Pharmaceutical Ingredients
Cancer cases are globally on the rise, causing an increasing demand for their treatment. Highly Potent Active Pharmaceutical Ingredients (HPAPIs) are the key compounds for chemotherapies, combination therapies in particular. Business Line Pharmaceutical Ingredients at Heraeus Precious Metals specializes in the production of generic HPAPIs.
In 2021, Heraeus made a significant multi-million Euro investment building up its manufacturing capacity for platinum-based pharmaceutical ingredients to fight cancer. This is the company’s response to the global increase in demand for cancer drugs while consolidating its position as the global market leader for platinum-based active ingredients.
Generic HPAPIs
The high purity of our highly potent active pharmaceutical ingredients guarantees our customers effective processes and consistently top quality for their products. Continuous enhancement of our knowledge enables them to maintain compliance with changing regulations and ensures a long-term drug supply.
Quality Management
Extensive analytical capabilities, quality assurance and the full reliability of a global partner are extremely important for the pharmaceutical industry. Heraeus constantly secures the quality of its HPAPIs, follows strictly international regulations and prepares and maintains all documentation for initial and existing registrations worldwide.
Regulatory Affairs
A successful registration, based on transparent communication with clients and authorities, not only permits entry to markets all over the world, but also confirms that Heraeus meets the strictest regulatory requirements for its HPAPIs.
- Technical and scientific writing of dossiers
- Management of registration worldwide
- Collaboration with MAH during all registration stages
- Expertise in eCTD and specific regional requirements
Quality Assurance
Heraeus constantly ensures the top-quality of its HPAPIs and strives for continuous improvement in quality, safety, and environmental standards through its comprehensive services.
- Supervision of GMP compliance and quality standards
- Establishment of IT systems following GAMP guidance
- Professional handling of OOX and deviations
Quality Control
Heraeus is equipped with the most state-of-the-art analytical techniques: process controls, analysis of raw materials, intermediates, and release testing of HPAPIs are conducted in compliance with cGMP and ICH guidelines.
- State-of-the-art equipment
- Release & stability testing of HPAPIs in accordance with the guidance’s
- Microbiology testing laboratory
- Development & validation of methods
- Qualification of reference materials
