LGM Pharma Invests Over $6M to Expand U.S. Manufacturing Facility in Texas
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 of more than $6 million to expand its Rosenberg, Texas manufacturing facility. This move is part of the company’s Phase I CDMO growth strategy, aimed at increasing its capacity to produce liquid, suspension, semi-solid, and suppository drug products. The expansion will address the rising demand for reliable U.S.-based drug manufacturing and support LGM Pharma’s growth in the prescription drug market.
A Strategic Move to Meet Growing Demand
The pharmaceutical industry continues to see increasing demand for domestic manufacturing solutions, particularly in the production of prescription drug products. This $6 million investment in the Rosenberg facility is designed to support that demand and enable LGM Pharma to meet the needs of a rapidly growing market. The expansion will allow the company to scale up production volumes of various drug formats, including liquids, suspensions, semi-solids, and suppositories, while ensuring compliance with FDA regulations and current Good Manufacturing Practices (cGMP).
LGM Pharma’s growth is fueled by its work with prescription drug programs, particularly the 505(b)(2) and Abbreviated New Drug Application (ANDA) pathways. The company is currently developing several prescription drug products, including one ANDA that has already been submitted to the FDA. As part of its Phase I expansion, LGM Pharma is focused on increasing the production capacity of its Rosenberg site while continuing to operate in full compliance with regulatory standards.
Enhancing Manufacturing Capabilities at Rosenberg Facility
Prasad Raje, Ph.D., CEO of LGM Pharma, highlighted the strategic nature of the investment, saying, “LGM Pharma is making strategic investments to support the growing need for high-quality domestic drug manufacturing. With several prescription products in development, including both 505(b)(2) and ANDA projects, this expansion ensures we can continue providing our customers with the quality, reliability, and confidence they need to bring these products to market.”
This expansion not only aims to increase production capacity but also strengthens the infrastructure and quality systems at the Rosenberg facility. The company plans to enhance its ability to manufacture prescription drug products while maintaining the highest standards of regulatory compliance and quality assurance. With these upgrades, LGM Pharma will be able to support a wider range of customers developing liquid, suspension, semi-solid, and suppository prescription drugs.
U.S. Market Growth for Suppositories and Other Dosage Forms
The contract development and manufacturing market for liquid, suspension, semi-solid, and suppository drugs is poised for significant growth in the coming decade. North American manufacturers are expected to play a key role in this growth. In particular, the U.S. and Canada suppositories market is projected to reach $1.3 billion by 2035, a clear indication of the increasing acceptance of this dosage form in the pharmaceutical market.
LGM Pharma’s investment will ensure that its Rosenberg site is positioned to meet this growing demand by expanding its ability to manufacture topical products, suppositories, and other prescription drug formats. This capacity increase will help the company better serve both current and future customers in a rapidly evolving market.
Elevating U.S.-Based Manufacturing Standards
Hamilton Lenox, Chief Commercial Officer of LGM Pharma, emphasized the importance of the Rosenberg 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.”
This expansion will also include track and trace serialization capabilities, in alignment with regulatory requirements. This technology will enhance product traceability and ensure that the company is in full compliance with evolving regulations. It will also provide a valuable solution to the growing need for transparent, reliable supply chain management.
Supporting a Resilient U.S. Pharmaceutical Supply Chain
With ongoing supply chain disruptions, trade uncertainties, and global challenges affecting pharmaceutical manufacturing, LGM Pharma’s investment in U.S.-based manufacturing facilities is a timely and strategic move. The expansion of the Rosenberg site will provide a dependable, domestic solution to the challenges facing pharmaceutical companies today. By investing in both infrastructure and quality systems, LGM Pharma is positioning itself as a leader in the industry, committed to meeting the increasing demand for high-quality, domestically produced prescription drugs.
Conclusion: An Invitation to Explore Expanded Capabilities
As LGM Pharma continues to grow, companies developing 505(b)(2), New Drug Applications (NDA), ANDA, branded, or generic prescription drug products are encouraged to explore the expanded manufacturing capabilities of the Rosenberg facility. For more information about LGM Pharma’s services and how its new capabilities can support drug development projects, interested parties can visit LGMPharma.com.
This $6 million investment marks a significant milestone for LGM Pharma as it strives to meet the future demands of the pharmaceutical industry while reinforcing its commitment to U.S.-based manufacturing excellence.
About LGM Pharma
LGM Pharma is a leading contract development and manufacturing organization (CDMO) providing comprehensive Active Pharmaceutical Ingredient (API) sourcing, drug product CDMO services, and contract analytical testing services to the pharmaceutical, biotechnology, and compounding pharmacy industries. LGM Pharma assists clients in managing all phases of the drug product development process, from API sourcing through to drug product commercialization. LGM Pharma’s extensive global network of qualified API partners enables clients to optimize supply chain management and distribution. Services include API sourcing and procurement, formulation development, analytical method development, method and process validation, ANDA / NDA submission, stability studies, and raw material and finished product testing and packaging.
LGM Pharma is committed to quality and has a long-established positive regulatory track record, providing expert regulatory and market intelligence services to its clients. The company is focused on customer service and customized solutions, providing clients with a comprehensive U.S.-based manufacturing solution that reduces risk, increases efficiency, and accelerates the path to commercialization. For more information, visit LGMPharma.com.
