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Copenhagen70

Global product supply

With over 120 years of pharmaceutical industry experience, we are a leading developer, manufacturer, and supplier of fermentation-based anti-infective Active Pharmaceutical Ingredients (APIs).

Copenhagen21

Our customer

We are a customer and patient-focused organization and we aim to provide quality anti-infective products, offer world-class delivery services, and meet the demands of the entire product supply chain.

Our expert teams are also dedicated to managing the needs of our customers, directing operations from our distribution hubs or integrated 3PLs to ensure timely supply, enabling us to offer the highest level of agility to our customers.

Copenhagen3

Finished Dosage Forms (FDFs)

We offer a range of Finished Dosage Forms (FDFs) to the B2B sales channel via carefully selected CMOs. Through our quality management system, we ensure that our CMOs operate within compliance in their manufacturing and supply chain processes.

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.

Copenhagen63

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.

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Our 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 to provide high-quality products to our customers.

Our expert teams are dedicated to collaborating 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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Quality is in our DNA

Quality is embedded in every aspect of our business and the way we support our internal and external customers. From development through manufacturing, distribution, and customer service, we ensure our quality standards are met.

Our quality policy

Quality is managing and meeting expectations. At Xellia, we are committed to quality in everything we do, and we take pride in supplying quality products and services.

Quality is embedded in our systems and processes. Regulatory compliance is the foundation of our quality system, which is based on quality risk management and continuous improvement.

Our commitment is to comply with all regulatory requirements and continuously improve the effectiveness of our Quality Management System.

Our quality mindset

Having a strong Quality mindset is reflected in our systems, processes, and company culture, keeping our employees, customers, and patients in focus.

We are proud to know that our clients choose us because of our quality products, quality services, and good compliance level.

Our Quality Management System (QMS)

  • Validated processes and equipment

  • Standard Operating Procedures

  • Established methods for analysis and testing

  • Continuous improvement and lifecycle management to keep processes and methods up to date

Quality oversight and compliance status

Compliance is the foundation of quality in our products and services:

  • The Quality Unit (QU) is an independent function headed by the Chief Quality Officer.

  • Our global Quality function is responsible for providing strategic quality oversight through the Quality Management System (QMS) and Global Quality Strategy.

  • Our Quality teams in the sites ensure compliance with 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.