Jagsonpal Pharmaceuticals Limited has been issued a customs order confirming a differential duty of ₹51 million plus a penalty. This development follows recent regulatory challenges faced by the company, including a warning letter from the U.S. FDA regarding significant manufacturing lapses at its Rajasthan-based facility.
Key Highlights:
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Customs Order: The customs authority has passed an order against Jagsonpal Pharmaceuticals, confirming a differential duty of ₹51 million along with a penalty. This decision is related to incorrect classification of imported goods, leading to the levy of additional duties.
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Regulatory Issues: Jagsonpal Pharmaceuticals recently received a warning letter from the U.S. FDA due to deviations from Current Good Manufacturing Practices (CGMP) at its API manufacturing facility in Rajasthan. The company was cited for inadequate oversight of contract manufacturing operations and refusal to allow full access during an FDA inspection.
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Import Alert: The FDA placed Jagsonpal's products on Import Alert 66-40, effectively blocking them from entering the U.S. market until compliance issues are resolved.
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Financial Impact: These regulatory challenges may impact Jagsonpal Pharmaceuticals' financial performance and export business, particularly in the U.S. market.
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Future Plans: The company must address these regulatory issues by implementing corrective actions to ensure compliance with both Indian customs regulations and international CGMP standards.
This situation highlights the importance of regulatory compliance for pharmaceutical companies operating globally, as non-compliance can lead to significant financial and reputational consequences.
Sources: Jagsonpal Pharmaceuticals, U.S. FDA, Customs Authority