LGM Pharma Invests $6 Million to Expand U.S. Drug Manufacturing Capabilities
LGM Pharma, a leading provider of tailored active pharmaceutical ingredient (API) and contract development and manufacturing organization (CDMO) services, has announced a significant investment of over $6 million to expand its manufacturing facility in Rosenberg, Texas. This investment represents the first phase of LGM Pharma’s CDMO growth strategy and will enhance the company’s capacity to manufacture liquid, suspension, semi-solid, and suppository drug products. The expansion aligns with the growing demand for high-quality, U.S.-based pharmaceutical manufacturing solutions and reflects LGM Pharma’s commitment to meeting regulatory standards while maintaining uninterrupted operations.
Enhancing Domestic Manufacturing Capabilities
The pharmaceutical industry is experiencing an increasing demand for reliable domestic drug production, particularly in light of supply chain disruptions and global uncertainties. LGM Pharma’s expansion of its Rosenberg facility comes at a critical time, ensuring that pharmaceutical companies have access to high-quality, cGMP-compliant manufacturing solutions in the United States.
As part of the expansion, the Rosenberg facility will significantly enhance its infrastructure and quality systems to support increased production volumes. The site will remain fully operational throughout the expansion process, ensuring that customers experience no disruptions in their ongoing projects.
“Our investment in this expansion is a strategic step toward strengthening the U.S. pharmaceutical manufacturing landscape,” said Prasad Raje, Ph.D., CEO of LGM Pharma. “We are focused on providing our customers with the highest levels of quality and reliability. With several prescription drug projects in development, including 505(b)(2) and ANDA submissions, this investment ensures that we can continue supporting our customers as they bring innovative and essential products to market.”
Meeting the Growing Market Demand for CDMO Services
The contract development and manufacturing market for liquid, suspension, semi-solid, and suppository drugs is projected to witness significant growth over the next decade. North American manufacturers, including LGM Pharma, will play a crucial role in addressing market demand and supporting drug developers in bringing their products to commercialization.
The U.S. and Canadian market for suppository drugs alone is anticipated to reach $1.3 billion by 2035, reflecting an increasing acceptance of this dosage form. Additionally, semi-solid and liquid formulations continue to see rising demand due to their advantages in patient compliance, ease of administration, and targeted drug delivery applications. LGM Pharma’s investment is designed to support these industry trends and offer pharmaceutical companies a robust, reliable, and regulatory-compliant manufacturing solution.
By expanding its capabilities in Rosenberg, LGM Pharma is ensuring that its manufacturing infrastructure is positioned to meet the evolving needs of pharmaceutical companies engaged in both brand-name and generic drug development.
Strategic Expansion to Support Prescription Drug Development
LGM Pharma has a strong track record in supporting prescription drug projects through various regulatory pathways, including the 505(b)(2) and Abbreviated New Drug Application (ANDA) programs. The company currently manufactures prescription drug products at its oral solid dose facility in Irvine, California, and is now positioning the Rosenberg facility to match those same high standards for liquid, suspension, semi-solid, and suppository products.
Hamilton Lenox, Chief Commercial Officer of LGM Pharma, emphasized the importance of the Rosenberg expansion: “With our current prescription product manufacturing capabilities in Irvine, this expansion ensures that our Rosenberg site will offer the same level of expertise, quality assurance, and regulatory compliance. Our customers rely on us for high-quality U.S.-based CDMO services, and this investment further solidifies our commitment to delivering excellence in pharmaceutical manufacturing.”
Strengthening Regulatory Compliance and Quality Systems
The pharmaceutical manufacturing landscape is highly regulated, requiring companies to adhere to strict compliance and quality control standards. LGM Pharma’s investment in the Rosenberg facility includes infrastructure enhancements designed to support compliance with FDA regulations, current good manufacturing practices (cGMP), and other stringent quality requirements.
The expansion will also introduce track-and-trace serialization capabilities at the Rosenberg site. This critical enhancement aligns with evolving regulatory requirements and helps ensure product traceability, minimizing the risk of counterfeit drugs entering the supply chain. Serialization also supports compliance with the Drug Supply Chain Security Act (DSCSA), which mandates increased transparency and security within the pharmaceutical supply chain.
“We recognize the importance of ensuring that every product manufactured at our facility meets the highest regulatory and safety standards,” said Raje. “By incorporating serialization and advanced quality control measures, we are not only expanding our production capacity but also strengthening our ability to deliver compliant and secure pharmaceutical products.”
Addressing Supply Chain Challenges with U.S.-Based Manufacturing
The pharmaceutical industry has faced significant supply chain challenges in recent years, exacerbated by factors such as global trade uncertainties, tariffs, and pandemic-related disruptions. Many pharmaceutical companies are now seeking reliable domestic manufacturing solutions to mitigate these risks and ensure consistent drug supply.
LGM Pharma’s investment in its Rosenberg facility directly addresses these concerns by providing a robust, U.S.-based CDMO option for pharmaceutical companies looking to reduce dependence on international supply chains. By expanding its domestic capabilities, LGM Pharma is not only supporting its customers but also contributing to the broader effort to strengthen pharmaceutical manufacturing resilience in the United States.
“The need for domestic pharmaceutical manufacturing has never been more apparent,” said Lenox. “We are committed to offering our customers a stable, high-quality manufacturing partner in the U.S., ensuring they have access to reliable production for their prescription drug products.”
Opportunities for Pharmaceutical Companies
LGM Pharma’s expanded manufacturing capabilities present significant opportunities for pharmaceutical companies developing 505(b)(2), NDA, ANDA, branded, and generic prescription drug products. The company’s expertise in formulation development, regulatory compliance, and commercial manufacturing makes it a trusted partner for drug developers looking to bring their products to market efficiently and successfully.
To further engage with industry stakeholders, LGM Pharma executives will be available to discuss their expanded manufacturing capabilities at DCAT Week, taking place from March 17-20, 2025, in New York City. Companies interested in exploring LGM Pharma’s services can also visit LGMPharma.com for more information.
