Pharmacosmos specialises in the production and supply of pharmaceutical grade carbohydrates.
For more than 60 years, we have led innovation in carbohydrates used as active pharmaceutical ingredients (API) or excipients in final formulations within medical, pharmaceutical, life science and biotechnology industries. Our products are recognised for meeting the highest standards of quality and safety and are sold in more than 50 countries around the globe.
We are the only US FDA and EU approved supplier of pharmacopeial carbohydrates, including our cryoprotective PentaHibe (pentaisomaltose) formulas.
Pharmacosmos complies with the highest current Good Manufacturing Practice (cGMP) requirements for human medicines. This is your assurance that all our products are of the highest quality and fit for their intended use.
We continuously optimise all relevant processes across production, documentation, control, and quality. And we validate and qualify our processes, equipment, and methods of analysis to ensure our products provide consistent quality, purity, safety, and efficacy, with minimum batch variation.
We also provide all the quality assurance documentation you need for the regulatory submission process, such as batch certifications, batch-to-batch reproducibility, toxicity reports, and access to US Drug Master files (DMF).
We are the only carbohydrate manufacturer certified by both the United States Food & Drug Administration (US FDA) and the European Directorate for the Quality of Medicines (EDQM).
Our facility and systems are inspected by national and international health authorities, including the Danish Medicines Agency (Lægemiddelstyrelsen) and the US FDA. And we do everything we can to exceed our customers’ expectations and monitor changing requirements to ensure the quality, safety and efficacy of our products.
From our ingredients to our waste management and power sources, we are working to ensure the environmental impact of our activities is kept to a minimum. The actions we take to protect and preserve nature are central to our daily business, and the production of PentaHibe.