Accelerating the New Product Pathway from Early Development to Commercialization
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!
LGM Pharma streamlines API procurement and supply chain efforts for the Bio/Pharma, Generic and OTC industries.
We offer a customized approach with global reach and long-term collaboration that shortens time from sourcing to distribution of APIs:
Access to a robust global network of CGMP compliant and EU & US-FDA inspected suppliers, that offer a diverse portfolio of APIs
Quick access to full technical assistance & complete regulatory support
Support programs as either a primary or alternate source, both on an R&D or commercial scale
Handling of all shipping, distribution and importing of the API (from the supplier to your facility)
Develop and Manufacture with LGM
With 100,000-square-feet of fully equipped facilities in California, Colorado, and Texas, LGM Pharma is ready to formulate, develop, and manufacture drug products in the following formulations:
- Solid dose
- Non-Sterile Liquids
- Sustained release
We offer comprehensive one-stop services that include:
- Robust API-procurement strategies
- Formulation development, analytical method development / validation, process validation
- ANDA / NDA regulatory support and submission
- CMC assistance
- Stability studies
- Raw material and finished product testing
- Packaging and distribution
Quality is a cornerstone of LGM Pharma. Our drug product manufacturing and quality processes follow the highest standards – meeting all current Good Manufacturing Practices (CGMP) established by the FDA.
We use a quality by design approach to product development to maintain control over cost, quality, and speed of the drug manufacturing process.
We’re proud of our regulatory track record, with no Form 483 observations from FDA our recent inspections of our development and manufacturing facilities. Our clients have seen generic drug products achieve FDA approval for close to 20 years in the Hatch/Waxman era.
Full-service, expert support that accelerates the new product pathway. Now that’s smart.