Ranbaxy recalls skin care capsules from US market

07 Jul 2011 Evaluate

Ranbaxy Laboratories, country's largest drugmaker is recalling all unexpired stock of Isotretinoin 20-mg capsules, used in the treatment of severe skin conditions, from the UK market following a directive from the European Commission that the marketing authorization should be suspended as a temporary measure.

This is due to a potential issue with bioequivalence in comparison with the originator product. The recall is temporary, with no safety or quality concerns involved. The company-led recalls are usually seen in cases with a known and limited distribution and it is seen as beneficial not to contact large numbers of unaffected individuals.

Recently, Ranbaxy Laboratories was planning to start supplying a low-cost version of anti-ulcer drug, sold under the brand Nexium by AstraZeneca Plc to the British drugmaker, towards the end of 2011 and expects to start shipping the product in the second half of this year. This could fetch $40-50 million in annual revenues for Ranbaxy.

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