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Contract Manufacturing | Overview
Overview
ANI Pharmaceuticals is an experienced contract manufacturer. Since inception in 2004, we have been contract manufacturing for long term partners.
With over 170,000 sq. ft. of manufacturing and our diverse packaging capability, ANI is able to manufacture and package most oral
dosage forms. We have expertise in liquid solution and suspension forms, topical liquids, tablets, both coated and non-coated, as well as capsules.
ANI also has unique capability for manufacturing products in a containment space such as hormones. Our state-of-the-art facility is fully automated
and meets or exceeds requirements for operator safety. EPA requirements are monitored with electronic back-up systems in place. In addition, ANI has
added controlled substance handling capability to our portfolio. In 2008 a new cage and vault were approved by DEA for working with up to Class II
controlled substances.
Our technical team comprised of manufacturing, technical transfer and quality professionals will work with you to prepare a technical transfer plan.
We work with a 44 point outline of required activity that begins with site specific stability data risk assessment and ends with a final technology
transfer report upon completion.
Our typical process includes assessment and feasibility, material qualification and testing, development lot, accelerated stability, validation and
ultimately commercialization. We will work with your Regulatory team to support your filing strategy.
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