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LGM Pharma will offer contract analytical testing and stability services to pharmaceutical developers and manufacturers.
LGM Pharma announced in a July 8, 2021 press release that it will now offer contract analytical testing and stability services to pharmaceutical developers and manufacturers, including compounding pharmacies. The company already conducts analytical services as part of its integrated contract development and manufacturing (CDMO) activities but is now offering its analytical services expertise and facilities as a standalone contract service.
“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, in the press release. “Our innovative approach to analytical and stability testing focuses on translating our deep understanding of data into actionable results.”
Vengurlekar noted that the company’s acquisition of Nexgen Pharma’s CDMO business in 2020 expanded its capabilities and facilities, allowing LGM Pharma to offer the contract testing service.
The company’s services include comprehensive analytical method development and validation processes that meet all current good manufacturing practice requirements and International Conference on Harmonisation (ICH) guidelines. LGM Pharma analyzes samples using accepted pharmacopoeia methods, and its on-site stability chambers are maintained per ICH guidelines. Testing provides the evidence needed to support shelf-life claims for FDA regulatory filings.
Source: LGM Pharma