The US Food and Drug Administration (FDA) has completed a pre-approval inspection of Lupin’s manufacturing facility in Somerset, New Jersey, USA, with one observation.

Lupin stated in an exchange filing that the inspection was carried out from September 29 to October 10, 2025.

The company confirmed that it will address the observation and submit its response to the FDA within the stipulated timeframe, reiterating its commitment to full compliance with Current Good Manufacturing Practice (CGMP) standards across all its facilities.

Lupin operates in 11 countries across six continents, supplying medicines to over 100 markets worldwide. In the United States, the company has a strong presence through its manufacturing, research and development, and commercial operations spanning generics, complex generics, biosimilars, and branded pharmaceuticals.

Established in 2003, Lupin Pharmaceuticals Inc., headquartered in Baltimore, Maryland, has expanded to five offices along the US East Coast, supported by a nationwide salesforce.

In 2015, the company established its Center of Excellence for Inhalation Research in Coral Springs, Florida, followed by the acquisition of Novel Laboratories to establish Lupin Somerset — its first US-based manufacturing facility. By 2017–18, Lupin achieved a significant milestone as its US revenues surpassed USD 1 billion.