ST-CLOUD, France: The Ethypharm Group today announced that its facility located in Romford (Sussex, UK) has successfully passed its first U.S. Food and Drug Administration (FDA) inspection. Now waiting for the approval of its partner's marketing authorization, the site is gearing up to start supplying sterile pre-filled syringes (PFS) to the U.S. market by year end.
This successful FDA inspection confirms Ethypharm's longstanding reputation in maintaining quality systems fully compliant with the highest international standards.
"I'm very proud of this success which reflects the engagement of our teams, at both corporate and local levels, to supply patients with products of the highest quality standard," said Cécile PAILLOUS, Vice President Quality Group.
The Ethypharm Group launched two years ago an ambitious program of work to increase the capacity and capability of its Romford site (Essex, UK), to target a first move into the USA for its range of pre-filled syringe products. Having invested significantly in new facilities, equipment, processes and people, the Romford site hosted its first U.S. FDA inspection in February 2020. The Establishment Inspection Report (EIR) received on 28th July 2020 confirms the Good Manufacturing Practices (GMP) of the site and authorizes its sterile PFS unit to supply products for the U.S. market.
"This approval is an important strategic milestone for the Group which has invested 15M€ on the site in the last 2 years, with the support of our shareholders PAI Partners, in order to bring it to its full international potential," commented Bertrand DELUARD, President and CEO.
The site is now waiting for our partner to receive their product approval in the coming days or weeks and is geared to supply product to the USA before the year end.
About the Ethypharm Group
Ethypharm is a European pharmaceutical company focused on two therapeutic areas: the Central Nervous System and Critical Care. Ethypharm markets its drugs directly in Europe and China, and with partners in North America and the Middle East where its drugs are in high demand. The Group employs more than 1,500 people, mainly in Europe and China.
Ethypharm works closely with authorities and healthcare professionals to ensure the appropriate use of and access to its medicines, by as many people as possible.
For more information on Ethypharm, visit www.ethypharm.com and follow us on LinkedIn.
About Ethypharm's Romford manufacturing site
The manufacturing site located in Romford (Essex, UK) became part of the Ethypharm Group following the acquisition of Martindale Pharma in 2017. This site manufactures and supplies mainly sterile and oral medicines for both its home UK and international markets. Nearly 300 full-time and contract employees are employed on the site.
© Press Release 2020