Sanctioned 230 million dong of pharmaceutical company with many aggravating circumstances

This company has the address 31 Ngo Thoi Nhiem, Vo Thi Sau ward, district 3, HCMC. The first product in violation is Chloramphenicol 250mg hard capsules (registration number: VD-24891-16, batch number: 0218, production date: 17/5/2018, expiry date 17/5/2021). level 2 according to the provisions of law, specified in Article 57, Decree 117/2020 of the Government.

This medicine is used to treat serious infections such as typhoid, paratyphoid, intestinal infections and some other infections.

Also violating quality at level 2 is Captopril tablet product (Captopril 25mg), registration number: VD-20545-14, batch number: 0119, production date: 22/2/2019, expiry date: 22/ February 2022.

Captopril is an angiotensin I-converting enzyme inhibitor, used in the treatment of hypertension and heart failure.

Nearly a year ago, the Drug Administration of Vietnam issued an official dispatch to suspend the circulation of Captopril 25mg with the above registration number, batch number and production date because it did not meet quality standards. This is considered an aggravating circumstance proposed by this Department, specified in Article 10 of the Law on Handling of Administrative Violations in 2012.

The third drug to be sanctioned is Batimin 125 oral suspension (registration number: VD-25824-16, batch number 0417, production date: November 8, 2017, expiry date: November 8, 2020) due to violations. quality level 2.

Batimin 125 oral suspension is effective in treating upper and lower respiratory infections; inflammation, vasculitis or lymph node inflammation, pyelonephritis, cystitis, uterine adnexitis, metritis…

According to the Drug Administration of Vietnam, the aggravating circumstance is that the company has twice produced this quality-infringing drug.

With 3 products violating level 2 quality, many aggravating circumstances, the Drug Administration of Vietnam fined this company 230 million VND. The Department also requires the company to destroy all of the above-mentioned infringing drugs.

Thanh Hien