Ministry of Health announces list of 46 foreign pharmaceutical companies with drugs violating quality

The Drug Administration of Vietnam (Ministry of Health) has just announced the 42nd batch of lists of foreign drug manufacturing facilities that have drugs that violate quality standards and must continue to sample and test 100% of imported drug batches.

In Decision No. 4318 dated December 2 of the Drug Administration of Vietnam sent to the Department of Health of provinces, cities and drug importing companies, it is stated that implementing the provisions in Article 9 of Circular No. 30/2025/TT-BYT dated July 1, 2025 of the Ministry of Health on announcing, updating and removing names from the List of manufacturing facilities with drugs violating quality;

Based on the results of monitoring the quality of drugs in circulation and reviewing establishments with violating drugs and foreign drug manufacturing establishments that are eligible to be removed from the list of those required to take samples for quality testing of 100% of imported drug batches, the Drug Administration of Vietnam announces the publication of Phase 42 - List of foreign companies with drugs violating quality and required to take samples for quality testing of 100% of imported drug batches (pre-inspection).

Accordingly, in this list, Indian enterprises continue to be the country with the largest number of violating enterprises. A series of companies that appeared from 2013-2015 to date are still kept under pre-inspection.

List of 46 foreign pharmaceutical companies with drugs violating quality updated to November 13, 2025. Screenshot of the website of the Drug Administration of Vietnam.

In addition to the large group from India, many businesses from Bangladesh, China, Indonesia, South Korea, Pakistan, the US, Italy and Romania also continue to be under special supervision. Reman Drug Laboratories of Bangladesh, CSPC Zhongnuo of China, PT. Merck Tbk of Indonesia or Crown Pharm and Yuyu Inc. of South Korea have all been announced to have violated very early, but have not yet met the requirements to have the pre-inspection measure lifted.

In this list, there are 2 American companies such as ADH Health Products and Robinson Pharma, which have both pre-inspection and post-inspection quality violations.

The common point of all 46 companies is that they all have imported drugs into Vietnam that do not meet quality standards, requiring the products to be strictly monitored before being circulated.

In addition to the list of violations, the Drug Administration also said that 98 companies from 16 countries were removed from the monitoring list after completing the pre-inspection period and no new violations occurred.

The Drug Administration of Vietnam requests the Department of Health of provinces, cities, and health sectors to direct drug management, inspection, and testing units under the Department to conduct inspections and supervision of compliance with regulations on quality inspection of imported drugs in circulation in the management area and handle organizations/individuals who violate according to current regulations.

Source: https://suckhoedoisong.vn/bo-y-te-cong-bo-danh-sach-46-cong-ty-duoc-nuoc-ngoai-co-thuoc-vi-pham-chat-luong-169251203151356603.htm