Vietnam's pharmaceutical industry is in the process of shifting its factory chain from WHO-GMP to higher international standards such as EU-GMP, JAPAN-GMP, PIC/S-GMP and US-FDA. However, the pace is still slow, and the technical picture is clearly differentiated with only 10% - or 25/240 factories - meeting high standards.
DHG Pharma currently owns 2 factories that meet JAPAN GMP and EU‑GMP standards.
Owning 2 factories JAPAN-GMP and EU-GMP, DHG Pharma is currently a model of standardization, creating momentum for the industry to develop towards "domestic drugs with international quality". Mr. Tomoyuki Kawata - Deputy General Director in charge of Production, Supply Chain and Technology Transfer of DHG Pharma had the opportunity to discuss in more depth about the "quality maintenance machine" behind each pill.
How do you evaluate the technical standard gap between pharmaceutical enterprises today?
Mr. Tomoyuki Kawata: Building a JAPAN GMP and EU-GMP factory not only requires 1.5-2 times more investment capital and 2-3 times longer approval time than WHO-GMP, but also requires a highly qualified technical team and strict operating procedures to be re-certified every 3-5 years. This is the main reason for the current large technical gap in the pharmaceutical industry.
However, I believe that the gap will gradually be narrowed. Technical standards determine the quality control capacity of each pharmaceutical company. Vietnam is currently creating many incentive mechanisms for research and production of drugs to replace imports, giving priority to domestic drugs that meet high standards in hospital bidding... so that businesses can orient their sustainable investments.
Mr. Tomoyuki Kawata - Deputy General Director in charge of Production, Supply Chain and Technology Transfer - head of the "quality maintenance apparatus" of DHG Pharma
What has DHG Pharma done in the past to maintain quality in a competitive price environment?
Since 2019, DHG Pharma has continuously improved the technical standards of its factories, aiming to create products of superior quality. Currently, we own 150 products that meet JAPAN-GMP and EU-GMP standards, 53 products that are bioequivalent out of a total of more than 300 products.
In the context of price competition, the biggest challenge for the technical team is how to maintain the highest quality while optimizing costs. We have solved this problem by promoting automation, streamlining processes, risk management and digitalization in quality management. The important thing is to never compromise on quality, because that is the core value that has created consumer trust for the past 51 years.
At the same time, DHG Pharma is promoting the development of new products and transferring production technology of famous products from Taisho Group (Japan), in order to enhance domestic competitiveness with a differentiated product system. In 2024, the company was granted registration numbers for 23 new products and deployed production of 13 new products. Technology transfer projects include sprays for treating allergic rhinitis, nasal polyps, and innovative drugs for treating diabetes, etc.
DHG Pharma factory produces nearly 5.2 billion units of high quality products
DHG Pharma Factory What technologies are currently being applied to improve production capacity and control product quality?
In 2024, DHG Pharma's Non-Betalactam and Betalactam factories produced nearly 5.2 billion units of high-quality products to serve the market. This impressive capacity comes from many factors deployed synchronously: automation technology, centralized data management platform, 3-shift continuous production process to reduce product changeover hours, etc.
At the same time, we have completed a strict quality control process from input materials to finished products, to ensure that each pill reaching consumers meets high standards. The company comprehensively implements clinical trials, cross-validation between departments, evaluation and storage of production batch records... to control all risks arising during mass production.
At DHG Pharma, quality control is not a final step, but a continuous assessment process throughout the supply chain in real time.
DHG Pharma proactively innovates technology and techniques to adapt to new challenges
As a "leading" enterprise promoting the upgrading of technical standards in the industry, what will be the next technological advances of DHG Pharma?
DHG Pharma is always proactive in innovating technology and techniques to adapt to new market challenges. For example, in the face of the problem of counterfeit drugs that is affecting the entire industry, we have deployed a traceability system via QR codes, applying blockchain to record the transportation - distribution process and post-circulation monitoring.
In the context of increasing competition from foreign drugs, DHG Pharma continues to invest in technology and products, maintaining quality and reasonable prices. In addition, the company also plans to expand production capacity, develop new products, transfer technology from international partners... In every step, DHG Pharma always ensures compliance with strict quality standards in the pharmaceutical industry.
Source: https://thanhnien.vn/duoc-hau-giang-ung-dung-cong-nghe-cao-chuan-quoc-te-trong-moi-vien-thuoc-viet-185250703102031005.htm
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