MUMBAI - U.S. FDA issued a warning letter to Caraco Pharmaceuticals, a subsidiary of India's Sun Pharmaceuticals, after the drug regulator found quality control lapses at its Detroit facilities, Curaco announced Nov. 3. U.S. FDA said the QC lapses conflicted with the company's standard operating procedures.

"Until the company's responses to the observations have been clarified and explanations provided to the satisfaction of the FDA, the FDA may in the near term withhold approval of pending new drug applications listing the facility as the manufacturer," Caraco said.

The warning letter was issued as a follow up to an FDA inspection of the company's manufacturing facility in Detroit, Michigan in May 2008. The U.S. FDA issued a Form 483 following that inspection.

"Caraco had subsequently taken corrective measures and substantially completed them," the company noted, adding that FDA considered some of its observations to be repeat observations.

Caraco said it disputed some of the observations in the warning letter, one of which cited inadequate and untimely investigation by the quality unit of certain incidents at the facility.

"The FDA action was mainly due to some dispensing error with one of the product batches. It has nothing to do with the products that are [on] the market currently," a Sun Pharma spokesman told PharmAsia News.

Caraco said the company is committed to working cooperatively and expeditiously with FDA to resolve matters indicated in the warning letter.

For the second quarter, Sun Pharma's U.S. subsidiary Caraco recorded sales of $122 million, which represented a 195 percent jump over the same year-ago quarter, which registered sales of $41 million (Also see "India’s Sun Pharma Hunts For Bargains Amidst Financial Crisis" - Scrip, 29 October, 2008.).

Through Caraco, Sun Pharma has launched generic versions of Wyeth's brand Protonix and MedImmune's Ethyol "at risk" (Also see "India’s Sun Pharma To Pursue Taro Merger As Q4 Profits Surge On U.S. Protonix Sales" - Scrip, 2 June, 2008.).

Sun Pharma and Caraco together have 61 new products approved in the U.S. The two companies have 96 products pending, of which 19 have been filed from Caraco.

In a similar crackdown, U.S. FDA issued warning letters to Ranbaxy on Sept. 16, citing manufacturing deficiencies in two of its plants located in India. The drug regulator also imposed an import ban on 30 products from the company that resulted in heavy losses in its third-quarter earnings (Also see "U.S. FDA Action Drives Ranbaxy Into Red; Company May Buyout Manufacturing Sites To Recover Lost Ground" - Scrip, 31 October, 2008.).

- Vikas Dandekar (v.dandekar@elsevier.com)

After Ranbaxy, U.S. FDA Hauls Up Caraco Pharma for QC Issues; May Withhold Future Drug Approvals

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