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:

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.

LGM Pharma Acquires CDMO

On July 27, 2020, LGM Pharma announced its acquisition of the formulation development and drug product contract manufacturing business of Nexgen Pharma, Inc. As a result, you will notice our new logo and visuals throughout the website. We’re working on updates to reflect the exciting, expanded CDMO capabilities and services we now can offer you.

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