Lupin receives three USFDA observations for Aurangabad facility

The US Food and Drug Administration (USFDA) carried out the inspection at the plant from May 6 to May 15, Lupin said in a statement.

Mumbai: Drug maker Lupin Wednesday said it has received three observations from the US health regulator for its Aurangabad-based manufacturing facility.

The US Food and Drug Administration (USFDA) carried out the inspection at the plant from May 6 to May 15, the company said in a statement.

"The inspection at the Aurangabad facility closed with three observations. The company is confident of addressing them satisfactorily," it added.

Prior to this, the company had received four observations from the US health regulators after the closure of pharmacovigilance inspection. Medical Dialogues had earlier reported that Lupin had received four observations in the establishment inspection report (EIR) given by the US health regulator following the closure of pharmacovigilance inspection.

Based in Mumbai, the company's key focus areas include paediatrics, cardiovascular, anti-infectives, diabetology, asthma and anti-tuberculosis.

Also Read: Lupin gets 4 USFDA observations after the closure of pharmacovigilance inspection