Having started with generic platinum based APIs –where Heraeus is the largest producer worldwide - Heraeus developed a variety of purely organic anti-cancer compounds. Today, we manufacture organic as well as metal based highly potent APIs for the generic industry or under exclusive contracts.
For broadening our production capabilities, we have set up a unique commercial fermentation facility (incl. state of the art downstream facilities) for highly potent anti-cancer APIs at our Hanau site. All development and production facilities as well as the technical infrastructure meet highest standards of staff, product and environmental protection.
Besides development and synthesis of generic products, it is another important approach to cooperate with our customers on development, upscaling and documentation needed for branded APIs.
Our dedicated engineering team employs experts for the plant layout, installation and commissioning of complex manufacturing facilities.
All activities are supported by a regulatory affairs group. Depending on our customer requirements, we compile high-quality registration dossiers in CTD-format and others to be used for national procedures, European procedures or ANDAs.
The quality assurance department secures the outstanding and constantly high quality of our active pharmaceutical ingredients. Our products and processes are developed according to current ICH- guidelines, corresponding to the needed FDA, Japanese and EU requirements.
The operational and organisational structure of our department is in accordance with the requirements defined in DIN EN ISO 9001. Our vision to continuously improve the quality standards is encouraged by regular inspections through competent authorities (for example the FDA), our customers and relevant certifying bodies. The quality assurance system as well the GMP conform translation of instructions and processes are in accordance with valid standards and can be adapted within legal frames to the demands of our customers. Our biotechnologically produced active pharmaceutical ingredients are certified by a qualified person.
For our business extensive analytical capabilities and reliability are of great importance. A specialised group within the analytical department is dedicated to quality control of pharmaceutical materials with more than 25 years experience. All work on in-process control, raw material, intermediate and API release testing is being conducted in accordance with cGMP guidelines and ICH guidelines. To ensure objective service and data, the quality control acts independent from business unit pharmaceutical ingredients.
Our generic portfolio includes:
Carboplatin, Cisplatin, Oxaliplatin, Dacarbazin, Thiotepa, Epirubicin and Idarubicin.
Contract development and manufacturing of new chemical entities (NCEs) and niche generics represent an increasing part of our business. We welcome exlusive cooperations throughout all phases of a product’s life cycle.