Lupin gets EIR from USFDA for Dabhasa facility

15 Jul 2024 , 03:03 PM

Lupin’s stock jumped in early trading on July 15 after the business got the United States Food and Drug Administration’s (USFDA) Establishment Inspection Report (EIR) for its Dabhasa, Gujarat manufacturing facility.

At around 2.44 PM, Lupin was trading 2.13% higher at Rs 1,836 per piece, against the previous close of Rs 1,797.75 on NSE. The counter touched an intraday high and low of Rs 1,839.05, and Rs 1,801.25, respectively.

The EIR was issued following the facility’s latest inspection, which took place from April 8 to April 12, 2024.

The inspection finished with no observations, and the facility was classified as “No Action Indicated” (NAI).

The plant is part of Lupin Manufacturing Solutions (LMS), a company that develops, manufactures, and sells active pharmaceutical ingredients, as well as conducts contract development and manufacturing.

Lupin’s recent success in the US (sales climbed ~34% YoY in FY24) is due to its improved regulatory track record and traction in the inhalation portfolio. Following the launch of gSpiriva, the share of inhalation products in US sales increased from 25% in FY22 (USD 185 million) to 40% in FY24 (USD 326 million).

Growth in India had been muted due to the cessation of in-licensed brands (contribution fell from 15% in FY23 to 11% in Q4FY24), according to the broking company.

 

For feedback and suggestions, write to us at [e-mail]