LGM Pharma
6400 Congress Avenue, Suite 1400
Boca Raton, FL 33487
T: (800) 881-8210
W: https://lgmpharma.com/

Company Description

LGM Pharma is a leading contract development and manufacturing organization (CDMO) offering a robust suite of capabilities, including comprehensive Active Pharmaceutical Ingredient (API) sourcing, analytical testing services, and drug product CDMO solutions to the pharmaceutical, biotechnology, and compounding pharmacy industries. LGM Pharma assists clients in managing all phases of the drug product development process, from API sourcing through to commercialization. LGM Pharma’s extensive global network of qualified API partners enables clients to optimize supply chain management and distribution. Services include API sourcing and procurement, formulation development, analytical method development, method and process validation, ANDA / NDA submission, stability studies, and raw material and finished product testing and packaging. LGM Pharma is committed to quality and has a long-established positive regulatory track record, providing expert regulatory and market intelligence services to its clients. The company is focused on customer service and customized solutions, providing clients a comprehensive one-stop manufacturing solution that reduces risk, increases efficiency, and accelerates the path to commercialization.

Company Background

In July 2020, LGM Pharma acquired the formulation development and drug product contract manufacturing business of Nexgen Pharma, Inc. The combination merged LGM’s global leadership in API sourcing, distribution, and supply chain management with Nexgen Pharma’s comprehensive drug product CDMO services. The combined firm continues to be known as LGM Pharma and has all the capabilities needed to help pharma and biotech clients accelerate and optimize the new product pathway, from R&D and clinical development through regulatory submission commercial manufacturing. LGM added standalone analytical testing services as an offering in 2023. The combined firm continues to be known as LGM Pharma and has all the capabilities needed to help pharma and biotech clients accelerate and optimize the new product pathway, from R&D, clinical trial materials and analytical testing through regulatory submission and commercial manufacturing.

Service Offerings

• API Sourcing
• Standalone analytical testing services, including rapid sterility testing.
• Formulation Development
• Oral Solid Dose (OSD) development and commercial manufacturing
• Liquids and Suspensions
• Semi-Solids
• Suppositories
• Commercial Scale-Up and manufacturing
• Regulatory Management
• Stability Services
• FDA registered and cGMP compliant

Whitepapers 

Formulating and Manufacturing Suppositories: A Guide for Niche Drug Developers

Outsourcing Analytical Testing: Three Problems to Avoid

Finding the Right CDMO for Your Niche Drug Project

Five “Must Ask” Questions to Find the Right CDMO

Five Reasons to Outsource API Procurement