Lupin
US FDA clearance in lupin pharma
Lupin's shares saw a substantial increase of about 4 percent, reaching a 52-week high at Rs 1,184.70 on September 29. This surge was prompted by the US Food and Drugs Administration (FDA) issuing an Establishment Inspection Report (EIR) for Lupin's Nagpur unit-I manufacturing facility.
It's worth noting that the EIR signifies the conclusion of the FDA's inspection, with Lupin's Nagpur unit being categorized as Voluntary Action Indicated (VAI). In simpler terms, the VAI classification suggests that although certain issues were identified during the inspection, they were not deemed serious enough to warrant official regulatory action.
Back in July of the same year, the USFDA had issued a Form-483 with two observations regarding Lupin's Nagpur oral solid dosage facility.
Lupin has faced ongoing challenges in obtaining regulatory clearance, so the VAI status has brought a sense of optimism to investors, as it represents a positive step forward.