Caraco Pharmaceutical Laboratories, the Detroit-based generic subsidiary of Sun Pharmaceuticals Ltd., has been issued a letter of warning by the US Food and Drug Administration (FDA), and all its future marketing approvals for medicines have been withheld due to some quality-control issues.

This action of the US regulator comes in the wake of certain technical inadequacies identified by it during a May 2008 inspection. The FDA considered some of its observations to be repeat observations, and hence issued the warning letter.

Caraco said the FDA observations include, among other things, the inadequate and untimely investigation by the quality control unit of certain incidents at the facility contrary to the company’s standard operating procedures.

Caraco Pharmaceutical Laboratories, the Detroit-based generic subsidiary of Sun Pharmaceuticals Ltd., has been issued a letter of warning by the US Food and Drug Administration (FDA), and all its future marketing approvals for medicines have been withheld due to some quality-control issues.

This action of the US regulator comes in the wake of certain technical inadequacies identified by it during a May 2008 inspection. The FDA considered some of its observations to be repeat observations, and hence issued the warning letter.

GlaxoSmithKline P. L. C.'s drug Avandia is facing flak for causing more than one dozen cases of liver failure and death in patients taking the drug according to a consumer advocacy group Public Citizen.

Drug maker, Ranbaxy Laboratories registered worst ever performance for the quarter ended September 30, 2008. The company suffered a loss of Rs 394.5 crore for the reporting quarter.

It had made a profit of Rs 207 crore in the corresponding quarter last year. Ranbaxy is already acquired by Japanese major Daiichi Sankyo. It is facing tough time in the US and US food department had already banned entry of its 30 drugs.  

Maneesh Pharmaceuticals Ltd, one of the leading pharmaceutical company, has joined hand with Disney Consumer Products (DCP) to market its Smyle range of baby care products under the Disney Baby brand. 

Mumbai-headquartered firm has entered into an exclusive licensing pact with DCP to develop, manufacture and market entire Disney Baby care range of products for South Asia and India. 

Maneesh Pharmaceuticals will enter the niche market of baby care products under its marketing division of Svizera Health Remedies, primarily cater to personal care needs of infants. The firm will market Disney Baby care product range which includes Baby Massage Oil, Soap, Bath, Shampoo, Talc Powder, Lotion and Wet Wipes.