Solara Active Pharma Sciences Ltd announced the successful closure of its US FDA inspection at its Mangalore manufacturing unit. The facility received an Establishment Inspection Report (EIR) with Voluntary Action Indicated (VAI) classification, underscoring strong compliance and commitment to global quality standards.
Solara Active Pharma Sciences Limited , a leading manufacturer of active pharmaceutical ingredients (APIs), has successfully completed a recent inspection by the United States Food and Drug Administration (US FDA) at its Mangalore multi-product facility. The inspection, conducted between August 25-29, 2025, resulted in an Establishment Inspection Report (EIR) classified as Voluntary Action Indicated (VAI).
The VAI classification means that while minor procedural observations were noted, no significant violations were found, and the company demonstrated strong adherence to Good Manufacturing Practices (GMP). This is part of Solara’s ongoing focus on maintaining world-class quality and regulatory compliance across its manufacturing sites.
The Mangalore facility, established in 1997, is a critical site capable of producing high-value APIs and intermediates, contributing significantly to Solara’s global supply chain. The successful clearance further strengthens Solara's position as a trusted pharmaceutical supplier worldwide.
Key Highlights
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US FDA inspection at Mangalore facility completed successfully from August 25-29, 2025.
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Facility received an EIR with VAI classification indicating minor procedural matters only.
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Mangalore plant is a multi-product unit producing niche high-value APIs and intermediates.
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Reinforces Solara’s global commitment to quality and compliance with regulatory standards.
This audit follows Solara’s consistent track record of achieving zero 483 observations in recent US FDA audits.
Sources: Solara official releases, Medical Dialogues Bureau, MoneyWorks4Me, MarketScreener.