Équipements de développement pour médicaments génériques

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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 Another recent generic draft guidance from the FDA is Beclomethasone Dipropionate, utilizing an IVIVC approach.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.