505(b)(2) Pathway

Secure the API Supply for Your 505(b)(2) Application 

Trust your 505(b)(2) pathway to LGM’s API sourcing experts

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. 

LGM Pharma secures your 505(b)(2) pathway project supply chain by:

  • Pre-qualifying manufacturers to ensure high-quality cGMP API with a US drug master file (DMF)
  • Providing purchasing power and negotiating on your behalf
  • Offering market intelligence with visibility into market landscape, patents, pricing, and export and shipment trend data
  • Finding niche molecules including from manufacturers that can do custom synthesis
  • Matching you with the best manufacturer for your project that can scale with your needs
  • Acting as your advocate with the manufacturer on timelines, costs, changing market conditions, or on any issues that may arise
  • Navigating global regulatory requirements for your 505(b)(2) application
  • Mitigating geopolitical security risk by offering secondary qualified suppliers in a different geographic region
  • Ensuring quality through the entire chain of custody, from supplier to your doorstep
  • Conducting due diligence and ongoing monitoring of manufacturer compliance
  • Providing specialized logistics expertise with a team strategically located in Israel to manage the flow of API from Asia and Europe to the US

Drug Development and Manufacturing

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.

LGM Pharma has years of experience sourcing APIs and supporting the 505(b)(2) pathway. Are you searching for a particular API?

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 supports 505(b)(2) pathway programs across the drug development lifecycle and dosage forms.

Programs by stage of development:

Clinical trials

Programs by stage of dosage form:


LGM Pharma supports 100+ drug development programs pursuing the 505(b)(2) pathway, in just about every therapeutic category and at every stage – R&D/pre-clinical to commercial