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TRUSTED PARTNER FOR
REFERENCE STANDARDS & BEYOND
SINCE 2007
SimSon Has Evolved. For a Healthier World.
SimSon Pharma Limited
SimSon Pharma Limited manufactures and supplies pharmaceutical reference standards, drug impurity standards, nitrosamine impurities, drug metabolites and stable isotope labelled compounds to pharmaceutical manufacturers, CROs and analytical laboratories worldwide.
SimSon was founded in 2007 in Mumbai and today runs four manufacturing and laboratory sites across India. Our work begins where the catalogue ends — with the compound nobody has made, the peak nobody has identified and the standard a filing cannot proceed without.
To become a leading global pharmaceutical and scientific partner, recognized for solving complex chemistry challenges and enabling better outcomes.
To provide innovative, cost-effective and time-bound scientific solutions that help our customers move pharmaceutical research and development forward.
Five capabilities, one accountable partner.
Every standard we make answers a question a laboratory could not answer without it.
Drug Impurity Standards
Pharmacopeial and non-pharmacopeial related substances, degradants and unknown impurities — characterised for regulatory approval.
Nitrosamine Standards
NDMA, NDEA, NMBA and API-specific N-nitroso compounds, with trace-level analytical support for risk assessments.
Deuterated APIs & Isotope Labelled
Deuterated and ¹³C internal standards, reagents and labelled compounds for bioanalysis and advanced research.
Complex Peptides & Polymorphs
Custom peptide impurities, polymorphic forms and controlled-substance impurities supplied under all required licences.
CRO, CDMO & Analytical Testing
Method development and validation, impurity profiling, E&L and stability studies in a US FDA inspected laboratory.
Five stages, one accountable team.
Select a stage to see what happens at it.
Synthesize
Synthesis, isolation and purification run in our own Indian laboratories, from milligrams for a method validation to bulk for a commercial programme.
Where the catalogue ends, our work begins.
Most suppliers ship what is already on a shelf. The requests that reach us are the ones that could not be answered anywhere else.
Rare today, essential tomorrow
Unique impurities, hard-to-find molecules and complex standards with no published route and no commercial source — designed and synthesised from first principles.
Comprehensive characterisation
Identity, purity and assigned value established by NMR, mass spectrometry, IR, HPLC, GC, TGA/DSC and potency by mass balance — every result in the certificate.
Metrological traceability
Traceable to recognised reference standards, with assigned value, uncertainty and supporting calculations. ISO 17034 for production, ISO/IEC 17025 for testing.
From milligrams to metric tons
The same standard, the same documentation, whether you need five milligrams for a method or bulk supply for a commercial programme.
“We started SimSon because the hardest requests in pharmaceutical chemistry were the ones nobody wanted to take.”
D-U-N-S® REGISTERED
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