Lupin reacts positively to EIR from USFDA

The shares of Lupin took cues from notification after one of its facilities received two observations from USFDA and opened higher by nearly three per cent. On Thursday, before the market hours, the company submitted a press release to the stock exchanges.

The statement stated that the inspection, which was carried on between February 3 and 11, 2020, concluded with two observations. This was carried out at Pithampur Unit-1, Madhya Pradesh facility by United States Food & Drug Administration (USFDA). The company received an establishment inspection report (EIR) which is one of the significant stages of drug clearance.

EIR comprises of a detailed report from the regulatory investigator based on its visit to the specific facility. Meanwhile, the observations by FDA can be taken only when its core area and number is known.

The management added that the EIR received is with voluntary action indicated (VAI) status. This could also mean that the observations found may not see administrative or regulatory actions. Though, the press note did not comment on any specific observational detail.

At 9.25 am on Thursday, the shares were trading at Rs 868 a piece with 1.6 per cent gains on BSE. The benchmark index-BSE Sensex traded higher by 2.36 per cent at 33,492.