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US FDA Flags Lupin’s Pithampur Unit-2 as Official Action Indicated

Synopsis:


The US FDA inspection at Lupin’s Pithampur Unit-2 in July 2025 led to a Form-483 with four observations and an “Official Action Indicated” status. The company is engaging with the regulator to address the compliance concerns.


Source:
Lupin Press Release (NSE Exchange Fillings) | Published on Oct 06, 2025

Disclaimer: This content has been published for informational purposes only. Bajaj Broking is not affiliated with, nor does it endorse or assume any responsibility for, the source material. Readers are advised to consult the original publication for complete and accurate context.

Lupin News Today

As quoted in the press release of Lupin (NSE Exchange Filings), the company has reported that the Pithampur Unit-2 manufacturing site has been classified by the US Food and Drug Administration (FDA) to be under “Official Action Indicated” (OAI) status. The OAI classification came following an inspection conducted from July 8 to 17, 2025, which ended with a Form-483 that contained four observations.

The company advised it is working closely with the US FDA to meet compliance issues raised and is committed to Current Good Manufacturing Practice (cGMP) standards at all of its global facilities.

Also read: Tata Steel receives ₹2,410 cr demand from Jajpur mines office

LUPIN LIMITED

Trade

1934.6-39.00 (-1.97 %)

Updated - 06 October 2025
1972.90day high
DAY HIGH
1929.20day low
DAY LOW
265143
VOLUME (BSE)

Key Takeaways

  • FDA conducted inspection from 8 to 17 July 2025.

  • Four observations were noted under Form-483.

  • Facility classified as Official Action Indicated.

  • Company is addressing compliance issues with the regulator.

Also read: Panacea Biotec Bags ₹315 Cr UNICEF Order for Bivalent Polio Vaccine

Significance of the OAI Status

The “Official Action Indicated” classification is given when the US FDA finds major non-conformance with cGMP standards, and the agency believes the situation warrants some sort of further enforcement action. This classification notifies the facility that the regulator expects corrective actions to be taken before any products from the facility may continue to have an active approval for export to the US market.

An “Official Action Indicated” classification can result in additional scrutiny, delays in product approval, or limitations to the number of products from a facility that can be shipped. It also indicates that the facility will likely be subject to regulatory engagement and follow-up inspections until the Agency is satisfied the issues noted during inspections or filed observations have been resolved.

Impact on Lupin’s Manufacturing and Market Outlook

The Pithampur Unit-2 is one of Lupin's important manufacturing places, specifically for oral solid dosage forms that are supplied to regulated markets. Any extended regulatory action could impact the timeliness of production and the global supply chain.

However, the company has communicated again its commitment to implementing corrective and preventive actions in a timely manner. Corrective and preventive actions must be put in place in order to ensure that operations can continue, and Lupin will still operate in important markets.

Market Response and Ongoing Developments

The market has been highly attuned to news after the OAI classification. Regulatory findings of this nature have the capability to shift investor sentiment, particularly when it involves significant production facilities supplying large foreign markets.

In the latest trading session on BSE on 3 October 2025 at 15:30 PM IST, Lupin share price is ₹1,981.30 per share, a gain of 3.66 %. The trajectory of the company will more than likely depend on the pace and adequacy of the company's corrective actions and the outcome of any future follow-up inspections.

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