Business Details
Your Partner for API Sourcing and CDMO Solutions
LGM Pharma is a global leader in pharmaceutical outsourcing solutions with nearly a century of combined experience across our integrated teams. Our company was formed through the strategic merger of LGM Pharma and Nexgen Pharma's drug product division, combining expertise in API sourcing with comprehensive CDMO capabilities. We maintain a vast network of over 300 prequalified cGMP manufacturers worldwide while operating US-based facilities totaling more than 100,000 square feet of advanced manufacturing space. Our embedded regulatory specialists work alongside R&D teams from project inception to ensure compliance with FDA requirements throughout the development lifecycle.With dedicated divisions for supply chain management and drug manufacturing, we provide end-to-end support for pharmaceutical and biotech clients seeking quality-driven solutions. Our commitment to quality-by-design principles is demonstrated through rigorous method validation, stability testing, and analytical services performed by specialized teams in California, Colorado, and Texas. We serve clients globally from strategic locations in the United States, Israel, and Europe while maintaining direct control over API sourcing logistics and regulatory submissions.
Services
API Sourcing
CDMO Services
Formulation Development
Analytical Testing
Stability Services
Regulatory Support
Strategic Sourcing
505(b)(2) Pathway
Logistics Management
Manufacturer Qualification
Highlights and features
- We maintain over 100,000 sq ft of US-based cGMP manufacturing facilities
- Our team has nearly 100 years of combined pharmaceutical industry experience
- We operate a global network of prequalified cGMP API manufacturers
- Regulatory specialists are embedded within R&D teams for streamlined approvals
- We provide end-to-end support from API sourcing through regulatory submission
Services
API Sourcing
We specialize in sourcing complex active pharmaceutical ingredients globally. Our team leverages relationships with over 300 cGMP manufacturers to secure niche APIs and manage import logistics. We provide quality assurance through on-site audits and supply chain risk mitigation strategies for pharmaceutical companies.
CDMO Services
Our full-service CDMO offers development and manufacturing for multiple dosage forms. We support projects from concept through commercialization with DEA-licensed facilities in the United States. Services include formulation development, analytical testing, and regulatory submission support for FDA approval.
Analytical Testing
We provide comprehensive analytical services using advanced instrumentation including ICP-MS and HPLC. Our three US laboratories perform method validation, microbiological testing, and quality control for APIs and finished drug products to ensure regulatory compliance.
Stability Services
Our stability testing services use validated environmental chambers to generate ICH-compliant data. We support stability studies for clinical batches and commercial products with customized protocols to meet regulatory requirements for drug approval.
Regulatory Support
Our embedded regulatory team provides end-to-end support for NDA, ANDA, and 505(b)(2) submissions. We integrate regulatory strategy with R&D activities to streamline FDA approval processes for pharmaceutical products.
Questions
What pharmaceutical services does LGM Pharma offer?
We provide API sourcing, CDMO services, formulation development, analytical testing, stability studies, and regulatory support for drug products.
Do you support 505(b)(2) drug development projects?
Yes, our team offers specialized support for 505(b)(2) pathway projects with embedded regulatory expertise.
Where are your manufacturing facilities located?
We operate US-based facilities in Colorado, California, and Texas with additional locations in Kentucky and Israel.
How do you ensure API quality?
We maintain a global network of prequalified cGMP manufacturers and conduct regular on-site quality audits.
What analytical services do you provide?
Our services include method validation, stability testing, and microbiological analysis using state-of-the-art equipment.
Can you help with international API sourcing?
Yes, our Israel-based team manages global API sourcing with logistics support for international imports.
