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Our Bureau

Mumbai, Nov. 4 The warning letter to Detroit-based Caraco Pharmaceutical Laboratories Ltd from the regulator US Food and Drug Administration (FDA) will not impact revenues or the launch of products from either Sun Pharma or its subsidiary Caraco.

While new products from Sun Pharma’s production sites in India and the US will also not be impacted, Caraco could see a delay in the launch of new products, Sun Pharma’s representative told Business Line. Sun Pharma holds 76 per cent equity in Caraco.

The two “at risk” launches that Sun Pharma has undertaken in the US, of heart-burn drug Protonix and cancer-related drug Ethyol, are made in facilities in India, the representative added. Sun Pharma’s reaction was in response to Caraco’s filing to the US SEC on Monday, that the latter had received a warning letter from the USFDA. The observations in the letter included “the inadequate and untimely investigation” regarding quality control of certain incidents at Caraco’s facility that were contrary to standard operating procedures, the filing said.

Further, Caraco had said in its filing that the regulator could withhold the approval of pending new drug applications. Caraco has 19 pending new drug applications. However, the Sun Pharma representative added, the revenue projections did not include pending products.

Caraco had clocked revenues of $122 million in the second quarter of the current financial year. Only 25 per cent of those revenues came from Caraco’s own products, the rest came from the distribution of Sun Pharma’s products. Caraco has further said it would respond to the US FDA’s letter within a fortnight.

Sun Pharma’s shares were down close to 5 per cent, at Rs 1,054, on the BSE on Tuesday.

More Stories on : Outlook | Pharmaceuticals | Regulatory Bodies & Rulings | Sun Pharmaceutical Industries Ltd

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