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Skyepharma Identity in Facts and Figures
From 2017 to 2019, Skyepharma Production S.A.S. (Skyepharma) has itemised transformation into a full-service contract development and manufacturing organisation (CDMO) as a member of the Vectura Group.
The sector-by-sector breakdown provides a facts and figures statement of Skyepharma’s global capabilities, market reach and regulatory certifications, clarifying its new corporate identity as a CDMO with international reach.
Tracing its roots back to 1983 and founded under its current identity in 1996, Skyepharma Production now has almost 40 years accumulated experience in developing and manufacturing oral solid dosage forms.
Located near Lyon, in southern central France, the company currently employs some 150 people, with fully a quarter of whom work in research and development.
The 2016 merger between Skyepharma Plc and Vectura created Skyepharma Production as an entity to perform Oral Business Unit activities and marked the start of its journey to become a full service CDMO.
Skyepharma has steadily increased its manufacturing and logistics capabilities over recent years.
Available annual production capacities have now reached two billion tablets, 300 million capsules, 30 million blisters, six million bottles and 20 million stick-packs.
Furthermore, Skyepharma Production is now fully equipped for early stage development.
Skyepharma has now commercialised products across the EU, in North America, Latin America and Asia, with some 40% of products exported to the US market.
A further milestone was passed in January 2019, when the first batch of products was serialised and aggregated to meet US market regulatory requirements.
Skyepharma manufactures from facilities that meet international regulatory requirements, being EU certified for cGMP good manufacturing practice compliance and FDA approved since 1998, with latest inspection carried out in September 2019.
Since 2013, Skyepharma has also been recognised as an approved manufacturer by Anvisa, the Brazilian Health Regulatory Agency and registered at South Korea’s Ministry of Food and Drug Safety (MFDS).