Aurobindo Pharma Share Price Slips After USFDA Flags 8 Observations – Stock Market Today

Market Performance

Aurobindo Pharma share price came under pressure in early trade on September 8, 2025. The stock opened weak after the company disclosed that the US Food and Drug Administration  had raised multiple procedural observations during a recent inspection.

At 09:25 AM, the stock was quoting at ₹1,036.60, down ₹7.80 or 0.75% on the BSE. The weakness came amid fresh regulatory scrutiny, making investors cautious.

Key trading levels highlight the volatility:

• 52-week high: ₹1,592.55 (September 13, 2024)
• 52-week low: ₹994.35 (April 7, 2025)
• Current price is 34.91% below its peak and just 4.25% above its low.
• Market capitalisation: ₹60,205.90 crore.

The data reflects how regulatory events continue to weigh heavily on pharma stocks, even when the issues flagged are procedural.

Main News – USFDA Inspection and Observations

The trigger for the decline was linked to the outcome of a recent USFDA inspection.

• The US regulator inspected Unit-XII, covering oral solids and injectable manufacturing operations located at Bachupally, Medchal Malkajgiri District, Telangana, between August 25 and September 05, 2025.
• Following the inspection, the USFDA issued a Form 483 listing 8 procedural observations. These apply to both oral solids and injectable facilities.

Importantly, the company clarified that all observations are procedural in nature, and it will provide a detailed response to the regulator within the prescribed timelines.

Company Details – Earlier Inspection at Subsidiary Facility

This is not the first time Aurobindo Pharma has come under USFDA scrutiny this year.

• On August 29, 2025, the USFDA issued a separate Form 483 with five observations during its inspection of Unit-I, the API manufacturing unit of Apitoria Pharma, a wholly owned subsidiary.
• That inspection was conducted between August 21–29, 2025, at Sangareddy, Telangana.
• Here too, the regulator flagged procedural observations only, with no mention of data integrity concerns.

This indicates that while compliance gaps exist, the concerns are operational rather than structural.

Summary

The recent dip in Aurobindo Pharma share price reflects the heightened sensitivity of markets to USFDA observations. While both inspections – at Unit-XII and Apitoria Pharma’s Unit-I – resulted in procedural findings, investors remain cautious given the company’s exposure to the US generics market.

Key takeaways:

• Stock slipped 0.75% in early trade post USFDA update.
• 8 observations raised at Unit-XII (oral solids & injectables).
• 5 observations earlier flagged at subsidiary facility, Apitoria Pharma.
• Observations are procedural, no data integrity issues.
• Stock trades closer to its 52-week low, far below its high.

The spotlight now shifts to how quickly Aurobindo Pharma can respond to the USFDA’s observations and strengthen compliance in upcoming inspections.