APIs are critical components in medication, responsible for their therapeutic effects. This exploration delves into various types of APIs like small molecules, biologics, and specialty drugs, emphasizing their essential role in pharmaceutical formulation and manufacturing. Discover the innovative strategies behind API production at LGM Pharma, a key player ensuring quality and compliance in the pharmaceutical industry

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.

When you’re partnering with an API sourcing expert here in the US, they can easily help secure your 505 b 2 pathway project supply chain through various strategies and processes. It involves prequalifying manufacturers, offering prescription drug market intelligence, finding niche molecules, matching your drug manufacturing requirement with the best API manufacturer, complying with global regulatory requirements, etc.