Aurolife Pharma LLC, a wholly-owned subsidiary of Aurobindo Pharma USA Inc.
Aurobindo’s scrip is currently trading at Rs 139.85 on the BSE, down 0.67%, over the previous close of Rs 140.80.
