Piramal Pharma zooms 10% as US FDA concludes inspection at US facility

Shares of Piramal Pharma surged nearly 10 percent in early trade on April 19 after the US Food and Drug Administration (USFDA) concluded its inspection of the company’s Sellersville manufacturing facility in the United States.

At 10.18 am, shares of Piramal Pharma were trading at Rs 77.50 on the National Stock Exchange, up 7.86 percent from the previous close. The stock also tested an intraday high of Rs 78.75.

One crore shares of the company changed hands on the exchanges so far, as against the one-month daily traded average of 38 lakh shares.

Inspection of the facility took place between December 19, 2022, and January 13, 2023. The US FDA also issued an Establishment Inspection Report (EIR) post the inspection of the Sellersville manufacturing facility. EIR is the final inspection report of an FDA inspection.

Catch all the market action on our live blog

Generally, the EIR includes details about the classification of the inspected facility, although this may not always be the case. It is important to note that receiving an EIR does not necessarily indicate that the plant has been cleared.

Piramal Pharma’s Sellersville facility engages in the manufacturing and packaging process of various forms of medications, including solid oral dosage forms, liquids, creams, and ointments. It is a fully integrated site.

Domestic pharmaceutical companies have been struggling with the heightened regulatory scrutiny from the US FDA, particularly after physical inspections resumed in the post-COVID period. When there is a delay in receiving approval from the US FDA, it can result in postponed drug launches in the US market, thus impeding their commercial potential. Given that domestic pharma companies earn a significant portion of their revenue from sales in the US, a delay in drug launches can have an adverse impact on their financial performance.

Previously, the USFDA had also issued an EIR for Piramal Pharma’s Lexington unit, in February.