Ranbaxy Laboratories, which has agreed to be taken over by Japan’s Daiichi Sankyo, received a major jolt today with the US Food and Drug Administration warning it will block over 30 generic drugs following ongoing procedural violations in some of its plants in India.

The company shares slid nearly 10.5 per cent intra-day before closing 6.5 per cent lower than Tuesday's close at Rs 379.10 in the Bombay Stock Exchange.

In a warning letter, FDA said it was concerned that Ranbaxy’s aseptic operations were conducted under extensive steps, manual handling, and inadequate equipment usage at the manufacturing facilities of Dewas and Paonta Sahib. Decrying the FDA move, the company said in a statement, “Ranbaxy is very disappointed in the action FDA has taken today. The company has responded to each concern FDA has raised during the past two years and had thought that progress was being made.”

Citing poor common good manufacturing practices (CGMP), the US regulator has provided 30 days from the receipt of the letter to respond to the allegations. The FDA department of health and human services said, “While all shipments of articles manufactured at the Dewas site are subject to refusal of admission, under the circumstances FDA generally would not refuse shipments of Ganciclovir API.”

Ganciclovir, an active pharmaceutical ingredient (API) is used for the treatment of Aids. The US FDA has reasoned the allowing of import of Ganciclovir since Ranbaxy is the sole provider of this API and the country needs to maintain a sufficient supply. Ranbaxy said the FDA announcement, the warning letters and Import Alert do not apply to its other facilities including the three facilities in the US, from which some 59 drug products are delivered to the US healthcare system. The statement says, "We are, however, pleased that FDA's testing and review led the agency to conclude that there is no reason to question the safety or effectiveness of Ranbaxy's drugs. The company has just received the warning letters that FDA has issued and has not had the opportunity to review those concerns that FDA has determined are unresolved. Once it has had an opportunity to review the issues, the company looks forward to continuing to cooperate with FDA to resolve the remaining issues.”