ANMDMR blocks Colebil and Panczebil in pharmacies due to active substance concerns

The National Agency for Medicines and Medical Devices of Romania (ANMDMR) announced on Thursday, 6 August 2026, the temporary suspension of certain batches of Colebil coated tablets (MA no. 13377/2020/01) and Panczebil gastro-resistant coated tablets (MA no. 5223/2012/01-02). Both products are manufactured by Biofarm SA and marketed in Romania.

According to a statement from the agency, the affected batches — whether held at the manufacturer's warehouse, within the distribution chain, or already in pharmacies — may no longer be sold until the verification process is complete. ANMDMR stated that the evaluation of data obtained from the checks will be treated as a priority, in order to guarantee Romanian patients' access to medicines of assured quality and safety.

The agency emphasised that this measure is preventive in nature and was taken pending full clarification of certain matters relating to the manufacturer of the active substance — bovine bile — used as a raw material in the production of both medicines. According to ANMDMR, the checks are unrelated to Biofarm SA's manufacturing process and, at this stage, there is no indication of any quality or safety issues with the finished products.

In a statement, ANMDMR explained: "The situation under review concerns the clarification of the compliance status and authorisations held by the manufacturer of the active substance contained in these 2 biological medicinal products for human use. ANMDMR is working with the competent national authority in the country where the raw material manufacturer operates, in order to verify compliance with applicable good manufacturing practice requirements."

Manufacturer Biofarm SA stated that it is providing support to the competent authorities to resolve the situation as swiftly as possible.