Caraco launches diabetes generic

Published: 18-Apr-2002
Regulatory


Detroit-based Caraco Pharmaceutical Laboratories has begun manufacturing and marketing its newly approved drug metformin hydrochloride, a bio-equivalent of Bristol-Myers Squibb's Glucophage, used in the treatment of diabetes. The US market for metformin hydrochloride is estimated at US$1.8bn (€2bn). Earlier this year, the company began marketing oxaprozin, its first drug approved by the FDA in 2002, the bio-equivalent of G.D. Searle's Daypro.

In January, Caraco received an approvable letter from the FDA for tramadol hydrochloride, the bio-equivalent of R.W. Johnson's Ultram, which has an estimated total US market of $555m (€629m).

Other generics for which the company has also received approvals include clonazepam (the bio-equivalent of Roche's Klonopin); carbamazepine (chewable), (equivalent to Novartis' Tegretol (chewable)); and flurbiprofen (equivalent to Pharmacia's Ansaid). These three drugs are now in production.

Caraco develops, manufactures and distributes generic and private-label prescription drugs to wholesalers, distributors, retailers and healthcare systems. It receives r&d support from Sun Pharmaceutical Industries, a specialty pharmaceutical firm in India.

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