LGM Pharma has acquired the CRO Sannova Analytical, expanding its testing capabilities and increasing its capacity to handle more pharmaceutical development work.
Sannova will continue to operate under its own name as Sannova Analytical, led by its current management team. LGM also promised customers continuity in their scientific teams, validated methods and contacts.
Sannova provides bioanalytical services for preclinical and clinical studies, including pharmacokinetic and immunogenicity testing and supports biologics and cell and gene therapy programmes.
Its capabilities also include nitrosamine impurity testing and extractables and leachables evaluations. The laboratory has completed more than 1500 GLP studies and 3500 cGMP analytical studies and was most recently inspected by the FDA in 2025 with no action indicated.
LGM will gain new technical capabilities including Good Laboratory Practice (GLP) bioanalysis, nitrosamine impurity testing, genotoxic impurity testing and extractables and leachables evaluations.
The company said the purchase was part of its strategy to build a US-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 Dr Prasad Raje, CEO of LGM Pharma.
"Sannova gives us both, along with a US-based team that develops and validates its methods at the centre 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.
LGM Pharma clients will also gain a cGMP analytical laboratory in the Northeast corridor, along with GLP bioanalytical services and analytical testing available elsewhere in the US.
The acquisition offers clients a single partner for API sourcing, release, stability testing and bioanalysis, supporting manufacturers with NDSRI risk assessments and biotech teams advancing from preclinical studies to Phase 4.
Why this matters
Nitrosamine Drug Substance-Related Impurities (NDSRIs) have been a major regulatory and quality concern in the pharmaceutical industry following discoveries of contamination in certain medicines, including some blood pressure treatments and other widely used drugs.
Some nitrosamines can pose a cancer risk; thus, regulators have established very low acceptable intake limits for many of them.
For NDSRIs in particular, this presents a challenge, as the impurities can be related to the drug's own molecular structure.
Companies may need to set appropriate acceptable intake limits and develop sensitive methods to reliably detect the relevant impurities.
However, routine quality-control methods may not be sensitive enough to measure certain impurities at the required levels and laboratories may need to develop and validate more sensitive analytical methods for specific drug substances and impurities.
With this acquisition, LGM Pharma can now offer customers more support in addressing a difficult and ongoing pharmaceutical quality challenge.
"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,” added Tom Formolo, Partner at New Harbor Capital.
LGM is a differentiated platform in API sourcing and analytical testing services and Sannova is a strategic complement to the business.
"Sannova’s specialised capabilities and strong regulatory record in a rapidly growing segment of the market will make LGM an even more valuable partner to its growing customer base. We are pleased to support the combined team."
