With 20 years of expertise in chemical synthesis, DempoChem provides over 50 generic APIs focusing on cardiovascular, diabetes, and CNS therapies. Our manufacturing facilities are equipped with flow chemistry and high-containment suites (OEL < 1μg/m³) to maximize production efficiency and safety. We strictly adhere to ICH Q7 guidelines and maintain full cGMP compliance, guaranteeing consistent product quality and a highly reliable supply chain from intermediates to commercial scale.
DempoChem partners with innovators to navigate complex drug development, offering end-to-end CDMO services from novel intermediate design to commercial API manufacturing. Our expertise in handling potent compounds and sensitive reactions supports both early-stage feasibility studies and late-phase process validation, aligning with global pharmacopeia standards to bridge lab-scale innovation with market-ready production.
Building on decades of process chemistry mastery, we deliver adaptive manufacturing solutions for niche therapies and mainstream generics alike. Specialized containment technologies and modular production suites enable seamless scaling from gram-scale preclinical batches to metric-ton commercial campaigns, while maintaining full ICH Q7 compliance across hazardous material handling and purification operations.
DempoChem integrates quality-by-design principles with ICH-aligned quality systems, ensuring APIs consistently meet USP/EP monograph specifications. Our cross-functional teams of synthetic chemists and process engineers deploy continuous manufacturing platforms with in-line PAT monitoring, achieving first-time-right process validation rates that accelerate regulatory submissions. With active DMF/ASMF filings across FDA, EMA, and PMDA jurisdictions, we maintain audit-ready facilities capable of supporting clinical-stage formulations through to global market authorization.
Tell us what you need to make, source, or scale. Our team will route your request to the right specialist.