Pharmaceutical Ingredients
Cancer cases are globally on the rise, causing an increasing demand for their treatment. Highly active pharmaceutical ingredients (APIs) are the key compounds for chemotherapies, combination therapies in particular. Business Line Pharmaceutical Ingredients at Heraeus Precious Metals specializes in the production of generic APIs.
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 one of the leading manufacturers for platinum-based active ingredients.
Generic API Portfolio
The high purity of our highly active pharmaceutical ingredients supports efficient customers processes and consistently high quality for their products. Continuous enhancement of our knowledge contributes to customers’ ability to maintain compliance with changing regulations and to long-term drug supply. Discover our API portfolio by selecting a product below.
Quality Management
Extensive analytical capabilities, quality assurance and the reliability of a global partner are extremely important for the pharmaceutical industry. Heraeus constantly secures the quality of its APIs, 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 demonstrates compliance with stringent regulatory requirements for its APIs.
- 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
To consistently maintain high quality standards for its APIs, Heraeus regularly reviews and improves internal standards and processes related to quality and safety.
- 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 state-of-the-art analytical techniques: process controls, analysis of raw materials, intermediates, and release testing of APIs are conducted in compliance with cGMP and ICH guidelines.
- State-of-the-art equipment
- Release & stability testing of APIs in accordance with the guidance’s
- Microbiology testing laboratory
- Development & validation of methods
- Qualification of reference materials
Highly Active Pharmaceutical Ingredients (APIs)
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