- LGM Pharma is investing over $6 million to expand its Rosenberg, Texas, manufacturing facility as part of its Phase I CDMO growth strategy.
- The expansion will increase production capacity for liquid, suspension, semi-solid, and suppository drug products while maintaining FDA and cGMP compliance.
LGM Pharma has announced a $6 million investment to expand its Rosenberg, Texas, manufacturing facility, strengthening its position as a U.S.-based contract development and manufacturing organisation (CDMO). The expansion will enhance production capacity for liquid, suspension, semi-solid, and suppository drug products, supporting increased demand for domestic pharmaceutical manufacturing.
The expansion comes as the company experiences continued growth in prescription drug projects, including 505(b)(2) and Abbreviated New Drug Application (ANDA) programs. The enhancements to the Rosenberg facility will allow for greater production volumes while ensuring compliance with U.S. Food and Drug Administration (FDA) regulations and current good manufacturing practices (cGMP). Operations at the site will continue uninterrupted during the expansion.
Prasad Raje, Ph.D., CEO of LGM Pharma, stated, “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.”
The investment is aimed at strengthening both infrastructure and quality systems at the Rosenberg facility. LGM Pharma also manufactures prescription drug products at its Irvine, California, facility, which focuses on oral solid dose forms. The expansion will bring the Rosenberg site to the same high standards, allowing it to support a wider range of prescription drug formulations.
In addition to boosting capacity, the Rosenberg facility will incorporate track and trace serialization capabilities, aligning with regulatory requirements to enhance product traceability and compliance. As supply chain disruptions and global uncertainties continue to impact pharmaceutical manufacturing, LGM Pharma’s investment reinforces its commitment to providing reliable, U.S.-based contract manufacturing solutions.