Production licenses of 47 drugs without dedicated manufacturing facilities revoked

The Department of Drug Administration has revoked the production, sale-distribution and import licenses of 47 types of immunosuppressant drugs that lacked dedicated manufacturing facilities.

According to the department, the decision was made at the director-general level on Asoj 20, cancelling the production licenses, sale-distribution and import registration certificates, and import recommendation letters for these drugs. The department said the step was taken after the deadline set in an earlier notice on risk assessment expired.

The department said the decision was made to ensure the quality and safety of medicines and to reduce the risk of cross-contamination from one drug to another. The revoked drugs include tofacitinib, leflunomide, mycophenolate mofetil and tacrolimus, with brands linked to both domestic and foreign manufacturers.

The list includes brands such as Lefron, Emulef, Leflu, Rulef, Liftyab and Takfa, among others.