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FDA Prohibits Sun Pharma Halol Plant from Exporting Drugs to US
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Key Takeaways
- The FDA classified Sun Pharma's Halol plant as "Official Action Indicated" due to multiple infractions found during an inspection.
- The plant is banned from importing products to the US, except for medications facing shortages.
The agency noted ongoing safety violations at the location.
FDA took action against the plant based on the results of a June inspection.
Stock.adobe.com
Troubles continue at Sun Pharmaceutical’s Halol plant in Gujarat, India.
FDA declared that the plant is not compliant with US manufacturing rules, according to a report from Reuters.1 The agency has classified the plant as “Official Action Indicated” based upon the findings of an inspection carried out in early June. During the inspection, at least eight infractions were noted.
Why did FDA take action against Sun's plant?
As a result of this ruling, the plant will not be allowed to import any product to the United States. However, medications manufactured at the plant that are considered to be facing shortages in the US will be exempted from this rule.
In a statement obtained by CNBC, a spokesperson for the drug maker said, “Sun Pharma remains committed to working with the FDA and maintaining CGMP standards at all of its facilities to provide high-quality medicines to patients globally.”
This is not the first time this facility has come under fire from regulators.
According to a report from ProPublica,2 the FDA took action against the plant two-and-a-half years ago, banning the factory from the US market (albeit with certain drugs exempted). The news outlet also obtained the latest safety report from June of this year and detailed the issues cited by FDA.
The issues include:
- Failing to investigate the source of bacteria found in test vials.
- Failing to fix damaged equipment responsible for contaminating medications
- Workers improperly handling vials and stoppers
- Improper disinfecting of manufacturing areas and equipment
- Workers not changing gloves after pushing trash down into an overflowing bin.
This news comes only a few months after Sun announced that Richard Ashcroft would step into the role of CEO of North America operations.3 The new executive started in the role on June 16 of this year and succeeded Abhay Gandi. In a press release issued at the time, Ashcroft said, “I am honored to join Sun Pharma as the North America CEO. This is an exciting opportunity to lead a dynamic team committed to advancing Sun's portfolio of generic and innovative medicines. As Sun Pharma continues its growth trajectory, the North America region is poised to bring new treatments to the market and drive significant growth for the business. I look forward to building on our strong foundation, supporting patients throughout their journey and delivering the highest quality generic and innovative medicines to the people we serve."
"Richard has an extensive and impressive history of driving advancements in healthcare and implementing innovative solutions to get medicines to people in need," said Mr. Aalok Shanghvi. "As CEO of the North America business, Richard will continue delivering on our mission of improving patient outcomes and enhancing the quality of life for people across the U.S. and Canada."
Sun also recently posted its fiscal results for Q1FY26,4 which showed growth across various sectors of the business. In a press release issued at the time, chairman and managing director Dilip Shanghvi said, “Sun had a strong performance during the quarter, where the overall growth reflects steady progress across all our markets. India continues to show strong momentum, contributing meaningfully to our performance. The U.S. launch of LEQSELVI represents an important step forward, offering a new treatment option for patients with severe alopecia areata. LEQSELVI augments our portfolio in dermatology and adds a growth engine to our Innovative Medicines business."
Sources
- US FDA deems Sun Pharma's Halol plant not compliant with its manufacturing rules. Reuters. September 9, 2025. https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-deems-sun-pharmas-halol-plant-not-compliant-with-its-manufacturing-rules-2025-09-09/
- FDA Inspectors Again Find Dangerous Breakdowns at an Indian Factory Supplying Medications to U.S. Consumers. ProPublica. July 16, 2025. Accessed September 9, 2025. https://www.propublica.org/article/fda-drug-inspection-sun-pharma
- Sun Pharma Announces Appointment of Richard Ascroft as CEO North America. Sun Pharma. June 25, 2025. Accessed September 9, 2025. https://www.prnewswire.com/news-releases/sun-pharma-announces-appointment-of-richard-ascroft-as-ceo-north-america-302491282.html
- Sun Pharma reports Q1FY26 results. Sun Pharma. https://sunpharma.com/wp-content/uploads/2025/07/Press-Release-Sun-Pharma-Q1FY26-Financial-Result.pdf
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