Sun Pharma shares fall 3% after Baska facility gets US FDA 'official action indicated' tag

Sun Pharma shares fall 3% after Baska facility gets US FDA 'official action indicated' tag

Shares of Sun Pharmaceutical Industries fell 3% to Rs 1,738 apiece on December 18, a one-month low, after the US Food and Drug Administration classified its facility in Baska, Gujarat, as 'official action indicated' after inspection.

Classification means regulatory or administrative actions are recommended.

As per the USFDA, OAI implies that the regulator may withhold approval of any pending product applications or supplements filed from such facility till the outstanding observations related to non-compliance of manufacturing norms laid down by it.

This followed an inspection conducted at the facility by the regulatory body between September 8 and September 19, the company said in an exchange filing.

At 1:50 pm, shares of the Mumbai-based drug major were the worst hit in the Nifty 50 index. Over 2 million shares of the company changed hands on the NSE so far in the day. The stock fell after rising for six straight sessions, in which it had gained over 4%. Nifty Pharma index was trading 0.3% lower.

"This is an important facility for co's injectable generic filings in US and new product approvals from this facility can be delayed substantially," said global brokerage Citi.

Sun Pharma said it continues to manufacture and supply approved products from Baska facility to US market and it will work to achieve fully compliant status.

Citi said classification poses risk of a negative impact on FY27 estimates for Sun Pharma's US generic sales and EPS.

So far in 2025, Sun Pharma shares fell 7% while Nifty Pharma index fell nearly 4%.