Unichem Goa Facility Gets 5 USFDA Observations
New Delhi: Unichem Laboratories Limited's formulation facility in Goa has received five observations from the US Food and Drug Administration (USFDA) following an inspection conducted from September 21 to September 26, 2026, the company said in a regulatory filing.
The USFDA inspection was carried out at the company's Goa formulation facility located at Pilerne, Bardez, Unichem Laboratories said.
According to the company, the inspection concluded with five observations related to procedural enhancements.
Unichem Laboratories said it will submit the necessary response to the USFDA within the stipulated 15-day period.
The latest inspection comes as the company's Goa facility remains one of its key formulation manufacturing sites. The Goa plant was built in 1997 and caters to the company's export markets. The facility is located at Pilerne, around 12 km from Panjim, and manufactures pharmaceutical formulations for international markets.
The Goa plant has been inspected by regulatory authorities including the USFDA and the UK's Medicines and Healthcare products Regulatory Agency (MHRA). The facility is listed as approved by several international regulatory authorities, including the US FDA, MHRA, Australia's TGA, Brazil's ANVISA and the European Medicines Agency (EMA).
Unichem Laboratories was founded in 1944 by Late Amrut Mody and is headquartered in Mumbai. According to the company's official website, it has six manufacturing locations in India and serves more than 50 markets. Its product portfolio covers therapeutic areas including gastroenterology, cardiology, diabetology, psychiatry, neurology, anti-bacterials, anti-infectives and pain management.
The company operates both formulation and active pharmaceutical ingredient (API) manufacturing facilities. Its formulation plants are located in Goa, Baddi and Ghaziabad, while its API facilities are located in Roh, Pithampur and Kolhapur. Unichem also has a Centre of Excellence for research and development in Goa, with a focus on generic formulations, APIs and other pharmaceutical development activities.
