Contract Development & Manufacturing
Organization (CDMO) Services

• Specialize in solid, semi-solids and oral liquid dosage forms

• Services include formulation, analytical method development and stability studies

• US based facilities with FDA approval and GMP compliance

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API Sourcing & Procurement

• Access to a portfolio of over 2,000 APIs from every therapeutic category

• Robust network of 400+ reliable API manufacturers with a tradition of regulatory excellence

• Support programs as a primary or alternate source, from R&D through commercialization

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Supply Chain Management

• Consultative approach to understand the unique needs of your project and the
timeline for development or commercialization

• Global regulatory expertise ensuring a smooth journey from concept to regulatory
approval in the USA, EU and other highly regulated markets

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505(b)(2) Support

• Supporting 120+ drug development programs pursuing the 505(b)(2) regulatory pathway,
in a variety of therapeutic categories and at every life-cycle stage (pre-clinical to commercial)

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Who We Are

LGM Pharma is a leading USA based contract development and manufacturing organization (CDMO) and provider of active pharmaceutical ingredients (APIs). With excellent API sourcing and supply chain expertise together with our drug product contract development and manufacturing solutions, LGM is a premier end-to-end solutions provider to the global pharmaceutical industry. We get your products to market faster by delivering customized solutions, securing and optimizing your supply chain with our extensive qualified API partner network, drug product development and manufacturing facilities, and regulatory and market intelligence services. Full-service, expert support that accelerates the new product pathway. Now that’s smart!

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).