pharmaceutical company Sun Pharma reports progress in addressing regulatory issues at three of its plants under investigation by the US Food and Drug Administration (USFDA)
In a recent development, Sun Pharmaceutical Industries, one of India's leading pharmaceutical companies, is facing US Food and Drug Administration (USFDA) compliance issues at its Halol facility in Gujarat, India. The FDA conducted a Good Manufacturing Practices (GMP) inspection from June 2 to June 13, 2025, resulting in a Form-483 with eight significant observations highlighting potential GMP violations at the plant.
The Halol plant remains under an FDA import alert, which has been in place since December 2022 due to earlier compliance problems. The recent FDA inspection reaffirmed concerns about the facility’s operational compliance, but detailed specifics of the 8 observations have not been publicly disclosed.
The issuance of Form-483 indicates serious issues but is not a final non-compliance determination; it requires Sun Pharma to respond with a corrective action plan within the regulatory timeline. Despite the import alert and observations, the FDA has reportedly allowed some continued shipments from the Halol facility through a special internal exemption to avoid drug shortages, a move criticized for potential risks to public safety.
Sun Pharma is expected to submit a detailed corrective and preventive action (CAPA) plan addressing each of the observations to the FDA promptly after receiving Form-483. The FDA will review the company’s response and may conduct a follow-up inspection to verify remediation. The timeline for resolving these issues typically depends on the nature and extent of violations but often ranges from several months to over a year. Until the FDA is satisfied with the corrective measures, the Halol plant is likely to remain under import restrictions, affecting its ability to export to the US market.
Meanwhile, Sun Pharmaceutical Industries continues to focus on its business growth. The company reported consolidated revenues of ₹52,041 crore in FY25 and aims to expand its product pipeline of global speciality products. Sun Pharma's share of global speciality business in its sales increased from 18 per cent in FY24 to 20 per cent in FY25. The company invests significantly in R&D, with $154 million spent on speciality products R&D in FY25.
Sun Pharma's global speciality business, led by products like Ilumya, Winlevi, Cequa, and Odomzo, is expected to continue on its growth path, according to Dilip Shanghvi, the company's chairman. Shanghvi also emphasized the company's continued focus on cost and operational efficiency. He anticipates mid to high single-digit consolidated topline growth in FY26.
Sun Pharma is also working on implementing CAPA at its Mohali and Dadra facilities, aiming to bolster compliance across its manufacturing operations. However, the article does not provide new facts related to the compliance issues or the status of CAPA implementation at the Sun Pharma facilities.
[1] https://www.mintpro.com/news/companies/sun-pharma-fda-inspection-at-gujarat-plant-ends-8-observations-reported-1631300576798.html [2] https://www.mintpro.com/news/companies/sun-pharma-receives-fda-non-compliance-letter-for-mohali-facility-1631128779954.html [3] https://www.livemint.com/companies/news/sun-pharma-s-halol-facility-under-fda-import-alert-for-compliance-issues-1631300576798.html [4] https://www.bloombergquint.com/onweb/sun-pharma-faces-fda-scrutiny-as-halol-plant-continues-to-face-import-alert#gs.c5b5613a
- Sun Pharmaceutical Industries, a significant player in the pharmaceutical industry, received Form-483 from the US Food and Drug Administration (FDA) following a Good Manufacturing Practices (GMP) inspection at its Halol facility in India, highlighting eight potential GMP violations.
- The FDA import alert, placed on the Halol plant since December 2022 due to earlier compliance issues, remains in effect and has led to some continued trade of stocks from the facility due to potential drug shortages, despite concerns about public safety.
- Sun Pharma is required to submit a detailed corrective and preventive action (CAPA) plan to address the FDA's observations and pass a follow-up inspection to resolve the compliance issues, which can take several months to over a year, potentially affecting its exports to the US market.
- Despite the compliance issues, Sun Pharma's overall business growth remains a focus, as the company reported consolidated revenues of ₹52,041 crore in FY25 and aims to expand its product pipeline, particularly its global speciality products.
- Sun Pharmaceutical Industries' global speciality business, represented by products like Ilumya, Winlevi, Cequa, and Odomzo, is anticipated to continue growing, while continuing to invest significantly in Research and Development (R&D) for $154 million in FY25.
- In response to the FDA inspections, Sun Pharma is also working on implementing CAPA at its Mohali and Dadra facilities to improve compliance across its manufacturing operations, but details on the status of CAPA implementation are not currently available.
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