The Drug Administration of Vietnam, operating under the Ministry of Health, has issued an extensive series of administrative sanctions against multiple pharmaceutical enterprises, locking in fines ranging from 115 million VND to 310 million VND. The underlying statutory violations primarily focus on the unauthorized marketing of medicines and raw materials prior to securing formal approval for major/minor variations, failure to submit required notifications for minor adjustments, neglecting to update product labels and patient sheets, price-declaration inconsistencies, and executing commercial trades with unlicensed entities. Concurrently, the regulatory body has issued an immediate nationwide suspension and recall order targeting a specific batch of sunscreen products due to formulation discrepancies.
The explicit breakdown of financial penalties and technical violations recorded for each pharmaceutical manufacturer includes:
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Mediplantex Central Pharmaceutical Joint Stock Company: Formed the most heavily sanctioned entity within this regulatory cycle, absorbing a total administrative fine of 310 million VND due to systemic compliance failures across its pharmaceutical operations.
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Hai Duong Pharmaceutical Medical Material Joint Stock Company: Hit with a financial penalty totaling 185 million VND. The firm was documented marketing 10 specified pharmaceutical assets (including Hadulacton 25, Nacepil, and Famotidin 40mg/4ml) without prior approval for major or minor variations; failing to process notifications for minor variations across 06 distinct medicines; neglecting mandatory label and patient insert updates for 02 product lines; and illegally selling Dimedrol 10mg/1ml to a retail pharmacy business operating outside its authorized commercial scope.
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SaVi Pharmaceutical Joint Stock Company: Mandated to pay an administrative fine of 175 million VND. Regulatory inspectors identified unauthorized major/minor variations regarding Masapon, SaVi Lansoprazole 30, SaVi Rosuvastatin 5, Paracetamol 500 tablets, and multiple batches of Rosuvastatin calcium raw materials. Supplementary violations included failing to notify minor variations for SaViCipro and Amisulpride/Ascorbic acid inputs, alongside sourcing Ascorbic acid raw materials from an enterprise lacking a valid certificate of eligibility for pharmacy business.
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September 2nd Pharmaceutical Joint Stock Company (NADYPHAR): Slashed with an administrative fine of 142.5 million VND. The manufacturer deployed multiple batches of finished medicines and raw components (such as Potassium chloride, Domperidone, Vigasmin 50mg, Ibuprofen, Dolnaltic, and Vildagliptin) into the market without securing required clearances for major/minor variations. NADYPHAR further failed to notify minor changes for 03 raw material batches and neglected to file official price-adjustment updates despite alterations in product profiles. The penalty was structurally amplified under aggravating clauses due to the extensive number of non-compliant batches involved.
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An Thien Pharmaceutical Joint Stock Company: Absorbed a flat administrative penalty of 115 million VND covering localized regulatory violations in its drug distribution workflows.
The technical parameters, recall parameters, and enforcement timelines defining the non-compliant cosmetic product feature:
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Targeted Commerical Asset: A specific production batch of Antisun Sunscreen (Notification Receipt No. 0402/24/CBMP-LA; Batch No. 0124DH; Manufacturing Date: March 15, 2024), placed on the market by Tami Natural Home Cosmetics Pharmaceutical Manufacturing Company Limited.
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Catalyst for the Sanction: Laboratory verification established that the actual chemical formulation of the commercial batch deviated from the mandatory ingredients profile formally filed within its official cosmetic product notification dossier.
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Enforcement Directives and Deadlines: The Drug Administration has mandated an immediate nationwide market suspension, recall, and total destruction of the non-compliant batch. Tami Natural Home is legally required to distribute recall alerts throughout its distribution networks, reclaim all distributed units, and submit a comprehensive verification report to the federal registry before July 25, 2026. The Department of Health of Tay Ninh Province is tasked with directing on-site surveillance over the destruction phase, with a hard deadline to submit its final compliance audit to the central administration before July 30, 2026.