Hungary’s health regulator revokes GMP certificates of Panacea Biotec arm’s Baddi unit

The National Centre for Public Health and Pharmacy, Hungary (NCPHP) has revoked the good manufacturing practice (GMP) certificates it had issued to Panacea Biotec Pharma’s (PBPL) facility in Baddi, Himachal Pradesh.

PBPL is a subsidiary of Panacea Biotec. The action follows the inspection of the facility by NCPHP from January 26-31 and issues of a statement of non-compliance with GMP. NCPHP has considered that the Baddi facility does not comply with the GMP requirements as laid down in Directive (EU) 2017/1572 resulting in revocation of all valid GMP certificates, the parent company said in a filing on Thursday. Panacea Biotec shares closed 2.94% lower at ₹369.65 each on the BSE.

NCPHP has proposed halting of supplies of non-vital products, except those supplying patients being on treatment with oncology products. However, its officials did not observe any behaviour or manufacturing process that would pose risk to the quality of products already released.

PBPL is not supplying any oncology related products in European Union markets. During 2024-25, PBPL’s revenue to EU markets contributed around 0.32% of the total consolidated net revenues of Panacea Biotec. PBPL’s export revenue in

European Union markets represents products that are vital for patients undergoing long term immunosuppression or anti-viral therapy. Any interruption of supply could pose a significant clinical risk to patients. This aspect is being taken into account in the ongoing risk-benefit assessment in close coordination with the relevant regulatory agencies.

“We are in the process of implementing comprehensive corrective and preventive actions (CAPA) and will request a re-inspection at the earliest possible opportunity to restore the GMP certificates,” Panacea Biotec said.