FDA blocks entry of 30 Ranbaxy drugs into US...

Domestic pharma major Ranbaxy has suffered some shocks in recent times, but this may well be the most serious one. The US Food and Drug Administration on Tuesday issued an "import alert" on over 30 generic drugs produced by Ranbaxy at its Dewas and Paonta Sahib plants in India, in effect blocking their entry into the company's largest market, due to "serious manufacturing deficiencies". The FDA also issued two warning letters to the company pointing out its concerns about deviations from standard manufacturing processes and systems (Good Manufacturing Practice requirements certified by the agency) at the two facilities — Dewas (Madhya Pradesh) and Paonta Sahib (including the Batamandi unit) in Himachal Pradesh. However, the FDA clarified that there was no reason to consider the drugs hazardous for consumption, it only had issues with the quality of manufacturing processes at the Indian plants. Ranbaxy's half-yearly sales (January-June) in US stood at $230 million this year. Last year, the US contributed $390 million of the company's total revenue of $1.6 billion. Analysts expect that the company's sales may take a knock of $75-100 million this year. As the alleged violations are of a critical nature, they will take some time to resolve and the company may take a hit of around $200 million on sales next year. Analysts estimate that the 30 drugs amount to around 40-50% of Ranbaxy's total US sales. Under an import alert, officials may detain at the US border, any active pharmaceutical ingredient (primary therapeutic component of a finished drug) and drugs manufactured at these facilities and imported to the US, though there is no evidence to suggest that Ranbaxy shipped defective products, a FDA statement said. The drugs on the list include popular antibiotics, cholesterol medicines and others like Cefuroxime Axetil, Ciprofloxacin HCl, Clarithromycin, Lamivudine, Ofloxacin, Pravastatin Sodium, Ranitidine, Simvastatin and Valacyclovir HCl. Shares of Ranbaxy dropped after the news broke out. The scrip closed at Rs 379, down 7% on the BSE. Source: The Times of India