LGM Pharma

LGM Pharma provides comprehensive Contract Development and Manufacturing Organisation (CDMO) services, API sourcing, and analytical testing services.

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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.

Certification
United States FDA, Canada Health Canada

Capabilities

Contact Information

Website
Address
6400 Congress Ave, 500, Boca Raton, FL, 33487, US
Zip/Post Code
33487

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