Panacea Biotec shares fall after Hungary flags quality issues at Baddi unit

The National Centre for Public Health and Pharmacy (NCPHP) of Hungary conducted an inspection of Panacea Biotec Pharma Limited’s (PBPL) manufacturing facility at Baddi, Himachal Pradesh, from January 26 to 31, 2026.Following the inspection, NCPHP issued a “Statement of non-compliance with Good Manufacturing Practice” (GMP) on February 3, 2026.

The statement said the Baddi facility does not meet GMP requirements under Directive (EU) 2017/1572, leading to the revocation of all valid GMP certificates.
NCPHP proposed halting supplies of non-vital products, excluding oncology products, although it noted that no risks were identified in products already released to the market.
PBPL clarified that it does not supply oncology products to European Union markets. Revenue from the EU during FY2024-25 accounted for about 0.32% of Panacea Biotec Limited’s total consolidated net revenue.The exports include vital medicines used by patients on long-term immunosuppression or antiviral therapy, where any supply disruption could pose significant clinical risks. The company said it is undertaking a risk-benefit assessment in coordination with relevant regulatory authorities.

PBPL, a subsidiary of Panacea Biotec Limited, is implementing comprehensive corrective and preventive actions (CAPA) and plans to seek a re-inspection at the earliest to restore its GMP certificates.

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Panacea Biotec Ltd shares closed at ₹368.00, down ₹12.90 or 3.39% on Thursday.