LGM Pharma Unveils Enhanced Analytical Testing Services and Expands CDMO Portfolio with Additional Suppository Manufacturing Capabilities

—50% expansion and over $2 million investment in standalone analytical testing services (ATS); offers greater flexibility and agility to address evolving needs—

—Growth of suppository manufacturing capabilities addresses increasing market demand to meet the needs of geriatric and pediatric patients, and women’s health—

—Learn about LGM Pharma’s diverse offering of CDMO services at 2024 DCAT week—

BOCA RATON, Fla.–(BUSINESS WIRE)–#ANDA–LGM Pharma, a leading provider of tailored API and CDMO services for the full drug product lifecycle, today announced a significant enhancement of its capabilities: a 50% expansion and an investment exceeding $2 million in its standalone offering for Analytical Testing Services (ATS) alongside the introduction of new suppository manufacturing capabilities to its contract development and manufacturing (CDMO) portfolio. These strategic enhancements provide additional internal bandwidth for growth while also providing customers greater flexibility with a streamlined, efficient, and comprehensive solution for their manufacturing needs.

Standalone Analytical Testing Services

With a broad array of analytical testing capabilities for small-molecule drug substances and drug products, LGM Pharma can meet the demands of large and small clients, from established pharmaceutical companies to start-ups. In addition to analytical testing, the company provides comprehensive method development and validation services, as well as stability testing, including real-time and accelerated stability studies. LGM Pharma’s analytical laboratories, located at the CDMO’s facility in Irvine, California, are equipped with state-of-the-art chromatography and spectroscopy instrumentation, including ICP-MS and ICP-OES, to exceed the industry’s highest standards.

“Offering standalone analytical testing expands our agility and capacity to serve as a strategic resource for our pharmaceutical partners, providing them with flexibility to meet the precise needs of their expanding product portfolios,” said Prasad Raje, Ph.D., Chief Executive Officer at LGM Pharma. “With our continuum of robust and tailored support services, we enable pharmaceutical companies to get to market faster and achieve sustainable success in today’s complex market.”

“We take a rigorous, multi-disciplinary approach to address our customers’ most complex analytical needs,” said Shailesh Vengurlekar, Senior Vice President of Quality & Regulatory Affairs at LGM Pharma. “Our team consists of more than 60 quality and analytical specialists who have decades of experience in all aspects of analytical testing, method development, and validation. We are proud of our excellent track record and our history of success supporting clients with the highest quality manufacturing and testing services.”

Suppository Formulation and Manufacturing

As demand for suppositories gains significant traction, especially in the realm of women’s health products, LGM Pharma is expanding its manufacturing capacity at its facility in Rosenburg, Texas. This forward-looking investment aligns seamlessly with the organization’s commitment to meeting the diverse and growing demands of the pharmaceutical industry.

Suppository drug delivery systems enable more direct and efficient drug absorption for precise drug release kinetics, including for high medication concentrations and extended drug release times. They provide an excellent solution for patients with difficulty swallowing pills or those experiencing nausea, as well as for chronic conditions and women’s health.

“As patient needs become increasingly diversified, the pharmaceutical industry needs CDMO partners that can provide specialized capabilities,” said Ian Gibson, Executive Vice President of Operations at LGM Pharma. “Our expertise in suppository formulation development and manufacturing, including the most advanced delivery systems, represents another example of our dedication to providing strategic solutions to our industry partners.”

To learn more about LGM Pharma’s unique suite of ATS services and drug product CDMO services, including suppository manufacturing, interested parties can request a meeting with company executives at 2024 DCAT Week, March 18–21, in New York City, by emailing [email protected].

About LGM Pharma

LGM Pharma is a leading contract development and manufacturing organization (CDMO) providing comprehensive Active Pharmaceutical Ingredient (API) sourcing and drug product CDMO solutions 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 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 a comprehensive one-stop manufacturing solution that reduces risk, increases efficiency, and accelerates the path to commercialization. For more information, visit lgmpharma.com.

Contacts

Media:
Charya Wickremasinghe, Ph.D.

Brandwidth Solutions

[email protected]