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
Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751 To know about our editorial team click here
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