Shares of Piramal Pharma soared nearly 10% in early trade on April 19 after the US Food and Drug Administration (USFDA) concluded an inspection of the company’s Sellersville, US manufacturing plant.

Shares of Piramal Pharma were trading at Rs 77.50 on the National Stock Exchange at 10:18 am, up 7.86% from the previous close. The stock also tested an intraday high of Rs 78.75.

So far, 10 million company shares have changed hands on exchanges, compared with a one-month daily average of 3.8 million shares.

The facility is under inspection from December 19, 2022, until January 13, 2023. The FDA also issued an Establishment Inspection Report (EIR) following an inspection of the Sellersville manufacturing facility. The EIR is the final inspection report for FDA inspections.

Typically, the EIR includes detailed information on the classification of the facility being inspected, although this may not always be the case. It is important to note that receiving an EIR does not necessarily mean the facility has been cleaned.

Piramal Pharma’s Sellersville facility manufactures and packages various pharmaceuticals, including solid oral dosage forms, liquids, creams and ointments. This is a fully integrated site.

Domestic pharmaceutical companies have been grappling with heightened regulatory scrutiny from the USFDA, especially after the resumption of physical inspections post-COVID. Delays in obtaining FDA approval could delay a drug’s launch in the US market, hampering its commercial potential. Given that domestic pharmaceutical companies derive a significant portion of their revenue from US sales, delays in drug launches could hurt their financial performance.

The FDA also previously issued an EIR for Piramal Pharma’s Lexington unit in February.