Traphaco fined 160 million VND for pharmaceutical manufacturing violations

Traphaco Joint Stock Company has been fined 160 million VND by the Drug Administration of Vietnam for multiple violations in its drug manufacturing processes. The penalties stem from three specific administrative infractions.

First, the company produced several batches of Piracetam 400mg capsules with minor changes compared to the approved registration dossiers without obtaining necessary regulatory approval. Second, multiple batches of Piracetam 400mg, Methorphan cough medicine, Nostravin, and Loratadin 10mg were produced with major changes to their approved registration profiles without authorization.

Third, the company was found to have used Luzenac 00 talc powder—which is designated as a food additive—in the production of various medicines, failing to follow the approved manufacturing and testing procedures for raw materials. The Drug Administration applied the maximum fine within the applicable frameworks due to aggravating circumstances, including the large scale of the violations and the frequency of the infractions.