Focus on systematic development of value-generating products within our 505(b)(2) and Generics development portfolio.
Efforts targeted at continued expansion into complex dosage forms, multiple therapeutic classes, high barrier-to-entry, and difficult-to-formulate products.
NDA’s and ANDA’s for products that range in various dosage forms including tablets, capsules, oral solutions, suspensions, powders, creams, and ointments.
ANALYTICAL
Development
Full release and stability test methods for new materials and products
Method validation and qualification as required by cGMPs
Method transfers, as required
Laboratory investigations as required by CAPAs, RCAs and cGMPs
Detailed testing for improved accuracy and reduced costs
