Asymchem's Carbapenem API Production Facility Successfully Completes First FDA Inspection

Global contract development and manufacturing organization (CDMO) Asymchem announced that the carbapenem active pharmaceutical ingredient (API) manufacturing facility within Jilin Asymchem Pharmaceuticals Co. Ltd. has successfully completed its initial inspection conducted by the US Food and Drug Administration (FDA).

Asymchem, which provides contract development and manufacturing services to the pharmaceutical sector on a global scale, announced that the Dunhua 2 (DH2) facility, focused on carbapenem API production, has passed an important regulatory milestone.

The FDA inspection, conducted between 27-30 April 2026 as part of a short-notice Pre-Approval Inspection (PAI), was carried out to support a commercial API manufacturing process using continuous feedstock and reaction technology. The inspection represents the first significant regulatory assessment for the DH2 carbapenem manufacturing facility, which became operational in 2020.

High-Capacity API Solutions with Continuous Manufacturing Technology
Asymchem's DH2 facility provides specialized carbapenem intermediate products and API solutions for use in different stages from clinical development to commercial production.

The facility, designed and established by the company's engineering teams, employs advanced continuous-flow ozonolysis technologies. This infrastructure provides production capacity reaching ton scale, which supports the development of new chemical entities (NCEs).

Asymchem notes that continuous-flow technology not only provides efficiency and safety advantages in manufacturing processes; it is also an important part of the company's sustainability goals aimed at reducing its carbon footprint.

Global Experience in Quality Standards
Asymchem Group Board Chair and CEO Dr. Hao Hong stated that the first FDA inspection conducted at the DH2 facility is an important step demonstrating the company's commitment to high quality standards.

Hong noted that Asymchem is proud to continue the experience it has gained in processes conducted with regulatory authorities in the United States, European Union, Japan, China, Australia, South Korea, Canada, Brazil and other global markets.

Quality-Focused Manufacturing Approach
Asymchem announced that across its global operations it undergoes approximately 200 customer inspections annually and has successfully completed more than 100 regulatory inspections to date.

The company adopts a Quality by Design (QbD) approach to strengthen quality management throughout the product lifecycle. Supported by scientific and risk-based assessments, data-driven decision-making processes and integrated control strategies, this approach aims to enhance quality and reliability in Asymchem's manufacturing processes.

Successful completion of the FDA inspection strengthens Asymchem's role in the global pharmaceutical supply chain, while also demonstrating the company's competency in commercial API production with advanced manufacturing technologies and high quality standards.

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