Home Medizin LGM Pharma stellt verbesserte analytische Testdienste vor und erweitert das CDMO-Portfolio um zusätzliche Kapazitäten zur Herstellung von Zäpfchen

LGM Pharma stellt verbesserte analytische Testdienste vor und erweitert das CDMO-Portfolio um zusätzliche Kapazitäten zur Herstellung von Zäpfchen

von NFI Redaktion

LGM Pharma, a leading provider of customized API and CDMO services for the entire drug product life cycle, announced today a significant expansion of its capabilities: a 50% increase and an investment of over $2 million in its standalone Analytical Testing Services (ATS). the introduction of new capacities for suppository manufacturing into its Contract Development and Manufacturing (CDMO) portfolio. These strategic enhancements provide additional internal bandwidth for growth while offering customers more flexibility with an optimized, efficient, and comprehensive solution for their manufacturing needs.

Standalone Analytical Testing Services

With a wide range of analytical testing capabilities for low molecular weight drug substances and drug products, LGM Pharma can meet the requirements of both large and small customers, from established pharmaceutical companies to startups. In addition to analytical testing, the company offers comprehensive method development and validation services as well as stability testing, including real-time and accelerated stability studies. LGM Pharma’s analytical laboratories at the CDMO site in Irvine, California, are equipped with state-of-the-art chromatography and spectroscopy instruments, including ICP-MS and ICP-OES, to exceed industry standards.

„The offering of standalone analytical testing expands our flexibility and capacity to serve as a strategic resource for our pharma partners, providing them with the flexibility to meet the exact requirements of their growing product portfolios,“ said Prasad Raje, PhD, Chief Executive Officer at LGM Pharma. „With our continuum of robust and tailored support services, we enable pharmaceutical companies to bring products to market faster and achieve sustainable success in today’s complex market.“

We take a rigorous, multidisciplinary approach to meet our customers‘ most complex analytical testing requirements. Our team consists of over 60 quality and analytical specialists with decades of experience in all aspects of analytical testing, method development, and validation. We take pride in our outstanding track record and success story of supporting our customers with the highest quality manufacturing and testing services.“

Shailesh Vengurlekar, Senior Vice President of Quality and Regulatory Affairs, LGM Pharma

Suppository Formulation and Manufacturing

As the demand for suppositories, especially in the field of women’s health products, continues to rise, LGM Pharma is expanding its production capacity at its facility in Rosenburg, Texas. This forward-thinking investment seamlessly aligns with the organization’s commitment to meeting the diverse and growing needs of the pharmaceutical industry.

Suppository drug delivery systems allow for more direct and efficient drug absorption, precise drug release kinetics, even at high drug concentrations and longer drug release times. They offer an excellent solution for patients with pill swallowing difficulties or nausea, as well as for chronic conditions and women’s health.

„As patient needs become increasingly diverse, the pharmaceutical industry requires CDMO partners who can provide specialized capabilities,“ said Ian Gibson, Executive Vice President of Operations at LGM Pharma. „Our expertise in the development and manufacturing of suppository formulations, including the most advanced delivery systems, is another example of our commitment to providing strategic solutions to our industry partners.“

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