Our 505(b)(2) Expertise

At present, LGM Pharma supports 120+ drug development programs pursuing the 505(b)(2) pathway, in just about every therapeutic category and at every stage (pre-clinical to commercial).

Programs by stage of development:
R&D
52%
Pre-Clinical  
22%
Clinical   Trials  
23%
Commercial  
3%
Programs by stage of dosage form:
Implant  
12%
Inhalation  
7%
Injectable  
19%
Ophthalmic  
12%
Oral  
19%
Sublingual  
8%
Topical  
6%
Transdermal  
17%

LGM can help ensure your project is successful by providing:

  • Access to a portfolio of over 2,000 APIs from every therapeutic category to support any stage of development, from early feasibility to commercial production.
  • A consultative approach to understand your unique needs.
  • Market insight and industry knowledge to ensure the API for your project meets the required specifications for your unique delivery system.
  • Custom synthesis / API modifications via LGM’s 150+ qualified API manufacturers globally that comply with CGMP guidelines and are FDA inspected.
  • Support programs as a primary source, from R&D through commercialization.
  • Risk mitigation strategies for your supply chain by providing secondary or tertiary sources from different geographical regions.
  • Quality & regulatory documentation / support required for regulatory submissions in the USA, EU and other highly regulated markets.
  • Sourcing and supply chain expertise, handling all aspects of global logistics, customs / FDA clearance, in order to deliver the API to your door.
  • Introductions to CDMO’s specializing in formulation development and commercial manufacturing of Finished Dosage Form products.

Working on a project using the 505(b)(2) pathway?

We’ve been working with clients for years on 505(b)(2) programs. At present, we are supporting over 120 API programs utilizing the 505(b)(2) pathway.

This website uses cookies. By using our site, you agree to our terms of service