Global Product Supply
With over 115 years of pharmaceutical industry experience, we are a leading developer, manufacturer and supplier of Active Pharmaceutical Ingredients (APIs) and Finished Dosage Forms (FDFs).
We invest heavily in both API and FDF capabilities, which means that we control the entire supply chain for most of our products. In addition to this, our in-house production capabilities are often backed up by trusted CMO capacities to create robust supply.
The customer
We are a customer and patient focused organization and we aim to provide the quality anti-infective products, offer world-class delivery services and meet the demands of the entire product supply chain.
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Finished Dosage Forms (FDFs)
We are continuously expanding our range of Finished Dosage Forms (FDFs), as well as our US and EU based manufacturing footprint. This includes our dry powder fill, freeze-dried vials, liquid fill products and in-house packaging and labeling.
Although our injectable products come in many varieties and can be produced by different manufacturing processes, we always ensure that we operate within compliance in our manufacturing and supply chain processes.
Learn more about our FDF sites:
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Active Pharmaceutical Ingredients (APIs)
We are well-known for being highly experienced in the development and production of difficult-to-manufacture anti-infective Active Pharmaceutical Ingredients (APIs). In particular, we are skilled in strain and fermentation development with bacteria and fungi. This includes advanced purification processes and final handling such as freeze-drying, spray-drying and micronization for semi-synthetic and fermentation derived products.
In addition to this, all of our key APIs are manufactured across multiple sites to ensure effective and reliable supply.
Learn more about our API sites:
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The supplier
We treat our suppliers as partners and believe that strong collaboration is crucial for long-term agile, cost effective and stable supply.
We require high standards in order to provide high quality products to our customers.
Our expert teams are dedicated to collaborate with our suppliers, be it a supplier of direct materials, technical and indirect materials and services or a Contract Manufacturing Organization (CMO), Contract Development Manufacturing Organization (CDMO) or Contract Research Organization (CRO).
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Compliance
Compliance is the foundation of quality in our products and services:
- The Quality Unit (QU) is an independent function headed by the Corporate Vice President, Global EHS & Quality
- Our global Quality function is responsible for providing strategic quality oversight through the global Management System (QMS), and Global Quality Strategy
- Our quality teams in the sites ensure compliance to the global procedures, GxP (cGMP, GDP and GLP), and relevant local laws and regulations
- Our sites are regularly audited by our experienced global lead auditors, customers and inspected by national health authorities
- We monitor/ audit the performance of our suppliers and partners, to ensure that we source from reliable and compliant partners
Throughout the years, we have consistently passed customer audits and authority inspections, clearly reflecting Xellia's strong focus on compliance.
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