Caraco gets FDA nod for a drug
By September 2001, the interest payout | 09 Jan 2002
Chennai: The Detroit-based Caraco Pharmaceutical Laboratories has received the Food and Drug Administration's (FDA) approval to manufacture and market Oxaprozin tablets, used for the treatment of rheumatoid diseases.
Oxaprozin is the generic form of GD Searle's 'Daypro.' The total US market for the drug is estimated to be around $168 million. With this, the total FDA-approved drugs for Caraco Pharma go up to five.
Caraco Pharma develops, manufactures and distributes
generic and private-label prescription drugs to the nation's largest wholesalers and distributors, drugstore chains and healthcare systems. Caraco Pharma recently received a letter of approvability from the FDA to produce metformin hydrochloride, which is the generic form of Bristol Myers Squibb's diabetes drug Glucophage.
The company also got FDA's approval to manufacture and market three additional generic drugs: 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.
Says Caraco Pharma CEO Narendra N Borkar: "We have five additional drugs pending FDA approval, and we expect to receive approvals for the majority of these by the yearend."
The Mumbai-based Sun Pharma owns 48 per cent in Caraco Pharma. As per the scheme of things, Sun Pharma lends its research and development expertise to Caraco Pharma. The Indian company has agreed to supply Caraco Pharma the technology for 25 generic drugs.
Sun Pharma officials say the US company has got the technology for 10 abbreviated new drug applications (ANDA) products and two desi products. For its part, Caraco Pharma has issued a common stock for eight ANDA and two desi products to Sun Pharma.
Sun Pharma, in addition to lending sizeable sums to the US company, also stands as a guarantor for Caraco Pharma's debts. For the nine months ended 30 September 2001, the interest payout for Caraco Pharma stood at $1.5 million on a turnover of $3.3 million.
With the problems relating to good manufacturing practices (cGMP) resolved to FDA's satisfaction, Caraco Pharma's success now largely depends on its future finances.