Mumbai, Oct. 1: Sun Pharmaceuticals Industries Ltd today announced that its arm, Caraco Pharmaceutical Laboratories Ltd, has received approval from the US Food and Drug Administration (FDA) to manufacture and market ticlopidine hydrochloride, a generic form of Hoffman LaRoche’s Ticlid.
According to Narendra Borkar, chief executive officer, ticlopidine hydrochloride is a platelet aggregation inhibitor for cardiac patients, with a US market of about $ 32 million. Product shipments of the drug are expected in November. Caraco has received FDA approval for six generic drugs over the past four quarters. All the six drugs are being manufactured and marketed.
Borkar pointed out that Caraco has four additional drugs pending FDA approval and the company expects to receive approval for one or two of these by the year-end. The company recorded a 378 per cent jump in first-half sales to a record $ 8.9 million, with a gross profit of $ 4.5 million.
Sun Pharma is the largest shareholder in the US-based firm with a 47 per cent stake.
Caraco has an extensive R&D centre in Detroit.