Highly Potent API Services

The Dishman Group offers unparalleled capability in scale-up, development and commercial manufacture of highly potent compounds and vitamins.

The Dishman Group provides state-of-the-art containment services. All of our facilities operate to current Good Manufacturing Practice (cGMP) and can produce material for preclinical testing, clinical trials and commercial use.

In 2012 our facilities successfully underwent a number of inspections from recognized Health Authorities: the facility in The Netherlands, was inspected by the US Food and Drug Administration (FDA) and the Dutch Medicines Evaluation Board (MEB); our Swiss subsidiary CARBOGEN AMCIS was inspected by Swiss Medic, the FDA, by the French Health Authorities (ANSM) and received an accreditation as foreign manufacturer for Japanese market; and our facilities in India were inspected by the FDA, the Australian Therapeutic Goods Administration (TGA) under a Mutual Recognition Agreement (MRA) with the European Directorate for the Quality of Medicines & HealthCare (EDQM), the World Health Organization (WHO) and the Korea Food and Drug Administration (KFDA).

All of our containment facilities are designed based on a containment concept utilizing barrier isolation technology as well as a strict zone concept with pressure cascades, airlocks and access controls. This allows the safe handling of highly-potent compounds of all categories including cytostatics/cytotoxics.

We offer services starting from laboratory scale for process research and development purposes up to large scale manufacturing on 8000 L scale including category IV compounds (OEL < 1µg/m³), the highest category in our categorization system.

To support the Active Pharmaceutical Ingredient (API) development process through all stages, a variety of high-containment analytical and purification capabilities complement the chemistry service portfolio.

Highly Potent API Services

News

11 August 2016
Dishman Celebrates a Decade of Success Since Acquisition of CARBOGEN AMCIS

2 February 2016
Dishman Netherlands awarded for its Corporate Social Responsibility.

24 September 2015
Dishman has been awarded manufacture of SIRTURO® (bedaquiline) API

9 February 2015
Successful FDA inspection at the Netherlands Dishman site

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