The Drug Administration of Vietnam, operating under the Ministry of Health, has issued a series of administrative sanctions against multiple pharmaceutical enterprises across the country, locking in fines ranging from 115 million VND to 310 million VND. The identified violations primarily involve marketing medicines and raw materials prior to securing formal approval for mandated updates, failure to submit required notifications, neglecting to update product labels/patient sheets, price-declaration deficiencies, and executing commercial transactions with unauthorized entities. Concurrently, the regulatory body ordered an immediate nationwide suspension and recall targeting two cosmetic product lines due to formulation discrepancies.
The explicit breakdown of administrative penalties and technical violations recorded for each pharmaceutical manufacturer includes:
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Mediplantex Central Pharmaceutical Joint Stock Company: Absorbed the highest financial penalty within this enforcement cycle, hitting a total administrative fine of 310 million VND due to multiple compliance failures across its operations.
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Hai Duong Pharmaceutical Medical Material Joint Stock Company: Penalized with a total fine of 185 million VND. The manufacturer was documented marketing 10 specific pharmaceutical lines (including Hadulacton 25, Nacepil, Levofloxaxime, Famotidin, Skyld, Vitamin B12, Adrelido, and Bromxim) without completing required registration updates for changes that mandate prior approval; failed to notify the regulatory body where reporting was compulsory; neglected to update product labels and patient instruction inserts as directed by the Ministry of Health; and illegally distributed medicines to an enterprise operating outside its licensed business scope.
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SaVi Pharmaceutical Joint Stock Company: Ordered to pay an administrative fine of 175 million VND. Regulatory tracking recorded failures to register marketing authorization updates for multiple products, including Masapon, SaVi Lansoprazole 30, SaVi Rosuvastatin 5, Paracetamol 500, and Rosuvastatin calcium raw materials. Supplementary infractions featured a failure to execute minor variation notifications for specific drugs and raw inputs, alongside sourcing Ascorbic acid from a supplier lacking a valid certificate of eligibility for pharmacy business.
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September 2nd Pharmaceutical Joint Stock Company (Nadyphar, Ho Chi Minh City): Slashed with an administrative fine of 142.5 million VND. The company failed to execute regulatory procedures to amend or supplement its official marketing authorizations prior to launching several products into the market, including Potassium chloride, Domperidone, Vigasmin 50 mg, Ibuprofen, Dolnaltic, and select active ingredients. NADYPHAR further neglected to process mandatory notifications for minor variations on certain raw materials and failed to update relevant price-declaration records following operational updates. The case carried aggravating circumstances due to the extensive number of non-compliant batches involved.
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An Thien Pharmaceutical Joint Stock Company (Ho Chi Minh City): Absorbed a flat administrative penalty of 115 million VND covering localized regulatory violations in its drug operations.
The technical parameters, recall directives, and enforcement timelines defining the non-compliant cosmetic products feature:
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Targeted Commercial Assets:
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A specific production batch of Antisun Sunscreen (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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A specific batch of Whitening Sheet Mask Greentea face masks, placed on the market by TVR Joint Stock Company.
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Catalysts for the Recalls: Laboratory verification established that the actual chemical formulations of both retail assets deviated from the mandatory parameters formally filed within their approved product notification dossiers.
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Enforcement Mandates and Deadlines: The Drug Administration has ordered an immediate nationwide market suspension and recall of the non-compliant batches. Consumers and direct-selling establishments are urged to halt all usage or sales of these products immediately and return them to their respective suppliers. The two participating companies are legally required to complete the total retrieval and destruction of the non-compliant stocks, with a hard deadline to submit final compliance verification audits to the federal registry before July 25, 2026.