API and CDMO service provider LGM Pharma has invested more than $6m into its US liquid, suspension, semi-solid and suppository drug manufacturing capacity at its site in Rosenberg, Texas.
The expansion is part of the LGM's Phase I CDMO growth strategy, and follows the Trump Administration's recent threats to place tariffs on non-domestic pharmaceutical imports.
Through this extension, the Rosenberg facility will be capable of producing higher volumes of product while ensuring regulatory and cGMP compliance.
According to LGM, the site will remain fully operational throughout the expansion period.
LGM's strategic moves comes at a time when the North American suppositories market is growing significantly — with the niche projected to reach $1.3bn by 2035.
As this dosage form has become more accepted, LGM Pharma has invested into both infrastructure and quality control to more efficiently manufacture prescription drugs products — including topicals and suppositories.
As well as its manufacturing expansion, LGM has incorporated track and trace serialisation capabilities at the Rosenberg facility, which allows the CDMO to provide comprehensive product traceability.
“LGM Pharma is making strategic investments to support the growing need for high-quality domestic drug manufacturing,” said Prasad Raje, CEO of LGM Pharma.
“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 US-based manufacturing site.”
Companies looking to develop 505(b)(2), ANDA, NDA, branded or generic prescription drug products can explore LGM Pharma's novel capabilites by meeting with the company's executives at the upcoming DCAT Week in New York.