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news.LGM Pharma has announced more than $6m investment to expand its manufacturing facility in Rosenberg in the US state of Texas.
The investment is expected to improve the site's capacity to produce prescription drug products. Credit: Hal Gatewood on Unsplash.
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This initiative is stated to be a part of the company’s Phase I contract development and manufacturing organisation (CDMO) growth strategy.
In response to the growing need for dependable production in the US, the expanded facility will help the company to enhance capacity for suspension, liquid, semi-solid, as well as suppository drug products.
The investment comes as the company experiences growth in prescription drug projects, which include 505(b)(2) and abbreviated new drug application (ANDA) programmes.
The enhancements at the facility are designed to support higher production volumes while maintaining compliance with Food and Drug Administration (FDA) regulations alongside current good manufacturing practices (cGMP). Throughout the expansion, the site will continue to operate at full capacity.
LGM Pharma noted that the investment is expected to boost the infrastructure and also the quality systems at the facility, improving the site’s capacity to produce prescription drug products, including topical and suppository products while upholding regulatory and quality standards.
Additionally, the expansion features the “track and trace serialisation” capabilities at the facility, meeting regulatory demands for product traceability and compliance assurance.
LGM Pharma chief commercial officer Hamilton Lenox said: “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.”
LGM Pharma offers biotechnology, pharmaceutical, and compounding pharmacy sectors with drug product CDMO services, contract analytical testing services, and active pharmaceutical ingredient (API) sourcing.
