Built from the alliance of four established contract-pharmaceutical companies, Aphena Pharma Solutions manufactures and packages products for pharmaceutical, medical-device, biologics and consumer-health markets. Its two FDA-registered U.S. operations pair solid-dose work in Tennessee with liquid and topical manufacturing in Maryland, giving the company 762,000 square feet of facilities and more than 450 employees. Aphena is also DEA licensed for controlled substances and certified to ISO 13485:2016 and ISO 9001:2015 standards.
FDA Registered (21 CFR Parts 210, 211, 820)
Registration
DEA Licensed (Schedules CII–V)
Registration
cGMP Compliant
Compliance program
ISO 13485:2016
ISO 9001:2015
UL Certified
FDA
Quality certification
DEA
Quality certification
UL
Quality certification