Commercial Manufacturing

When you need a reliable partner to commercially manufacture your drug product, we can help. We offer commercial manufacturing capabilities, including NDA and ANDA products, as well as 505B2 and CBE30 filings. We have DEA license for Controlled Drugs (II-V). Plus, our scalable manufacturing equipment allow for process trains to meet every batch size. Our niche markets include Orphan products along with our niche in containment manufacturing.

Commercial batch sizes of solids can range from 100 kg - 500 kg (<50M units per annum)

Commercial batch sizes of liquids can range from up to 350L (automated liquid-filling line)