Asymchem's Dunhua 2 Manufacturing Site Achieves First FDA Approval for Continuous API Production

Asymchem's Significant Milestone in Carbapenem Production

Asymchem, a prominent global contract development and manufacturing organization (CDMO), has reached a noteworthy milestone with its Dunhua 2 (DH2) facility located in Tianjin, China. On June 22, 2026, the site completed its first Pre-Approval Inspection (PAI) by the US Food and Drug Administration (FDA), a critical step for its continuous manufacturing of carbapenem active pharmaceutical ingredients (APIs).

The PAI, undertaken between April 27-30, 2026, was part of the regulatory pathway for bringing a commercial API to market using innovative continuous raw material feeding and reaction technologies. This achievement is particularly significant as it marks the first regulatory validation for the DH2 facility, which officially commenced operations in 2020. Asymchem's investment in this dedicated manufacturing site illustrates its commitment to producing high-quality pharmaceutical ingredients.

The DH2 facility specializes in providing custom carbapenem intermediates that support the transition from clinical to commercial supply chains. One of the standout features of this site is its advanced continuous flow ozonolysis capabilities, a cutting-edge technology designed and implemented by Asymchem's in-house engineering teams. This system allows for high-capacity production in tonnage scales, essential for new chemical entities (NCEs).

Implementing continuous flow technology is a priority for Asymchem, as it enhances operational safety and contributes to a reduced carbon footprint, aligning with global sustainability goals. Dr. Hao Hong, Chairman and CEO of Asymchem Group, expressed pride in the company’s ongoing success in gaining regulatory approvals from agencies across the world, including the U.S., European Union, and various countries in Asia and South America.

"This first FDA inspection of Asymchem's Dunhua 2 facility underlines our steadfast commitment to excellence in quality standards," said Dr. Hong. The company maintains a rigorous approach to quality assurance, completing approximately 200 customer audits each year and over 100 regulatory inspections to date.

Asymchem adheres to a comprehensive Quality by Design (QbD) framework, which fosters scientific and risk-based solutions, data-driven decision-making, and integrated control strategies. This methodology enhances the consistency and reliability of its production processes, ensuring that products meet the highest compliance and safety standards.

Founded in 1995, Asymchem has established itself as a leader in the CDMO space, offering integrated solutions geared toward the pharmaceutical and biotech industries. With extensive research and development and manufacturing facilities located in China, the U.S., and Europe, the company employs over 10,000 professionals and provides a wide range of services, extending from small molecules to biologics and synthetic biology.

Asymchem's ongoing dedication to innovation in pharmaceuticals is evident in its investments in both advanced technologies and sustainable practices, which together create added value for its global clientele. For anyone looking for comprehensive pharmaceutical manufacturing solutions, Asymchem remains a formidable partner poised to elevate standards and deliver quality outcomes.

For further information regarding Asymchem's capabilities and service offerings, visit their official website at www.asymchem.com.