CARBOGEN AMCIS Shanghai Site achieves successful outcome in Unannounced NMPA GMP Inspection 发布时间：2026-05-07 来源：CARBOGEN AMCIS INNOVATIONS AG

BUBENDORF, Switzerland, May 06, 2026 (GLOBE NEWSWIRE) -- CARBOGEN AMCIS, a Switzerland-based pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, today announces its Shanghai facility has successfully completed an unannounced Good Manufacturing Practice (GMP) inspection by China’s National Medical Products Administration (NMPA), with no observations.

The inspection, conducted on 14 April 2026, included a comprehensive on-site assessment of API manufacturing operations and the site’s Quality System. As part of the unannounced inspection, NMPA inspectors reviewed manufacturing processes, facilities, quality control laboratories, documentation practices and overall quality management systems.

The inspection concluded with no critical, major or minor observations. Inspectors also confirmed that no issues requiring formal explanation were identified at the close of the inspection. Recommendations were provided to support ongoing continuous improvement.

The positive outcome reflects the robustness of the site’s Quality System and the strength of its operational controls, with inspectors highlighting strong subject matter expertise, rapid access to documentation and alignment with regulatory expectations.

“This outcome reflects the high level of preparedness and expertise demonstrated by our Shanghai team, as well as the strength and maturity of our Quality System,” said Stephanie Schlienger, V.P. Quality & Compliance, of CARBOGEN AMCIS. “The successful completion of an unannounced inspection with no observations underlines our commitment to maintaining the highest GMP standards across all aspects of our operations.”

The Shanghai facility plays a key role within CARBOGEN AMCIS’ global network, supporting API manufacturing and process development activities. The successful inspection reinforces the site’s capability to deliver high-quality services in line with international regulatory requirements and supports the company’s continued growth in China and across global markets.

Stephan Fritschi, CEO of CARBOGEN AMCIS, added: “Successfully completing an unannounced NMPA inspection with no observations is a significant achievement and a strong validation of our global quality culture. It demonstrates our ability to consistently meet rigorous regulatory expectations and reinforces confidence in our Shanghai site as a reliable partner for our customers worldwide.”

CARBOGEN AMCIS (www.carbogen-amcis.com) is a leading service provider offering a portfolio of drug development and commercialization services to the pharmaceutical and biopharmaceutical industries across all stages of clinical development and product life cycle. Our integrated services and innovative chemistry solutions support timely and safe drug development, allowing customers to better optimise available resources. CARBOGEN AMCIS is a wholly owned subsidiary of Dishman Carbogen Amcis Limited, Ahmedabad, India.

For further information contact Lucie Framinet at lucie.framinet@carbogen-amcis.com or call +33 7 84 23 10 69

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/fb9efd55-1cdf-42ee-96bb-60d199a0683d