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US FDA flags 8 observations at Sun Pharma's Halol plant post audit

Synopsis:

The US FDA issued Form 483 with eight observations following a GMP inspection at Sun Pharmaceutical’s Halol unit, which concluded on June 13, 2025. The facility remains under import alert. Sun Pharmaceutical Industries share price closed at Rs.1,688.70.


The US Food and Drug Administration (FDA) has issued a Form 483 with eight observations to Sun Pharmaceutical Industries Ltd following a recent inspection at its Halol manufacturing plant in Gujarat. The Good Manufacturing Practices (GMP) inspection was carried out between June 2 and June 13, 2025.

This development adds to the regulatory pressure on one of Sun Pharma’s largest manufacturing units, which is already under an import alert. The Halol facility was previously inspected in May 2022 and had received a warning letter from the US FDA following compliance concerns.

Also read: ITC completes Rs.400 crore acquisition of Sresta Natural Bioproducts

SUN PHARMACEUTICAL IND L

Trade

1685.3-2.50 (-0.14 %)

Updated - 16 June 2025
1689.80day high
DAY HIGH
1655.70day low
DAY LOW
2249326
VOLUME (BSE)

Key Takeaways

  • US FDA conducted a GMP inspection at the Halol plant from June 2 to 13

  • Form 483 with eight observations was issued at the end of the audit

  • The Halol facility remains under an existing import alert

  • Last US FDA inspection occurred in May 2022

  • Surprise audit first reported by media on June 3, 2025

  • Sun Pharmaceutical Industries share price closed at Rs.1,688.70 on Friday

Also read: US FDA issues VAI classification with no observations for Syngene plant

The issuance of Form 483 implies that the FDA has identified conditions at the plant that may need corrective action. While not a final determination of non-compliance, such findings require prompt responses and remediation by the company to avoid escalation to further regulatory action.

Table: Key Details of Halol FDA Audit

Item

Details

Facility Inspected

Halol manufacturing unit, Gujarat

Inspection Dates

June 2 to June 13, 2025

FDA Observations

Eight (Form 483 issued)

Import Alert Status

Ongoing (since prior inspection)

Last Inspection Before 2025

May 2022

Sun Pharmaceutical Industries share price

Rs.1,688.70 (as of June 13, 2025)

Regulatory Background And Market Impact

The Halol unit plays a crucial role in Sun Pharma’s supply chain for regulated markets, particularly the United States. Given the existing import restrictions, further FDA scrutiny increases compliance risks and may delay product approvals or exports from this site.

Although the company has not provided specifics on the eight observations, the Form 483 typically outlines issues related to manufacturing controls, quality assurance, or documentation practices. The company is expected to respond with a corrective action plan within the required regulatory timeline.

Sun Pharmaceutical Industries share price may reflect cautious investor sentiment in the coming sessions as the market digests the implications of the latest regulatory development.

Also read: City Union Bank confident of FY26 margins despite RBI rate cuts

Source: CNBCTV18

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