CARBOGEN AMCIS AG. has successfully completed U.S. FDA inspection of its facility in Aarau, Switzerland

Switzerland-based CARBOGEN AMCIS AG., a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, announces the completion of a U.S. Food and Drug Administration (FDA) inspection at the site in Aarau, Switzerland.

The pre-approval FDA paper inspection for an intermediate product from a customer was conducted from 17 August - 15 September 2021. By receiving the result in October 2021 the inspection was concluded successfully with no findings, confirming that no on-site inspection is required at the Aarau site for this product.

The product manufactured at the Aarau facility will be processed into the final drug that the customer expects to be approved in the USA in November 2021.

"This positive inspection result from the FDA is a demonstration of our team's commitment to the highest level of quality. This result continues a series of positive inspections by the FDA at CARBOGEN AMCIS AG. reinforcing our successful audit history. I would like to congratulate everyone for the great effort and thank our customer for their trust in our company." said Mark Griffiths, Dishman Carbogen Amcis Limited, Director (Global Marketing & Strategy).

Opened in 1994, the Aarau facility has the flexibility to accommodate a wide range of projects, be it API or analytical. The site is centrally located in Switzerland between Zurich, Basel and Lucerne, 38km away from the headquarters in Bubendorf.

• Total of 16 vessels from 16 L to 630 L
• Swiss Medic approved site
• Fully cGMP compliant
• Specialized Chromatography Group
• Strong Analytical Capabilities & Specialties Lab

Shares of Dishman Carbogen Amcis Limited was last trading in BSE at Rs. 216.70 as compared to the previous close of Rs. 207.30. The total number of shares traded during the day was 48217 in over 1310 trades.

The stock hit an intraday high of Rs. 218.55 and intraday low of 207.00. The net turnover during the day was Rs. 10263675.00.

Source : Equity Bulls

Keywords

DishmanCarbogenAmcis INE385W01011 DCAL Pharmaceuticals API USFDA Inspection