Ranbaxy Laboratories, a Rs.12,250 crore pharma giant, has received yet another setback regarding quality issues. Ranbaxy received the form 483 from US FDA with certain observations as a result of the recent inspection at its API plant at Toansa, Punjab, India. The company is assessing the observations, and will respond to the US FDA in accordance with the agency's procedure to resolve the concerns at the earliest. The Toansa API facility is providing nearly 75 per cent of the pharmaceutical ingredients.
The company further clarified that it will continue to improve its systems and processes, and remains fully committed to upholding the highest standards that patients, prescribers, regulators and all other stakeholders expect from the company. Ranbaxy stays firmly committed to its philosophy of quality and patients first.
Ranbaxy scrip declined by two per cent in the morning session today.
The company supply APIs and intermediaries to leading innovator and generic pharmaceutical companies in more than 63 countries covering a wide range of therapeutic segments like anti-obesity, cardiovascular, anti-infective, central nervous system, anti-viral and dermatology. It achieved sales of US$ 137 million in 2012.
Earlier, it recalled atorvastatin calcium tablets in the USA due to the potential presence of very small glass particles resembling a fine grain of sand. It had charged a one-time inventory write-off on its books. However, the production of atorvastatin drug substance resumed in February 2013 and the product has now been reinstated in the US market.