Achieve Transfers Cytisinicline Production to Adare Pharma Solutions

Achieve Life Sciences Inc., a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence, has transferred cytisinicline manufacturing to U.S.-based Adare Pharma Solutions (Adare).

The analytical method transfer to Adare’s manufacturing facility in Vandalia, Ohio ensures that all testing procedures are fully qualified at the site, maintaining the highest standards of quality control and regulatory compliance.

Achieve’s first cytisinicline engineering batch has already been manufactured at Adare. This initial manufacturing run is a vital precursor to registration and, ultimately, production at commercial scales and volumes.

“The completion of the analytical transfer and the first batch now in the manufacturing site firmly positions Achieve to meet the goal of manufacturing cytisinicline drug product in the U.S.,” said Rick Stewart, CEO, Achieve Life Sciences. “This rapid progress reflects the sense of urgency for a strong domestic supply chain given the significant tariffs recently announced on imported pharmaceutical products and the growing imperative for supply chain resilience.”

“We are excited to have partnered with Achieve, reflecting our shared commitment to advancing transformative therapies and delivering meaningful impact for patients in need,” said Tom Sellig, CEO, Adare Pharma Solutions and member of the Achieve Board of Directors since 2023. “We are proud of what we have accomplished together thus far, and we remain deeply committed to supporting Achieve as their cytisinicline program progresses toward making a difference in patients’ lives.”

Achieve reiterates its expectation of a cytisinicline launch in the first half of 2027.