LGM Pharma has announced plans to expand its manufacturing facility in Rosenberg, Texas. The company, which provides tailored API and CDMO services for the full drug product lifecycle, is investing over $6 million to increase its capacity for liquid, suspension, semi-solid, and suppository drug products. This expansion is part of the company’s Phase I CDMO growth strategy and will enhance its ability to meet rising demand for reliable U.S.-based production.
The expanded facility will support the growing number of prescription drug projects, including 505(b)(2) and Abbreviated New Drug Application (ANDA) programs. The Rosenberg site will remain operational throughout the expansion, continuing to meet FDA regulations and current good manufacturing practices (cGMP). The investment will also incorporate track and trace serialization capabilities to align with regulatory requirements and improve product traceability.
What people are saying
In a recent quote, Prasad Raje, Ph.D., CEO of LGM Pharma, said, “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.”
Hamilton Lenox, Chief Commercial Officer of LGM Pharma, added, “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.”
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