Revoking registration of drugs for treating erectile dysfunction, obesity, and pain relief

The Drug Administration of Vietnam (Ministry of Health) has just decided to revoke the registration for circulation in Vietnam of 3 drugs: Tadalafil, Odistad and Vacobufen, which are drugs to treat erectile dysfunction, obesity and pain and fever reduction.

Revoking the registration certificates of 3 drugs manufactured in Vietnam

3 drugs: Tadalafil 20 mg, Odistad 120 and Vacobufen 400 have had their circulation registration revoked, in document 283/QD-QLD signed by Deputy Director of the Department of Drug Administration Nguyen Thanh Lam on June 3, 2025.

The Drug Administration of Vietnam revoked the registration of 3 drugs in Vietnam, due to voluntary recall by the companies.

PHOTO: DAV.GOV.VN

In which, the drug Tadalafil 20 mg (Tadalafil 20mg), with registration number 893110457024 (old registration number VD-31364-18), is registered and manufactured by Meyer-BPC Joint Venture Company (address at Phu Tan Ward, Ben Tre City, Ben Tre Province).

Odistad 120 (Orlistat 120mg) medicine, with registration number 893100515124 (old registration number: VD-21535-14) registered by Stellapharm Joint Venture Company Limited (address in Hoc Mon District, Ho Chi Minh City); manufactured at Stellapharm Joint Venture Company Limited, Branch 1 (in Binh Duong province).

Vacobufen 400 medicine (Ibuprofen 400mg), registration number 893100032324 registered by Vacopharm Pharmaceutical Joint Stock Company (Ward 1, Tan An City, Long An Province); manufactured at Vacopharm Pharmaceutical Joint Stock Company (Ward Tan Khanh, Tan An City, Long An Province).

According to information from some treatment units and instructions for use, Vacobufen 400 is used for   pain relief, fever reduction for some diseases.

Tadalafil 20 mg treats erectile dysfunction in some cases. Odistad treats obesity in combination with diet, in adults. Both are prescription drugs, used only with a doctor's prescription after an accurate diagnosis.

According to the Drug Administration of Vietnam, the registration of the above 3 pharmaceuticals has been revoked because the registration facility requested to "voluntarily revoke the registration of the drug in Vietnam". Drugs manufactured before June 3, 2025 are allowed to be circulated until their expiry date.

Drug registration and drug manufacturing establishments must be responsible for monitoring and taking responsibility for the quality, safety and effectiveness of pharmaceuticals during circulation.

Previously, also in June, the Drug Administration of Vietnam requested health departments to strengthen inspection and supervision of pharmaceutical and functional food production activities.

Require drug manufacturing facilities to strengthen compliance with the principles of “good manufacturing practices” (GMP). Special attention should be paid to strictly controlling the origin, quality and use of pharmaceutical ingredients.

Pharmaceutical ingredients must be quality tested and meet quality standards according to standards approved by the Ministry of Health in the drug registration dossier.

Source: https://thanhnien.vn/thu-hoi-dang-ky-luu-hanh-thuoc-dieu-tri-roi-loan-cuong-beo-phi-giam-dau-18525060405462172.htm