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.