Achieve Life Sciences Inc's Comment on Supply Chain
The company sources raw materials, active pharmaceutical ingredients (API), and finished drug products for clinical trials primarily through Sopharma and third-party contract manufacturing organizations (CMOs). Sopharma obtains cytisinicline from natural sources, specifically trees and shrubs of the Faboideae subfamily, which are harvested and processed annually. Although the seeds are naturally toxic, Sopharma's extraction process removes toxins to produce purified cytisinicline. CMOs acquire cytisinicline starting material from certain third-party suppliers. The cytisinicline API manufacturing process includes solvent extraction, recrystallization, filtration, and purification, with critical controls governed by internal specifications. Sopharma has developed and refined this process over many years and possesses significant expertise in cytisinicline production. The company plans to stockpile cytisinicline to meet projected commercial demand. Raw materials are generally available in adequate quantities; however, supply chain uncertainties may affect operations and financial results.
Achieve Life Sciences Inc's Comment on Supply Chain
The company sources raw materials, active pharmaceutical ingredients (API), and finished drug products for clinical trials primarily through Sopharma and third-party contract manufacturing organizations (CMOs). Sopharma obtains cytisinicline from natural sources, specifically trees and shrubs of the Faboideae subfamily, which are harvested and processed annually. Although the seeds are naturally toxic, Sopharma's extraction process removes toxins to produce purified cytisinicline. CMOs acquire cytisinicline starting material from certain third-party suppliers. The cytisinicline API manufacturing process includes solvent extraction, recrystallization, filtration, and purification, with critical controls governed by internal specifications. Sopharma has developed and refined this process over many years and possesses significant expertise in cytisinicline production. The company plans to stockpile cytisinicline to meet projected commercial demand. Raw materials are generally available in adequate quantities; however, supply chain uncertainties may affect operations and financial results.
Sources:
Achieve Life Sciences Inc 's official press releases and regulatory filings; CSIMarket.com's supply-chain research; and the financial filings and press releases of other companies cited in this report.
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