Asymchem's Dunhua facility passes first FDA inspection for API manufacturing
Asymchem announced its Dunhua 2 facility in China has successfully completed its first US Food and Drug Administration (FDA) inspection. The inspection focused on the continuous manufacturing process for active pharmaceutical ingredients (API).
Chinese pharmaceutical manufacturer Asymchem announced that its Dunhua 2 facility, specializing in carbapenem active pharmaceutical ingredients (API), has successfully passed its first inspection by the US Food and Drug Administration (FDA). The inspection, conducted between April 27-30, 2026, focused on the site's capabilities for continuous API manufacturing.
The Dunhua 2 facility, commissioned in 2020, utilizes continuous raw material feeding and reaction technology. Designed and built in-house by Asymchem, the site has tonnage-scale capacity for new chemical entities. According to Chairman and CEO Hao Hong, implementing continuous flow processes enhances operational safety and reduces the company's carbon footprint.
Asymchem, a global contract development and manufacturing organization (CDMO), maintains a strong track record with regulatory agencies. The company conducts approximately 200 customer audits annually and has completed over 100 regulatory inspections worldwide. Asymchem adheres to a Quality by Design (QbD) framework, emphasizing science- and risk-based approaches.
Founded in 1995, Asymchem offers integrated solutions for the pharmaceutical and biotech sectors. The company operates R&D and manufacturing sites in China, the US, and Europe, employing over 10,000 professionals globally.