More concerns over Ranbaxys Indian manufacturing facilities and Toansa plant
In a recent development, the US health regulator, USFDA, has raised concerns over a factorys manufacturing facilities of Ranbaxy Laboratories. As stated by the FDA, the companys manufacturing facilities have failed to comply with the good manufacturing practices (GMP), which was noted during a regulators inspection.
Based on the observed GMP violations, the USFDA has stated that India based factories of Ranbaxy labs, are banned from exporting medicines into the US market. US market is the company’s largest market and the drug company has Indias largest sales. However, in recent inspections, the FDA has noted certain observations in Ranbaxys Toansa plant in Punjab.
Specific concerns have been raised over manufacturing practices at the companys Toansa plant. The company has received a Form 483, stating about the observations at this plant, which refers to non-compliance of GMP standards. The Toansa plant of Ranbaxy is an active pharmaceutical ingredient (API) plant. The company needs to address these issues; otherwise it can lead to banning of all of the factory exports to the US.
The company aims to resolve these issues and improve their systems to meet high standards of current good manufacturing practices.