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Mark Dobish Email
Senior Manager, Program Management and External Manufacturing . Purisys
Athens, GA
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Employees:
25Revenue:
$5MAbout
Purisys is a global leader in custom synthesis of active pharmaceutical ingredients and advanced intermediates. We support pharma & biotech companies with APIs, reference standards, controlled substances, cannabinoids and cGMP clinical & niche commercial CDMO services. Formed as a spin-off from Noramco in 2019, Purisys began manufacturing in 1979 as part of Johnson & Johnson. WORLD LEADER IN PHARMACEUTICAL CANNABINOIDS & CANNABINOID REFERENCE STANDARDS Purisys produces 50+ major and minor cannabinoids, as well as degradants, metabolites & analytical standards to support our customers in this growing field. We have Drug Master Files for multiple compounds, including Dronabinol (DMF#20682), CBD (DMF# 33223), Nabilone (DMF# 35408), and have produced other cannabinoids used worldwide in IND/IMPD/NDA/ANDA filings. CUSTOM API and DRUG DEVELOPMENT & MANUFACTURING (CDMO) SERVICES FOR PHARMA & BIOTECH For clients seeking preclinical-to-commercial APIs, we provide comprehensive development, analytical and manufacturing services - including full-service clinical-to-commercial small volume & orphan drug commercial API synthesis in our FDA-inspected GMP manufacturing suites. Our custom synthesis projects include difficult-to-manufacture APIs (controlled substances, injectable-grade APIs, HPAPIs and environmentally sensitive APIs). IN-STOCK REFERENCE STANDARDS AND CUSTOM SYNTHESIS SERVICES Purisys stocks 250+ reference standards with structural elucidation and comprehensive analytical data. We ship reference standards to 30+ countries on 6 continents. We can perform rapid standards development & qualification – including custom synthesis of degradation products, metabolites and other impurities. CAPABILITIES: • Pharma grade cannabinoid APIs & reference standards • In-stock standards; custom synthesis & qualification • Excipient compatibility & formulation & solid state • cGMP manufacturing • Custom API, high potency API & labile molecule development • Method developmentPurisys Address
1550 Olympic DrAthens, GA
United States