LGM Pharma, a leading provider of tailored API and CDMO services for the entire drug product lifecycle, announced an investment of over $6 million to expand its Rosenberg, Texas, manufacturing facility as part of its Phase I CDMO growth strategy. The expansion will increase capacity for liquid, suspension, semi-solid, and suppository drug products, addressing the rising demand for reliable U.S.-based production.
This investment comes as LGM Pharma experiences sustained growth in prescription drug projects, such as 505(b)(2) and Abbreviated New Drug Application (ANDA) programs. And the Rosenberg facility enhancements will accommodate increased production volumes while ensuring compliance with FDA regulations and current good manufacturing practices (cGMP). The site will remain fully operational throughout the expansion.
The contract development and manufacturing market for liquid, suspension, semi-solid, and suppository drugs is expected to grow significantly over the next decade, with North American manufacturers playing a key role.
LGM Pharma’s investment will strengthen infrastructure and quality systems at the Rosenberg facility, enhancing its ability to manufacture prescription drug products, including topical and suppository products, while maintaining the highest regulatory and quality standards.
With supply chain disruptions, tariffs, and global uncertainties continuing to impact pharmaceutical manufacturing, LGM Pharma’s investment provides a dependable domestic solution. The expansion also includes track-and-trace serialization capabilities at the Rosenberg facility, aligning with regulatory requirements to enhance product traceability and ensure compliance.
KEY QUOTES:
“LGM Pharma is making strategic investments to support the growing need for high-quality domestic drug manufacturing. We have several prescription products in development, including both 505(b)(2) and ANDA projects, with one ANDA already submitted to the FDA. This expansion ensures we can continue providing our customers with the quality, reliability, and confidence they need to bring these products to market.”
- Prasad Raje, Ph.D., CEO of LGM Pharma
“We currently manufacture prescription products at our oral solid dose facility in Irvine, California. The Rosenberg expansion will elevate this site to the same high standards, allowing us to support customers developing liquid, suspension, semi-solid, and suppository prescription drug products with the same level of expertise and quality assurance from a U.S.-based manufacturing site.”
- Hamilton Lenox, Chief Commercial Officer of LGM Pharma
