Panacea Biotec Pharma Limited (PBPL), a wholly owned subsidiary of Panacea Biotec Limited, underwent an inspection by the National Centre for Public Health and Pharmacy, Hungary (NCPHP) at its Baddi, Himachal Pradesh manufacturing facility. The inspection took place from January 26, 2026, to January 31, 2026. Following the inspection, NCPHP issued a "Statement of non-compliance with Good Manufacturing Practice" (GMP) on February 03, 2026, received by PBPL on February 04, 2026. This statement indicated that the Baddi Facility does not comply with GMP requirements as per Directive (EU) 2017/1572, leading to the revocation of all valid GMP certificates issued by NCPHP. NCPHP has proposed halting supplies of non-vital products, with an exception for oncology products for patients undergoing treatment. However, NCPHP officials did not observe any manufacturing processes or behaviors that would pose a risk to the quality of products already released. PBPL clarified that it does not supply any oncology-related products to European Union markets. In FY 2024-25, PBPL's revenue contribution to European Union markets was approximately 0.32% of Panacea Biotec Limited's total consolidated net revenues. These exports consist of vital products for patients undergoing long-term immunosuppression or anti-viral therapy, and any supply interruption could pose significant clinical risks. This aspect is being addressed in coordination with regulatory agencies. Panacea Biotec Limited is committed to maintaining high quality and compliance standards. The company is implementing comprehensive corrective and preventive actions (CAPA) and plans to request a re-inspection at the earliest opportunity to reinstate the GMP Certificates.
