06.08.2026
PRESS BRIEFING
Information related to the temporary, preventive blocking of some batches of COLEBIL dragees and PANZCEBIL gastro-resistant dragees sold on the Romanian market by manufacturer Biofarm SA, until some aspects regarding the manufacturer of the active substance are clarified
The National Agency for Medicines and Medical Devices of Romania – NAMMDR has ordered the temporary blocking of some batches of medicines COLEBIL, dragees, MA no. 13377/2020/01, and PANZCEBIL, gastro-resistant dragees, MA no. 5223/2012/01-02, manufactured by Biofarm SA and marketed in Romania.
The measure is preventive and was adopted until certain aspects regarding the manufacturer of the active substance – bovine bile – which is used as a raw material in the manufacture of the two medicinal products are clarified.
The checks do not target the manufacturing process carried out by Biofarm SA nor do they currently indicate the existence of quality/safety issues of the finished products. The situation analyzed refers to the clarification of the compliance status and authorisations held by the manufacturer of the active substance which is used in the manufacture of the two biological medicinal products for human use.
The NAMMDR collaborates with the competent national authority in the country where the manufacturer of the raw material operates, in order to verify compliance with the applicable requirements regarding the Good Manufacturing Practice. Manufacturer Biofarm SA has provided support to the competent authorities’ endeavors to clarify the situation without delay.
Until these checks are completed, the product batches in the manufacturer’s warehouse and in the supply chain, including at pharmacy level, cannot be marketed. The evaluation of the data related to the checks shall be carried out as a priority, in order to ensure access to medicinal products of unquestionable quality, which are safety for patients in Romania.