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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Caraco Pharmaceutical Laboratories, Ltd. Common Stock | AMEX:CPD | AMEX | Ordinary Share |
Price Change | % Change | Share Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.00 | - |
DOW JONES NEWSWIRES
Caraco Pharmaceutical Laboratories Ltd. (CPD) said third-party products not seized by the U.S. Food and Drug Administration in a Thursday raid will generate sufficient profit to cover the generic-drug maker's continuing operating expenses.
"We expect that our financial position will allow the company the time to resolve its pending FDA issues," Caraco said.
Investors welcomed the news, sending shares up 9.6% to $2.62 in Friday morning trading. Shares on Thursday closed down 43% following the raid.
The FDA said it seized more than 30 Caraco-made generic drugs after the agency found manufacturing defects at company plants, including oversized tablets.
Caraco develops generic drugs for the prescription and over-the-counter markets. Its products include a version of epilepsy treatment Tegretol. The company also produces a generic version of the diabetes drug Glucophage.
On Friday, the company, which said the estimated value of the inventory involved in the raid is $15 million to $20 million, also noted it has a cash position of about $64 million, including an $18 million loan.
Deborah Autor, director of the FDA's office of compliance in its drug division, said patients taking any generic drugs made by Caraco should continue taking them.
The company makes a wide variety of drugs, including the popular diabetes medicine metformin, and the pain reliever tramadol. Autor said patients may not realize the generic drug they are taking is made by Caraco, but added that any defective drugs have already been recalled or are seized.
The FDA seized the products after Caraco's "continued failure" to ensure the quality of its manufacturing processes, Autor said. The FDA said the seizure may create a shortage of one medicine, choline magnesium trisalicylate oral tablets, commonly used as pain relievers. In that instance, physicians should switch patients to a safe alternative.
RBC Capital Markets analyst Adam Greene said the drug seizure, which followed warning letters and recalls over the past several months, also shines a spotlight on the "long list" of generics that have suffered "significant deviations from current good manufacturing practices over the last 12 months."
"We hear frequently from generic buyers now that quality and reliability are becoming a much bigger part of the decision process today compared to price, which was the single most important factor two-three years ago," he said.
-By Mike Barris, Dow Jones Newswires; 201-938-5658; mike.barris@dowjones.com
(Jared A. Favole contributed to this article.)
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