Detroit-based Caraco Pharmaceutical Laboratories Ltd. (NYSE Amex: CPD) announced last week that G. P. Singh Sachdeva will assume the position of CEO following the resignation of Jitendra N. Doshi as interim CEO and director as of Nov. 1 due to personal and health reasons.

In a statement, Caraco thanked Doshi “for his many contributions during his years of service to the company, including his recent efforts in achieving significant progress with respect to our remediation activities.”

The company said Doshi would continue to assist in the trandition to Singh’s leadership.

Singh, 42, has served as the company’s COO since July. He also served as senior vice president of business strategies of the company from July 2007 to July 2010, as well as vice president of sales and marketing from September 2003 to July 2007, and national sales and marketing manager from September 2000 to September 2003. Singh has played a prominent and significant role in the Company’s success since joining  Caraco in 2000.

After the company’s annual meeting of shareholders, held on Sept. 13, Caraco received several questions from shareholders present which indicated a lack of clarity regarding the status of our remediation activities and the company’s expected rate of progress under the Consent Decree of Condemnation, Forfeiture and Permanent Injunction (the “Consent Decree”) entered into with the FDA Sept. 29, 2009. As a result, Caraco provided the following update on its remediation status.

Under the terms of the Consent Decree, before resuming the manufacture of any product in the company’s manufacturing plant in Detroit, a number of significant steps and processes are required to be completed, and certifications and approvals from both outside experts and the FDA are to be obtained. The company has made significant progress toward completion of this endeavor for its first set of two products, and currently believes, as previously disclosed, that it will commence manufacture of these first two products by the end of fiscal 2011.

A second set of two or three products is planned for manufacture during the third quarter of fiscal 2012. Accordingly, by the end of fiscal 2012, the company expects to be manufacturing and distributing four or five products with a total minimal annualized sales volume. The company will be required to augment this minimal volume of sales by the sale of Caraco owned products manufactured at third party sites and sales of distributed products.

All of the company’s prior approved products, together with the new products pending approval from the FDA, will be subject to these same processes, certification and approvals as set forth in the Consent Decree. The company believes that, even assuming a smooth remediation process, it will take significant time before the company reaches its previous levels of manufacturing in its Detroit plant.

Caraco develops, manufactures, markets and distributes generic and private-label pharmaceuticals to the nation’s largest wholesalers, distributors, drugstore chains and managed care providers.

(c) 2010, WWJ Newsradio 950. All rights reserved.


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