One of the fastest ways to navigate the pharmaceutical approval process and generate positive cash flow is through the development of generic drugs. The USP and FDA offer blueprints, methods, and monographs that help accelerate regulatory acceptance. Popular generics include albuterol, fluticasone propionate, salmeterol, and combinations. The FDA also recently issued draft guidance for Beclomethasone Dipropionate, utilizing an IVIVC approach.
Beyond APSD and DDU tests, unique aspects of testing for Orally Inhaled and Nasal Drug Products (OINDPs) must be addressed. MSP, a Division of TSI, provides a complete range of equipment to perform essential tests such as dissolution, gravimetric analysis, spray force testing, and the “cold Freon” effect. These products are also available in the Copley catalog, offering comprehensive solutions for the unique demands of generic drug development.
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