The Ethypharm Group announced its facility located in Romford 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.
"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 a program of work to increase the capacity and capability two years ago at its Romford site (Essex, UK), to target a first move into the USA for its range of pre-filled syringe products. 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," said Bertrand DELUARD, President and CEO.
The site is now waiting for its partner to receive product approval and is geared to supply product to the USA before the year end.