Pharmaceutical Ingredients

Pharmaceutical Ingredients specializes in the production of generic APIs (Active Pharmaceutical Ingredients) as well as the exclusive synthesis of cytotoxic compounds from the research stage to registration to market launch. Special conditions must be observed in handling these compounds, which must also be of the highest purity. With our passion for health, we have achieved an outstanding global position in the production of active pharmaceutical ingredients that contain precious metals.

All of our APIs are fully developed and manufactured at our parent site in Hanau/Germany. We have been US-FDA-approved for more than 25 years and have an excellent track record worldwide with all major Health Agencies.

Generic APIs

Heraeus has developed a range of key APIs for cancer therapy. As a long standing global supplier of generic APIs, we offer customers continuity and reliability. Our expertise in preparing registration documents guarantees a smooth path to market.

The high purity of our active pharmaceutical ingredients guarantees our customers effective processes and consistently top quality for their products. Continual further development of our knowledge enables them to maintain compliance with changing regulations and ensures a long-term drug supply.

  • Cisplatin
  • Carboplatin
  • Oxaliplatin
  • Dacarbazine
  • Thiotepa
  • Bendamustine hydrochloride monohydrate

You can find further information about our services, such as documentation and registration information, under “Services".

Custom Manufactoring

We support our customers in the exclusive synthesis of cytotoxic compounds from the research stage to registration to market launch. With these comprehensive services, our customers are free to focus on their core business and transform their innovative ideas into commercial products.

More than 30 years of experience in the field of cytotoxic APIs is the foundation of our exclusive contract manufacturing services:

  • Our high-containment systems ensure the highest technological standard.
  • Scientists and experts contribute extensive knowledge and experience to each project.
    • scale up from lab scale to commercial scale
    • GMP implementation
    • continuous process optimization
  • Our contract manufacturing includes batches from gram to 30 kg scale.
  • With comprehensive GMP documentation and outstanding global regulatory support we offer the full-service package.
  • We strictly protect our customers’ IP.

Please contact us if you need any further information or if you are interested in co-operating with us.

You can find further information about our services, such as documentation and registration information, under “Services".

Quality Assurance

Quality Assurance

Our Quality Assurance constantly ensures the outstanding quality of our active pharmaceutical ingredients and strictly follows international regulations. Our products and processes are developed and continuously adapted to current ICH guidelines in line with the international GMP and GxP requirements.

Heraeus’ quality standards and its Environmental, Health, and Safety Policy (EHS) fully meet the various increasing national and international requirements. We are organized in accordance with DIN EN ISO 9001:2008 and ISO 14001:2004.

Our team focuses on constantly improving quality, safety, and environmental standards. We consider a partnership with you to be a matter of full and long-term reliability. The highest quality of our APIs and services is at the core of our activities.

The implementation of instructions and processes always conforms to valid GxP standards. Regular and thorough audits by customers and inspections by national and international authorities (e.g. the FDA) validate Heraeus’ exceptional quality assurance system.

Regulatory Affairs

Regulatory Affairs

A successful registration, based on transparent communication, not only permits entry to markets all over the world; it also confirms that Heraeus meets the strictest requirements for the quality of its APIs.

Preparation of Dossiers

  • registration documents according to current ICH standards
  • all relevant pharmacopeias (e.g. Ph. Eur., BP, USP, JP, IP, CP)
  • chemical-pharmaceutical dossiers (CMC, Module 3): technical writing of the complete part - also based on customers’ raw data
  • CEPs available for all APIs with a pharmacopeial monograph
  • expertise in eCTD submissions and non-eCTD electronic submissions (NeeS)

Management of Registration Procedures

  • registration procedures consistent with current guidelines and predetermined timeframes
  • assistance in providing additional technical information
  • competent personal contact at all stages of the registration process

Life Cycle Management

  • regulatory support for existing products
  • continuous improvement of documentation
  • established change control system
  • professional change management with customers and authorities in line with the current Variation Regulations

Quality Control

Quality Control

Extensive analytical capabilities and the full reliability of a partner are extremely important to pharmaceutical clients worldwide. With more than 160 years of experience in quantitative precious metal analysis with the highest accuracy and some 30 years in API quality control, Heraeus is fully established in the performance of a wide range of the latest analytical techniques. All work on in-process control, raw materials, intermediates, and release testing of APIs is conducted according to GMP and ICH guidelines.

Our Services

  • comprehensive stability testing programs for both APIs and Finished Dosage Forms
  • fully characterized reference standards for all our APIs
  • analytical and technical support during development and commercial production at customers’ sites
  • identification of impurities and degradation products
  • Validated analytical methods, e.g. HPLC, GC, IC, FTIR, UV, ICP, DSC, TGA, KF, AAS, XRD
  • advanced analytical technologies, such as UPLC, HPLC-MS, ICP-MS and Raman spectrometry
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