Solara Active Pharma Gets EIR for Puducherry Ibuprofen Plant Post USFDA Inspection
New Delhi: Solara Active Pharma Sciences Limited has announced the successful closure of a United States Food and Drug Administration (USFDA) inspection at its Puducherry-based ibuprofen manufacturing facility, with the regulator issuing an Establishment Inspection Report (EIR) classifying the site as "Voluntary Action Indicated (VAI)" and marking the inspection as closed.
The unannounced USFDA inspection was conducted between February 2 and February 6, 2026. Following the inspection, the company received four observations in the Form FDA 483, which were described as procedural in nature.
Solara submitted its response to the observations within the stipulated timeline set by the USFDA. Based on the company’s response, the regulator issued the EIR on April 24, 2026, confirming closure of the inspection.
Commenting on the development, Managing Director and CEO Sandeep Rao stated that the outcome reflects the company’s strong commitment to regulatory excellence and adherence to global quality standards across its manufacturing facilities. He added that quality and compliance continue to remain key pillars of the company’s growth strategy.
The Puducherry facility, which manufactures ibuprofen and its derivatives, is equipped with advanced infrastructure to cater to both domestic and international markets. The site has been inspected by multiple global regulatory authorities, including the USFDA, EDQM, MHRA, and HPRA.
Solara emphasized that it remains focused on maintaining high levels of quality compliance across all its operations, supported by robust systems and continuous improvements.
Solara Active Pharma Sciences Limited is a global API manufacturer with six manufacturing facilities and a dedicated R&D centre, offering a diversified portfolio of high-value APIs and contract manufacturing services. Its facilities are approved by leading international regulatory agencies such as USFDA, EDQM, MFDS, WHO, HPRA, and PMDA.
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