BOCA RATON, Fla.--(BUSINESS WIRE)--LGM Pharma, a leading provider of tailored API and CDMO services for the full drug product lifecycle, today reported strong growth in 2022 in both its long-established Active Pharmaceutical Ingredient (API) division and its new contract development and manufacturing (CDMO) division. LGM acquired its CDMO division in 2020, with full operational integration accomplished in late 2021 for commercial manufacturing and for the two newly-created CDMO service segments - Analytical Testing Services (ATS) and Drug Product Research & Development (R&D).
The strong demand for these service offerings led to 49 ATS and R&D projects booked in 2022, achieving 150% of sales budget in the first full year of operations for these new service segments. Demand in 2022 also remained strong for LGM Pharma’s established API Services division, with over 300 unique APIs delivered and 1700+ imports handled for clients.
Robust customer demand fueled strong growth and investment in the CDMO division’s service segments, which provide analytical testing; method development and validation; formulation development; clinical trial material production and testing; stability studies; regulatory submissions; commercial manufacturing and more. The CDMO division works with multiple dosage forms including oral solid dosages, oral disintegrating tablets, powders, liquids, suspensions, semi-solids and suppositories.
“The strong start posted by our CDMO business reflects our company-wide commitment to supporting customer needs with quality-assured, customer-centric strategies. These strategies are designed to increase speed and flexibility, reduce supply chain risks and improve access to high-quality drug products and APIs. We established the CDMO division to focus on the unmet needs of small to mid-size biopharma firms and are especially proud of the demonstrated speed, agility, and flexibility we employ to meet their distinctive needs,” said Dr. Prasad Raje, Chief Executive Officer of LGM Pharma. “We look forward to continuing strong growth in our CDMO division, where our multiple US-based facilities and experienced technical staff are well-positioned to help companies advance their products through successful commercialization.”
In its API sourcing business, LGM takes a bespoke approach to meeting a client’s overall objectives. By understanding the full life cycle of a product upfront, LGM can address their API sourcing needs in a sustainable and scalable way. Clients also get access to a highly scrutinized and qualified network of innovative API manufacturers - developed over decades - which allows LGM to provide clients with unique services, such as supplying novel and hard-to-source APIs that are quality-assured and compliant with US regulations.
Dr. Raje continued, “The value of our custom API sourcing strategies for clients has never been more apparent than in the current era, with supply chain issues remaining a major challenge for drug manufacturers. Our continuing success in growing this business is built on several key principles. First is our ongoing commitment to quality and continuous improvement in our quality-focused processes and procedures, where we have made significant investments over the past several years. Another key success factor is our proactive approach to working with clients on risk mitigation, using tactics such as pulling shipments forward, increasing safety stock, proactively addressing possible delays, and finding alternate manufacturing sources when needed. This combination of quality focus and proactive risk mitigation has earned us the trust and loyalty of a growing customer base.”
LGM Pharma brings its pharmaceutical customers more than 100,000 square feet of specialized equipment, manufacturing and warehouse facilities in California, Colorado, Florida, Kentucky, and Texas; expert staff with over 100 years of combined drug development expertise; an unparalleled global network of prequalified CGMP API manufacturers with more than 6,000 APIs delivered to clients in the last three years; a rigorous commitment to quality that spans every aspect of the company’s business; and a belief that customers are best served as partners, working collaboratively with LGM Pharma to craft individualized frameworks to optimize their projects.
To learn more about LGM Pharma’s unique suite of API services and drug product CDMO services, request a meeting at info@lgmpharma.com with company executives at 2023 DCAT Week, March 20-23, in New York City.
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.
