Pharma major Lupin said that the inspection of the US Food and Drug Administration (USFDA) at its bioresearch facility in Pune has concluded without any observation.
Conclusion of an inspection without any observation indicates that the facility was found to be up to the standards expected by the FDA.
This is also the fifth time that the centre has successfully passed the inspection without receiving Form 483 from the FDA.
In Form 483, the FDA typically outlines conditions or practices at a drug-making unit that may cause the products made there to be in violation of the US agency’s standard production requirements.
Lupin Bioresearch Centre conducts the in-vivo and in-vitro bioequivalence studies for Lupin in Pune.
The inspection also included a review of studies done at the center’s new site at Lupin Research Park, Pune.
“Such a high level of compliance reiterates Lupin’s commitment to high-quality standards across its world class research centres”, said Nilesh Gupta, Managing Director, Lupin.
On Tuesday, Lupin said it got an Establishment Inspection Receipt (EIR) for its Pithampur facility, which was slapped with five observations in an inspection in October.
The receipt of an EIR is considered good news as it means that the company can now use the facility to manufacture items that are meant to be sold in the US.
Lupin is one of the world’s biggest makers of generic drugs, and sells both branded and generic formulations, biotechnology products and pharmaceutical ingredients globally.
It is the world’s biggest manufacturer of anti-TB medicines and focuses on cardiovascular, diabetology, asthma, paediatric, CNS, GI, anti-infective and NSAID segments of the pharma market.