- Achieve Life Sciences has transferred cytisinicline manufacturing to Adare Pharma Solutions in Ohio and completed its first engineering batch.
- The company plans to resubmit its NDA in Q4 2026, with a potential product launch targeted for the first half of 2027.
Achieve Life Sciences has transferred manufacturing of its nicotine dependence treatment, cytisinicline, to Adare Pharma Solutions in the United States. The company confirmed that analytical method transfer to Adare’s facility in Vandalia, Ohio has been completed, ensuring testing procedures are qualified for quality control and regulatory compliance.
The company has also completed its first engineering batch of cytisinicline at the site. This initial manufacturing run is intended to support preparation for registration and eventual commercial-scale production. The move is part of Achieve’s broader strategy to establish a domestic manufacturing supply chain.
According to the company, the transfer reflects a focus on supply chain resilience amid evolving regulatory and market conditions. Achieve plans to resubmit its New Drug Application in the fourth quarter of 2026, naming Adare Pharma Solutions as its commercial manufacturing partner.
The U.S. Food and Drug Administration previously issued observations following a current Good Manufacturing Practice inspection at a third-party facility, which resulted in an Official Action Indicated classification. The company stated that these observations were general in nature and not specific to cytisinicline.
“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.”
Rick Stewart, Chief Executive Officer of Achieve Life Sciences
