Hataphar’s High-Tech Plant Receives GMP Certification from the Drug Administration

On June 14, 2024, Hataphar’s High-Tech Pharmaceutical Plant officially received the “Good Manufacturing Practices for drugs and drug ingredients” (GMP) certification from the Drug Administration – Ministry of Health.

This achievement recognizes the continuous efforts of the leadership and employees of Hataphar’s High-Tech Pharmaceutical Plant – Hataphar Healthcare. The GMP certification marks a new milestone in Hataphar’s journey towards becoming the first company in Vietnam to successfully produce original brand-name drugs by 2030.

Aiming to maintain its leading position in product quality, Hataphar has been collaborating with ASKA Pharmaceutical—a top 20 Japanese pharmaceutical company with 100 years of experience—since January 2022 to construct the Hataphar High-Tech Pharmaceutical Plant according to PIC/s – Japan GMP standards. The project commenced in January 2022 with a total phase 1 investment of over 820 billion VND. After nearly two years of construction on more than 45,000 square meters of land in the Hoa Lac High-Tech Park, Hanoi, the plant has completed phase 1 with all key facilities in place.

Recognized as one of the largest pharmaceutical manufacturing plants in Vietnam, the Hataphar High-Tech Plant is equipped with the most advanced systems in the pharmaceutical manufacturing industry, including an EMS system for monitoring temperature, humidity, and pressure differentials online throughout the plant; a formula weighing system; a network CDS chromatography control software; along with various document storage and data integrity systems to support drug quality inspection and control.

With a large team of Japanese personnel from strategic partner ASKA (such as the plant manager, R&D department head, etc.), DHT has received support in design, training, operation, research, development, and technology transfer. The Hataphar High-Tech Plant is expected to achieve Japan GMP standards by 2025 and soon begin commercial production with a designed capacity of 2 billion product units per year.

In addition, DHT is in discussions and negotiations with ASKA about collaborating on the registration and production of the original brand-name drug Prostal for distribution in Vietnam, as well as producing Levothyroxine thyroid hormone medication, with an annual output of hundreds of millions of tablets for export back to Japan.

With the investment in the new plant and a team of experienced and passionate personnel, Hataphar is committed to prioritizing the health of the people by providing the highest quality products at the most reasonable prices, meeting the needs of both the domestic and international pharmaceutical markets.