Caraco reaches agreement with FDA panel (AMEX: CPD)

By Becky Shadle on 10/02/2009 – 6:00 am PST -- Biotech

Caraco Pharmaceuticals, an US-based subsidiary of Sun Pharma has agreed to go through a series of actions as per the requirements of the Food and Drug Administration of the United States of America after which the FDA would lift their ban on certain manufacturing units of Caraco Pharmaceuticals. The voluntary agreement was reached between the two today and Caraco has agreed to take a series of measures to satisfy the Food and Drug Administration panel so that they can approve and permit to resume the manufacturing units in the Detroit area.

Currently, Caraco Pharmaceuticals is facing a ban on certain manufacturing pharmaceutical products that are distributed in the Detroit and Michigan area for violating theFDA norms on the cGMP. Hence, this agreement is one solution for Caraco Pharmaceuticals to re-establish their manufacturing units by satisfying the FDA panel that they are working as per the FDA norms. In June this year, the Food and Drug Administration officials had seized around 33 drugs manufactured at the Detroit and Michigan plants of Caraco Pharmaceuticals and had stopped all of their manufacturing activities which had a direct impact on the shares of Caraco Pharmaceuticals.

However, to come out of this situation and to re-establish all their manufacturing activities, Caraco has decided to play by the FDA rules and has reached an agreement. Caraco’s spokesperson said that the company is working hard to satisfy the requirements of the Food and Drug Administration and has always retained Good Manufacturing Practice Certificate experts that review and look after company’s operations and make sure that they come out with successful results. Caraco also hopes that this voluntary agreement will help them to retain the market value that they had earlier.

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