The United States Food and Drug Administration (US FDA) has imposed an import alert, effectively a ban, on generic drug-maker Sun Pharmaceutical Industries’ plant in Gujarat. The plant at Karkhadi in Gujarat makes both drug ingredients and formulations.
An ‘import alert’ results in the detention without physical examination of drugs from firms that have not met so-called good manufacturing practices.
Recently, the company’s subsidiary Caraco received US FDA approval for Risperidone oral tablets. The oral tablet is used for the treatment of schizophrenia (a mental disorder).
Sun Pharmaceutical Industries is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India, US and several other markets across the world.
