
Description
LGM Pharma is a leading contract development and manufacturing organisation (CDMO) specialising in active pharmaceutical ingredient (API) sourcing and comprehensive drug product services for the pharmaceutical, biotechnology, and compounding pharmacy sectors.
With a legacy spanning nearly a century, LGM Pharma has evolved from a prominent API sourcing entity into a full-service CDMO. The company's extensive global network of over 300 prequalified GMP-compliant API manufacturers ensures access to high-quality APIs, optimising supply chain management and mitigating risks. LGM Pharma's U.S.-based facilities encompass more than 100,000 square feet dedicated to GMP research and development, pilot plant operations, and cGMP manufacturing, supporting projects from early R&D through to commercialisation.
Key Products and Services
API Sourcing: Leveraging strong relationships with world-class manufacturers globally, LGM Pharma reduces supply chain risks and improves access to high-quality APIs.
CDMO Services:
Formulation Development: Expertise in developing solid dose, liquid, semi-solid, and suppository formulations.
Manufacturing: Capabilities include production of solid dose delivery systems, liquids/suspensions, semi-solids, and suppositories, with facilities equipped for commercial scale-up.
Regulatory Management: In-house experts provide tailored regulatory strategies, assisting with CMC requirements and supporting ANDA and NDA submissions.
Analytical Services:
Analytical Testing: Comprehensive method development and validation services.
Stability Services: Robust stability studies to ensure product integrity throughout its lifecycle.
LGM Pharma's commitment to quality, innovation, and customer-centric solutions positions it as a trusted partner in the pharmaceutical industry. By integrating API sourcing with end-to-end CDMO services, the company accelerates the path to market for clients, ensuring efficiency and compliance at every stage of the drug development process.
Capabilities
- Accelerated Stability Studies
- Analytical Services
- Assay Development
- Capsule
- Chemistry (CMC)
- Chromatography
- Clinical Dose
- Clinical Packaging
- Clinical Trial Materials
- Clinical Trials
- Contract Development
- Contract Development and Manufacturing (CDMO)
- Contract Packaging
- Controlled Release
- Controlled Substances
- Creams & Ointments
- Custom Manufacturing
- Dissolution Testing
- Dosage Form Development
- Dose Form
- Drug Development
- Filling
- Fine Chemicals
- Forced Degradation Studies
- Formulation Development
- Gels
- Generics
- Glass
- Granulation
- ICH
- ICP
- IND/NDA Submissions
- Labelling
- Liquids
- Lotion Pumps
- Microbiological Testing
- Mixing & Blending
- Mixing and Granulating Equipment
- Nasal Delivery
- Non Sterile Dosage
- Nutraceuticals
- Oral Drug Delivery
- OTC
- Packaging
- Particle Size Analysis
- Photostability
- Physical Testing
- Plastic Bottles and Jars
- Powders
- Preclinical Testing
- Preformulation
- Process Characterization
- Process Development
- Process Validation Studies
- Project Management
- Quality QA/QC
- Raw Materials Analysis
- Regulatory Services
- Research & Development
- Semisolids
- Serialization
- Shipping
- Solid Dosage
- Solutions & Suspensions
- Sourcing
- Stability Studies
- Supply Chain Management
- Suppositories
- Sustained Release
- Sustained Release Delivery Systems
- Tablet Coating
- Tablet Press
- Tablets
- Technology Transfer
- Topicals
- Trace Metal Analysis
- Tubes
- Validation
Contact Information
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