LGM Pharma, a number one supplier of tailor-made API and CDMO companies for the total drug product lifecycle, as we speak introduced an funding of over $6 million to increase its Rosenberg, Texas manufacturing facility as a part of its Section I CDMO progress technique. The enlargement will enhance capability for liquid, suspension, semi-solid, and suppository drug merchandise, addressing the rising demand for dependable U.S.-based manufacturing.
This funding comes as LGM Pharma experiences sustained progress in prescription drug tasks, together with 505(b)(2) and Abbreviated New Drug Utility (ANDA) applications. The Rosenberg facility enhancements will accommodate elevated manufacturing volumes whereas guaranteeing compliance with FDA rules and present good manufacturing practices (cGMP). The positioning will stay totally operational all through the enlargement.
LGM Pharma is making strategic investments to help the rising want for high-quality home drug manufacturing,”
Prasad Raje, Ph.D., CEO, LGM Pharma
“We’ve got a number of prescription merchandise in growth, together with each 505(b)(2) and ANDA tasks, with one ANDA already submitted to the FDA. This enlargement ensures we will proceed offering our clients with the standard, reliability, and confidence they should deliver these merchandise to market.”
Increasing capability to satisfy market demand
The contract growth and manufacturing marketplace for liquid, suspension, semi-solid, and suppository medication is projected to see vital progress over the following decade, with North American producers taking part in a key function. The U.S. and Canada suppositories market is projected to succeed in $1.3 billion by 2035, reflecting growing acceptance of this dosage kind.
LGM Pharma’s funding will strengthen each infrastructure and high quality programs on the Rosenberg facility, enhancing its capacity to fabricate prescription drug merchandise, together with topical and suppository merchandise, whereas sustaining the very best regulatory and high quality requirements.
Hamilton Lenox, Chief Industrial Officer of LGM Pharma, added, “We at present manufacture prescription merchandise at our oral strong dose facility in Irvine, California. The Rosenberg enlargement will elevate this website to the identical excessive requirements, permitting us to help clients creating liquid, suspension, semi-solid, and suppository prescription drug merchandise with the identical stage of experience and high quality assurance from a U.S.-based manufacturing website.”
Strengthening U.S. pharmaceutical manufacturing
As provide chain disruptions, tariffs, and world uncertainties proceed to impression pharmaceutical manufacturing, LGM Pharma’s funding supplies a reliable home resolution. The enlargement additionally consists of monitor and hint serialization capabilities on the Rosenberg facility, aligning with regulatory necessities to boost product traceability and guarantee compliance.
Corporations creating 505(b)(2), NDA, ANDA, branded or generic prescription drug merchandise are inspired to discover LGM Pharma’s expanded manufacturing capabilities by visiting LGMPharma.com or assembly with firm executives at DCAT Week (March 17-20, 2025) in New York Metropolis.
