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.
