LGM Pharma Expands U.S. Drug Manufacturing with $6M Investment
LGM Pharma, a leading provider of tailored active pharmaceutical ingredient (API) and contract development and manufacturing organization (CDMO) services for the full drug product lifecycle, has announced a strategic investment exceeding $6 million to enhance its manufacturing facility in Rosenberg, Texas. This expansion is part of LGM Pharma’s Phase I CDMO growth strategy, aimed at increasing capacity for liquid, suspension, semi-solid, and suppository drug products to meet the growing demand for reliable U.S.-based pharmaceutical production.
Meeting the Growing Demand for Domestic Drug Manufacturing
With the pharmaceutical industry experiencing a shift towards domestic manufacturing due to supply chain disruptions and regulatory concerns, LGM Pharma’s investment underscores its commitment to strengthening U.S.-based production. The company has witnessed sustained growth in prescription drug projects, particularly in 505(b)(2) and Abbreviated New Drug Application (ANDA) programs.
By expanding the Rosenberg facility, LGM Pharma aims to enhance its ability to support clients developing prescription drug products while ensuring compliance with FDA regulations and current good manufacturing practices (cGMP). Notably, the facility will remain fully operational throughout the expansion process, minimizing disruptions to ongoing production and ensuring a seamless transition as capacity increases.
According to Dr. Prasad Raje, CEO of LGM Pharma, “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.”
Expanding Capacity to Address Market Trends
The contract development and manufacturing market for liquid, suspension, semi-solid, and suppository drugs is expected to grow significantly over the next decade. North America, particularly the U.S. and Canada, plays a crucial role in this expansion. Market research indicates that the U.S. and Canada suppositories market alone is projected to reach $1.3 billion by 2035, reflecting a growing acceptance of this dosage form among consumers and healthcare providers.
Recognizing this upward trend, LGM Pharma’s investment will not only expand its infrastructure but also strengthen its quality systems. This enhancement will allow the company to manufacture prescription drug products—including topical formulations and suppositories—while maintaining the highest regulatory and quality assurance standards.
Hamilton Lenox, Chief Commercial Officer of LGM Pharma, emphasized the importance of the expansion, stating, “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.”
Strengthening Supply Chain Resilience
LGM Pharma’s expansion is a direct response to the growing need for resilient domestic supply chains in the pharmaceutical sector. In recent years, global uncertainties, tariffs, and supply chain disruptions have exposed vulnerabilities in pharmaceutical manufacturing, prompting regulatory agencies and industry leaders to advocate for increased U.S.-based production.
As part of its investment, LGM Pharma is also integrating track and trace serialization capabilities at the Rosenberg facility. This enhancement aligns with evolving regulatory requirements to improve product traceability, ensure compliance, and safeguard against counterfeit drugs.
By prioritizing advanced manufacturing technologies and stringent regulatory adherence, LGM Pharma is positioning itself as a reliable CDMO partner for pharmaceutical companies seeking high-quality, U.S.-based production solutions.
Supporting a Broad Range of Drug Development Needs
LGM Pharma’s expansion benefits pharmaceutical companies developing 505(b)(2), New Drug Application (NDA), ANDA, branded, or generic prescription drug products. The company’s increased capacity will enable it to support a wider range of development and manufacturing needs, from early-stage formulation to commercial-scale production.
Additionally, the investment aligns with broader industry goals to enhance drug availability and affordability. By bolstering domestic manufacturing capabilities, LGM Pharma is contributing to a more sustainable pharmaceutical supply chain, reducing reliance on international suppliers, and improving patient access to essential medications.
Industry Engagement and Future Outlook
LGM Pharma’s executives will be actively engaging with industry leaders at key pharmaceutical events, including DCAT Week in New York City from March 17-20, 2025. This event provides an opportunity for pharmaceutical companies to learn more about LGM Pharma’s expanded manufacturing capabilities and explore potential collaborations.
The company encourages industry stakeholders, regulatory agencies, and potential partners to visit LGMPharma.com to learn more about its services, expansion plans, and commitment to quality-driven pharmaceutical manufacturing.
LGM Pharma’s $6 million investment in its Rosenberg, Texas facility marks a significant milestone in strengthening U.S.-based drug manufacturing. As demand for high-quality, domestic pharmaceutical production grows, this expansion will enhance the company’s ability to support prescription drug projects while maintaining the highest standards of regulatory compliance and manufacturing excellence.
With a strategic focus on innovation, quality, and supply chain resilience, LGM Pharma is well-positioned to play a pivotal role in the evolving pharmaceutical landscape, ensuring that patients and healthcare providers have access to safe, effective, and reliable medications.
