EUROAPI: Progressive restart of prostaglandin production at Budapest site
Progressive restart of prostaglandin production at EUROAPI’s Budapest site on January 19, 2023
Successful implementation of EUROAPI’s remediation plan
Majority of prostaglandin production expected to be back online by Mid-April 2023
PARIS, January 31, 2023--(BUSINESS WIRE)--Regulatory News:
EUROAPI (Paris:EAPI) progressively restarted prostaglandin production at its Budapest site on January 19.
As communicated to the market in its press release of December 7, 2022, EUROAPI identified certain Good Manufacturing Practices deficiencies related to production documentation during an internal assessment and decided, out of an abundance of caution, to proactively and temporarily suspend prostaglandin activities at its Budapest site. The Group has built and successfully implemented a comprehensive remediation plan, allowing to progressively restart prostaglandin production in January. As the restart is progressive in nature by design, EUROAPI expects the majority of prostaglandin production to be back online by Mid-April 2023.
As anticipated, no other activities at the Budapest site were impacted, including Contract Development and Manufacturing Organization (CDMO) activities.
As transparency and quality are the Group’s highest priorities, EUROAPI has been keeping the relevant health authorities as well as its clients and partners informed.
EUROAPI is focused on reinventing active ingredient solutions to sustainably meet customers’ and patients’ needs around the world. We are a leading player in active pharmaceutical ingredients with approximately 200 products in our portfolio, offering a large span of technologies, while developing innovative molecules through our Contract Development and Manufacturing Organization (CDMO) activities.
Taking action for health by enabling access to essential therapies inspires our 3,350 people every day. With strong research and development capabilities and six manufacturing sites all located in Europe, EUROAPI ensures API manufacturing of the highest quality to supply customers in more than 80 countries. EUROAPI is listed on Euronext Paris; ISIN: FR0014008VX5; ticker: EAPI). Find out more at www.euroapi.com and follow us on LinkedIn.
Certain information contained in this press release is forward looking and not historical data. These forward-looking statements are based on opinions, projections and current assumptions including, but not limited to, assumptions concerning the results of the Group’s internal assessment of the prostaglandin production process and ongoing and future assessments and actions potentially taken by regulatory authorities, as well as the Group’s current and future strategy, financial and non-financial future results and the macroeconomics and business environment in which the Group operates, as well as events, operations, future services or product development and potential. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Forward looking statements and information do not constitute guarantees of future performances, and are subject to known or unknown risks, uncertainties and other factors, a large number of which are difficult to predict and generally outside the control of the Group, which could cause actual results, performances or achievements, or the results of the sector or other events, to differ materially from those described or suggested by these forward-looking statements. These risks and uncertainties include those that are indicated and detailed in Chapter 3 "Risk factors relating to the issuer" of the prospectus approved by the French Financial Markets Authority (Autorité des marchés financiers, AMF) on March 31, 2022, under number 22-076. These forward-looking statements are given only as of the date of this press release and the Group expressly declines any obligation or commitment to publish updates or corrections of the forward-looking statements included in this press release in order to reflect any change affecting the forecasts or events, conditions or circumstances on which these forward-looking statements are based.
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