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, announced Narendra N. Borkar, Chief Executive Officer.
Ticlopidine hydrochloride is a platelet aggregation inhibitor for cardiac patients. Ticlopidine hydrochloride has a US market of about $32 million. Product shipments are expected in November.
Caraco has received FDA approval for six generic drugs over the past four quarters. All six are being manufactured and marketed. These are: meperidine hydrochloride, a generic form of Sanofi-Synthelabo''s Demerol; metformin hydrochloride, a generic form of Bristol Myers Squibb''s Glucophage; oxaprozin, a generic form of G.D. Searle''s Daypro; carbamazepine (chewable), a generic form of Novartis'' Tegretol; clonazepam, a generic form of Roche''s Klonopin; and flurbiprofen, a generic form of Pharmacia''s Ansaid.
Aided by the extended productline, the Company recorded a 378% jump in first-half sales to a record $8.9 million, with a gross profit of $4.5 million. Year-to-date sales are running ahead of the $16 million to $18 million guidance for 2002.
Borkar noted that Caraco has four additional drugs pending FDA approval and the Company expects to receive the approval for one or two of these by yearend.
Caraco has an extensive R&D Center at its Detroit headquarters complex and receives R&D support from Sun Pharmaceutical Industries Ltd., India''s fifth largest specialty pharmaceutical firm. Sun is a major stockholder of Caraco.