Your 505(b)(2) project has tremendous potential, but finding the right active pharmaceutical ingredient manufacturer is complicated. The landscape is crowded, and you face increasing competitive pressure to get to market first. LGM Pharma’s dedicated API sourcing team has been working with clients for years on the 505(b)(2) regulatory pathway and is currently supporting 100+ such programs across a wide range of therapeutics and at every stage.
With in-house CDMO capabilities we can take your 505(b)(2) and other drug manufacturing projects all the way from API selection through R&D to commercialization.
Your 505(b)(2) can move quickly at LGM, where we offer a broad range of dosage forms, formulation and regulatory expertise, analytical testing, and a proven Quality by Design approach.
If the API you need is not listed with our prequalified network, we can find it. Contact us to learn more about how LGM Pharma takes the complexity out of API Sourcing.
LGM PHARMA
Call Toll-Free: 1-800-881-8210
Corporate Headquarters:
6400 Congress Avenue, Suite 1400
Boca Raton, FL 33487, USA
