LGM Pharma Launches Standalone Analytical Services for Drug Developers and Manufacturers
─Analytical Testing and Stability Services Covering Both Drug Substance and Drug Product are Available to Clients Through Flexible Arrangements, Including Standard or Preferred Vendor Contracts─
─Learn More About LGM Pharma’s Transformational Acquisition of Nexgen Pharma at DCAT Week 2021─
BOCA RATON, Fla.--(BUSINESS WIRE)--#API--LGM Pharma today announced the launch of its new Analytical Services offering that provides analytical testing and stability services to pharmaceutical developers and manufacturers, including compounding pharmacies. The company, which already conducts analytical services as part of its integrated contract development and manufacturing (CDMO) activities, now is offering its analytical services expertise and facilities as a standalone contract service for pharmaceutical industry clients.
“We are delighted to be able to offer our first-rate analytical and stability testing services to the broader community of drug manufacturers and developers,” said Shailesh Vengurlekar, Senior Vice President, Quality & Regulatory Affairs at LGM Pharma. “Our acquisition last year of Nexgen Pharma’s CDMO business significantly expanded our physical infrastructure and our pool of scientific talent, including specialized facilities, equipment, and staff with extensive expertise in analytic and stability testing. As a result, we now are able to provide a full suite of these services as a standalone option.”
Mr. Vengurlekar continued, “Our innovative approach to analytical and stability testing focuses on translating our deep understanding of data into actionable results. It is complemented by our ability to craft individualized frameworks for our client relationships, spanning one-time projects, preferred vendor relationships, comprehensive drug development and manufacturing partnerships, and everything in-between. We welcome both new and returning clients to learn more about our Analytical Services.”
With a network of CGMP facilities in California, Colorado, and Texas, state-of-the-art chromatography and spectroscopy equipment, and over 60 QA, QC, and analytical staff members, LGM Pharma is well-positioned to deliver high-quality, precise, client-specific, and timely analytical and stability testing and reporting for drug substances, excipients, and drug products. Its services include comprehensive analytical method development and validation processes that follow the highest standards and meet all CGMP requirements and ICH guidelines. LGM Pharma analyzes samples using accepted pharmacopoeia methods and provides comprehensive, high-quality stability services using the company’s on-site stability chambers maintained per ICH guidelines. It takes an innovative approach to developing and validating stability-indicating methods for all forms of drug substance and drug product. LGM Pharma also provides the evidence needed to support shelf-life claims for FDA regulatory filings. For more information on the company’s extensive Analytical Services, visit lgmpharma.com/analytical-services/.
LGM Pharma also announced it will participate in the virtual DCAT Week, July 12-16, 2021. CEO Prasad Raje, PhD, will discuss the company’s transformational integration of the CDMO business of Nexgen Pharma, which it acquired in July 2020. That presentation will be available to DCAT members starting July 12 via the DCAT member portal. For more information, visit https://dcatweek.org/MemberAnnouncementForum.
About LGM Pharma
LGM Pharma is a leading CDMO provider of comprehensive API sourcing and drug product contract development and manufacturing solutions to the pharmaceutical, biotechnology, and compounding pharmacy industries. LGM Pharma assists clients in managing all phases of the drug product development process, from Active Pharmaceutical Ingredient (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 formulation development, analytical methods development, methods and process validation, ANDA / NDA product submission, stability studies, raw material, and finished product testing and packaging. LGM Pharma is committed to quality. It has a long-established positive regulatory track record and provides 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.