Traphaco also used raw materials and carried out manufacturing processes that did not comply with its approved dossiers, according to a sanction decision issued by the Drug Administration of Vietnam on 9/10. Traphaco, headquartered in Hanoi, was fined a total of VND 160 million for three categories of violations.

Specifically, the company produced multiple batches of Piracetam 400 mg hard capsules with minor changes compared to the approved drug registration dossiers, which had not yet been authorized by the competent authority. In addition, Traphaco manufactured multiple batches of Methorphan, Nostravin, and Loratadin 10 mg cough medicines with major changes compared to their approved registration dossiers.

According to data provided by the inspection team, as of 1/1/2023, the drug batches involved in the violations included: two batches of Piracetam 400 mg with minor changes; 66 batches of Piracetam 400 mg, 473 batches of Methorphan, 11 batches of Nostravin, and 50 batches of Loratadin 10 mg with major changes; along with 21 drugs violating raw material and manufacturing, testing processes.

The third category of violations involved using Luzenac 00 talc, a raw material declared by the manufacturer for both pharmaceutical and food use, to produce various types of drugs. The regulatory agency determined that the company failed to follow the approved manufacturing and testing procedures for drugs and drug raw materials as outlined in the registration dossiers.

Traphaco's capsule manufacturing plant. *Photo: Traphaco*

Traphaco was fined VND 40 million for producing drugs with unapproved minor changes; VND 60 million for producing drugs with unapproved major changes; and VND 60 million for using raw materials, and implementing manufacturing and testing processes that did not comply with approved dossiers. The total fine amounted to VND 160 million.

The fine amount for organizations is calculated at twice the corresponding fine for individuals, as stipulated by Government Decree 90/2026 on administrative penalties in the healthcare sector.

The Drug Administration of Vietnam requires the company to strictly adhere to regulations concerning registration dossiers, input raw materials, and drug manufacturing and testing processes. Any changes to drug formulas, raw materials, or processes must be controlled according to approved dossiers to ensure product quality and meet pharmaceutical management requirements.

Le Nga