Press Trust of India / New Delhi May 17, 2009, 11:18 IST
Faced with massive losses coupled with regulatory hurdles in the US market, Ranbaxy Laboratories has chalked out plans to revamp its US business.
"Our focus will be to resolve regulatory compliance issues and continue to strengthen cGMP (certificate for good manufacturing practice) across all locations," Ranbaxy CEO and Managing Director Malvinder Mohan Singh said in the company's annual report.
For the year, 2009, Ranbaxy has a clear strategy to harness its growth potential in the emerging markets, rebuild the US business through a series of actions on products and facilities, the company said.
For the quarter ended March 31, 2009, Ranbaxy reported a loss of $153 million, while it posted a 14 per cent decline in its US business at $68 million.
The company is taking various actions for minimising its losses. It is also working to increase the capacity of its US-based subsidiary Ohm Laboratories, the company said.
In September last year, US health regulator Food and Drug Administration had banned the import of 30 generic medicines manufactured at Ranbaxy's two plants — Paonta Sahib and Dewas — in India.
Ranbaxy had indicated that it is looking for acquiring FDA approved manufacturing facilities to shift its products from Paonta Sahib and Dewas.
In February this year, FDA has also invoked AIP against the company alleging falsifying test results and data in its application for future product pipeline.
Under AIP, the company's abbreviated new drug applications were suspended and Ranbaxy had to apply fresh.
The company has formed a team of experts to resolve the issue and the team is expected to initiate the discussion with FDA officials last month.
The internal team along with a set of experts is engaged with a high degree of focus and commitment towards implementing a comprehensive plan of corrective actions, the company said.
US sales account for around 40 per cent of the company's total global sales and the US business alone contributed around $400 million to its overall earnings.
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