We are driven by Innovation

Who We Are

LGM Pharma is an innovation-driven API and procurement specialist, involved in the distribution of quality cGMP pharma ingredients to leading pharmaceutical companies. We specialize in providing full sourcing options, complete technical capabilities and regulatory support for our products.

A Consultative Approach

Based on the scale and scope of development projects with which we are involved, LGM Pharma is able to provide our customers with a seasoned perspective and valuable insight.

Aggregated Mindshare &
Experience

Aggregated Mindshare & ExperienceWhether it is an ANDA, NDA or a 505(b)2 project, LGM has already supported hundreds of similar projects and has aggregated the mindshare and experience that has been an invaluable resource to our clients.

Cost Effective APIs & Large Development Quantities

Cost Effective APIs & Large Development Quantities Based on your specific requirements, we can provide cost effective APIs for initial research and larger development quantities towards product commercialization

Fully Accredited & Approved Manufacturing Sites

Fully Accredited & Approved Manufacturing SitesAll of our cGMP APIs originate from fully approved manufacturing sites. LGM Pharma is able to provide technical packages, letters of access (LoA) to filed DMFs and complete assistance towards any regulatory filings.

The 505(b)(2) Pathway

An Effective Option for Some Drug Candidates

Situated between the NDA and the ANDA is an increasingly popular drug commercialization pathway – the 505(b)(2) – and it potentially offers pharmaceutical companies clear advantages. The 505(b)(2) pathway’s popularity can be attributed to the benefits an ANDA and full NDA could offer – namely, a shorter, less expensive, lower risk process which still confers a period of market exclusivity.

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).