— Somerset, N.J. Laboratory Adds GLP Bioanalysis, Genotoxic and Nitrosamine Impurity Testing, and Extractables and Leachables Evaluations —

— Sannova Clients Keep Their Team, Methods, and Contacts While Gaining Access to LGM Pharma's API Sourcing and Regulatory Intelligence —

LGM Pharma, a leading provider of tailored API sourcing, contract analytical testing, and drug development services, today announced it has acquired Sannova Analytical, a contract research laboratory headquartered in Somerset, N.J. The acquisition expands LGM Pharma’s analytical testing services business by adding Good Laboratory Practice (GLP) bioanalysis, including peptide and oligonucleotide testing, and by bringing genotoxic and nitrosamine impurity testing, extractables and leachables evaluations, and additional elemental impurities testing to LGM Pharma’s existing cGMP analytical services. Sannova will continue to operate under its own name as Sannova Analytical, led by its current management team.

The acquisition is part of LGM Pharma's strategy to build a U.S.-based analytical services platform alongside its API sourcing business.

"Over the last five years, we've built analytical testing into a standalone business, and the two things our clients keep asking for are bioanalysis and more extensive impurity work," said Prasad Raje, Ph.D., CEO of LGM Pharma. "Sannova gives us both, along with a U.S.-based team that develops and validates its methods at the center of the Northeast pharmaceutical corridor. This acquisition provides additional capabilities, but it also adds capacity for the growing volume of work our clients are bringing to us."

Sannova clients will keep the same scientific team, qualified methods, and contacts they work with today, and gain access to LGM Pharma's API sourcing and its regulatory and market intelligence services. LGM Pharma clients will gain a cGMP analytical laboratory in the Northeast corridor, along with GLP bioanalytical services and analytical testing available throughout the U.S. The acquisition gives clients a single partner for API sourcing, release and stability testing of APIs and drug products, and bioanalysis, whether they are manufacturers working through nitrosamine drug substance-related impurity (NDSRI) risk assessments or biotech teams moving a program from preclinical studies through Phase 4.

Sannova quantifies drug and metabolite concentrations in biological matrices from preclinical and clinical studies in support of pharmacokinetic, toxicokinetic, bioequivalence, and immunogenicity programs, including anti-drug antibody assays. It also supports biologics and cell and gene therapy programs with immunoassay and PCR-based methods. The Somerset laboratory validates its methods in accordance with the international harmonized guideline (ICH M10) on bioanalytical method validation and sample analysis, and it has completed more than 1,500 GLP studies.

In addition to the analytical testing support offered by LGM Pharma to its cGMP customers, Sannova brings expertise in nitrosamine impurity testing. FDA's guidance on control of nitrosamine impurities and its acceptable intake limits for NDSRIs set thresholds too low for routine QC methods to detect reliably, creating sustained demand for sensitive, reproducible trace-impurity testing. Sannova also conducts extractables and leachables evaluations, which identify compounds that can migrate into a drug product from container closure systems, single-use manufacturing components, and delivery devices. The company has completed over 3,500 cGMP analytical studies, and its laboratory is DEA-registered for Schedules II through V controlled substances. Sannova operates under both cGMP and GLP and has been inspected by FDA under each, most recently in 2025 with no action indicated.

"Our clients chose Sannova for the people and methods behind their data, and those stay in place," said Malleswar Kollu, president and CEO of Sannova Analytical. "LGM Pharma's backing lets us continue investing in our scientists, instruments, capacity, and client services faster than we could independently."

"We are excited to continue building LGM Pharma behind our strong and experienced management team,” said Tom Formolo, partner at New Harbor Capital. “LGM Pharma is a differentiated platform in API sourcing and analytical testing services, and Sannova is a strategic complement to the business. Sannova’s specialized capabilities and strong regulatory record in a rapidly growing segment of the market will make LGM Pharma an even more valuable partner to its growing customer base. We are pleased to support the combined team."

Fairmount Partners served as financial advisor and Goodwin Procter served as legal counsel to Sannova Analytical. Reed Smith served as legal counsel to LGM Pharma.

Drug developers, generics manufacturers, and contract manufacturers seeking bioanalytical or analytical services are encouraged to visit Sannova.com or meet with the combined team at AAPS PharmSci 360, Oct. 25-28, 2026, in New Orleans (Booth 1202).

About LGM Pharma

Founded in 2005 and headquartered in Boca Raton, FL, LGM Pharma is a leading drug development service organization providing active pharmaceutical ingredient (API) sourcing and contract analytical testing to the pharmaceutical, biotechnology, and compounding pharmacy industries. The company helps clients manage every phase of drug development, from early sourcing through commercialization. Its extensive global network of qualified API partners enables clients to optimize supply chain management and distribution. Services include API sourcing and procurement, analytical method development, method and process validation, ANDA and NDA submission, stability studies, and raw material and finished product testing. LGM Pharma is committed to quality and provides expert regulatory and market intelligence services. Its customer-focused, U.S.-based team helps reduce risk, increase efficiency, and accelerate the path to commercialization. LGM Pharma is a portfolio company of New Harbor Capital. For more information, visit LGMPharma.com.

About Sannova Analytical

Founded in 2006 in Somerset, NJ, Sannova Analytical is an FDA- and DEA-registered contract research laboratory supporting both small and large molecule drug modalities. Sannova provides cGMP chemistry, manufacturing and controls (CMC) analytical testing for characterization and release of clinical and commercial material, as well as GLP bioanalytical testing services in support of preclinical animal and clinical human sample analysis. The company serves pharmaceutical, biotechnology, generic drug, and CDMO companies, along with clinical research sites. Its CMC practice includes method development and validation, stability testing, and impurities analysis, with a specialization in nitrosamine and NDSRI testing, as well as extractables and leachables evaluations. Its bioanalytical practice supports pharmacokinetic, toxicokinetic, bioequivalence, and immunogenicity programs, with methods validated in accordance with ICH M10. Sannova’s capabilities span across small molecules, peptides, and oligonucleotides. Sannova is FDA-inspected and audited by its clients. For more information, visit Sannova.com.

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@lgmpharma Acquires @SannovaCRO, Expanding cGMP Analytical and GLP Bioanalytical Services