LGM Pharma Expands U.S. Drug Manufacturing with $6M Investment in Advanced Dosage Capabilities
LGM Pharma, a leading provider of tailored API and CDMO services across the entire drug product lifecycle, has announced a significant investment of over $6 million to enhance its manufacturing capabilities in Rosenberg, Texas. This expansion is a crucial part of the company’s Phase I CDMO growth strategy, aimed at increasing production capacity for liquid, suspension, semi-solid, and suppository drug products. The move addresses the growing demand for high-quality, U.S.-based pharmaceutical manufacturing amid shifting industry dynamics and regulatory expectations.
Strengthening U.S. Drug Manufacturing Infrastructure
The pharmaceutical industry is undergoing a transformation, with increasing emphasis on local manufacturing due to supply chain disruptions, regulatory changes, and a push for greater domestic production. LGM Pharma’s strategic investment in its Rosenberg facility is a direct response to these challenges. By expanding its capabilities, the company aims to provide a more reliable and efficient manufacturing solution for pharmaceutical developers looking to bring innovative and essential therapies to market.
The enhancements to the Rosenberg site will accommodate higher production volumes while ensuring compliance with stringent FDA regulations and current good manufacturing practices (cGMP). Importantly, the facility will remain fully operational throughout the expansion, minimizing disruptions to ongoing projects.
Prasad Raje, Ph.D., CEO of LGM Pharma, emphasized the company’s commitment to advancing U.S. pharmaceutical manufacturing. “LGM Pharma is making strategic investments to support the growing need for high-quality domestic drug production,” he said. “We have multiple prescription products in development, including 505(b)(2) and Abbreviated New Drug Application (ANDA) programs, with one ANDA already submitted to the FDA. This expansion ensures we continue to deliver quality, reliability, and confidence to our partners as they bring new therapies to market.”
Expanding Capacity to Meet Growing Market Needs
The contract development and manufacturing (CDMO) market for liquid, suspension, semi-solid, and suppository drug products is experiencing robust growth. Industry analysts project significant expansion in demand for these dosage forms over the next decade, with North American manufacturers playing a key role in meeting this need.
A recent market report indicates that the U.S. and Canadian suppositories market is expected to reach $1.3 billion by 2035, reflecting increased acceptance and use of this delivery method. This trend underscores the importance of LGM Pharma’s expansion efforts, which will enable the company to better serve pharmaceutical companies developing prescription drug products in these categories.
Enhancing Quality Systems and Regulatory Compliance
As part of the $6 million investment, LGM Pharma is not only increasing production capacity but also strengthening its infrastructure and quality control systems at the Rosenberg site. This includes the implementation of advanced quality assurance measures to ensure consistency, efficacy, and safety across all manufactured drug products.
Hamilton Lenox, Chief Commercial Officer of LGM Pharma, highlighted the importance of maintaining the highest industry standards. “We currently manufacture prescription products at our oral solid dose facility in Irvine, California. The Rosenberg expansion will bring this site to the same high level of operational excellence, 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.”
Addressing Supply Chain Challenges with Domestic Manufacturing
The global pharmaceutical industry has faced significant supply chain disruptions in recent years due to geopolitical tensions, tariffs, and pandemic-related challenges. These disruptions have accelerated the need for dependable, U.S.-based manufacturing solutions. LGM Pharma’s investment provides a robust domestic alternative for pharmaceutical companies seeking to mitigate risks associated with overseas production.
Additionally, the Rosenberg expansion includes the integration of advanced track-and-trace serialization capabilities, ensuring compliance with evolving regulatory requirements. These enhancements will improve product traceability, reduce the risk of counterfeiting, and reinforce patient safety measures.
Opportunities for Pharmaceutical Developers
LGM Pharma’s expanded capabilities will support a wide range of pharmaceutical developers, including those working on 505(b)(2), NDA, ANDA, branded, and generic prescription drug products. Companies seeking reliable and scalable manufacturing solutions are encouraged to explore collaboration opportunities with LGM Pharma.
For those interested in learning more, LGM Pharma executives will be available for discussions at DCAT Week, taking place from March 17-20, 2025, in New York City. Additional information can also be found at LGMPharma.com.
