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Streamline Generic Drug Development

Accelerate the approval process and boost cash flow by developing generic drugs.

Generic Drug Development Equipment

The USP and FDA provide blueprints for many methods and monographs to assist in accelerating regulatory acceptance.

To name just a few, there are well known and accepted generics for albuterol, fluticasone propionate, Salmeterol, or combinations. Another recent generic draft guidance from the FDA is Beclomethasone Dipropionate, utilizing an IVIVC approach.

There are also unique testing aspects to OINDPs that are outside of the focus of APSD and DDU tests. MSP, a Division of TSI, carries a full equipment set to perform dissolution testing, gravimetric testing, spray force testing, and testing the “cold Freon” effect.

Legacy Impactors

Legacy cascade impactors and impingers are used to replicate existing test methodologies, expand lines, and create generics from branded drugs using prescribed methods or monographs.