Panacea Biotec Discloses GMP Certificate Revocation Following NCPHP Inspection at Baddi
Panacea Biotec Limited disclosed regulatory challenges following NCPHP's inspection of its Baddi facility from January 26-31, 2026, resulting in GMP certificate revocation due to non-compliance with EU Directive 2017/1572. The company faces restricted supplies of non-vital products except for ongoing oncology treatments, though it clarified no oncology products are supplied to EU markets. With EU revenue representing only 0.32% of total consolidated revenues, the financial impact appears limited, while the company implements corrective measures and plans re-inspection to restore certifications.
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Panacea Biotec Limited has disclosed significant regulatory developments following an inspection by the National Centre for Public Health and Pharmacy, Hungary (NCPHP) at its subsidiary's Baddi manufacturing facility. The company made this disclosure under Regulation 30 of SEBI listing requirements on February 05, 2026.
NCPHP Inspection and Timeline
The NCPHP conducted an inspection of Panacea Biotec Pharma Limited's (PBPL) Baddi facility in Himachal Pradesh from January 26, 2026 to January 31, 2026. Following the inspection, NCPHP issued a "Statement of non-compliance with Good Manufacturing Practice" dated February 03, 2026, which was received by PBPL on February 04, 2026.
| Inspection Details: | Information |
|---|---|
| Inspection Period: | January 26-31, 2026 |
| Non-compliance Notice Date: | February 03, 2026 |
| Notice Received: | February 04, 2026 |
| Disclosure Date: | February 05, 2026 |
GMP Certificate Revocation and Product Supply Impact
NCPHP determined that the Baddi facility does not comply with GMP requirements as outlined in Directive (EU) 2017/1572, resulting in the revocation of all valid GMP certificates issued by NCPHP. The regulatory authority has proposed halting supplies of non-vital products, with an exception for patients currently on treatment with oncology products.
Importantly, the company clarified that PBPL is not supplying any oncology-related products in European Union markets. NCPHP officials did not observe any behavior or manufacturing processes that would pose risks to the quality of products already released.
Limited Financial Exposure to EU Markets
The regulatory action's financial impact appears contained given Panacea Biotec's limited European exposure. During FY 2024-25, PBPL's revenue from European Union markets contributed around 0.32% of the total consolidated net revenues of Panacea Biotec Limited.
| Financial Impact: | Details |
|---|---|
| EU Revenue Contribution: | 0.32% of Total Consolidated Revenue |
| Product Category: | Vital for immunosuppression/anti-viral therapy |
| Patient Risk: | Supply interruption poses clinical risk |
Corrective Measures and Re-inspection Plans
Panacea Biotec has committed to maintaining the highest standards of quality and compliance. The company is implementing comprehensive corrective and preventive actions (CAPA) and plans to request a re-inspection at the earliest opportunity to restore the GMP certificates. The company is conducting ongoing risk-benefit assessments in coordination with relevant regulatory agencies, particularly considering that their EU export products are vital for patients undergoing long-term immunosuppression or anti-viral therapy.
Historical Stock Returns for Panacea Biotec
| 1 Day | 5 Days | 1 Month | 6 Months | 1 Year | 5 Years |
|---|---|---|---|---|---|
| +3.13% | -0.74% | -9.34% | +9.21% | -18.11% | +34.04% |
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