Caraco Pharmaceutical Laboratories Ltd. has received approval from the US Food and Drug Administration (FDA) to manufacture and market meperidine hydrochloride, a generic form of Sanofi-Synthelabo's Demerol, informed Narendra N. Borkar, Chief Executive Officer.
Meperidine hydrochloride is used to treat moderate to severe pain and has a US market of about $18 million. Product shipments are expected to commence by October.
Borkar added that Caraco has five additional drugs pending FDA approval and the Company expects to receive the go-ahead to manufacture some of these by yearend.
In addition to meperidine hydrochloride, Caraco has received FDA approval for five generic drugs over the past three quarters. All five are being manufactured and marketed. These are: 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 last month reported 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.
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 Caraco stockholder.