Lupin: USFDA conducts fifth successive inspection without observations

Lupin Limited has announced about the successful completion of the United States Food and Drug Administration (USFDA) inspection at its Lupin Bio-research Centre (LBC) without any observations.

This is the company’s fifth successive inspection without any observations under Form 483. This indicates the qualitative compliance maintained by the company at its bio-research facility. LBC conducts the in-vivo and in-vitro bio-equivalence studies for Lupin in Pune. The said inspection included a review of studies done at the centre’s new site at Lupin research park in Pune.

On Tuesday, the company had received Establishment Inspection Report (EIR) for its Pithampur (Unit-3) facility which is involved in the manufacture of Metered Dose Inhalers (MDIs), Dry Powder Inhalers (DPIs) and Topical Formulations for the regulated markets.

Also, it began its new financial year FY20, with the launch of Tadalafil Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg for which it had received USFDA approval much earlier.

On Wednesday, the stock of Lupin was up by 1.6 per cent to Rs. 789.65 per share from its previous close of Rs. 776.85.