Acute Research
R&D-driven API & formulation partner. EU-GMP capable manufacturing • Sterile injectable expertise • Contract R&D & pilot scale services.
Three divisions: API Division • Formulation Division • R&D & Contract Services
About Acute Research
We are an R&D-driven company with a strong QA culture. We specialise in niche, high-value APIs with full regulatory and plant support for customers who demand stringent specs and sterile-use readiness.
Our EU-GMP capable facility features dedicated suites for sterile-use APIs, validated processes, robust stability programs and full documentation packages (DMF / CTD / batch records) for regulated markets.
EU-GMP
Capable Suites
Sterile
Injectable Expertise
DMF/CTD
Documentation
Our mission and strengths
Acute Research Centre (ARC) focuses on novel chemistry and cost-effective technologies to provide early entry opportunities in regulated and emerging markets. We develop APIs and intermediates free from genotoxic impurities, benchmarked to innovator quality.
Our integrated teams bring together chemistry, process engineering, analytical sciences and regulatory affairs. With more than 35 years of experience, patents and publications worldwide, ARC supports the full pathway from route scouting to commercial manufacturing and global submissions.
Development Process
Route Identification
Novel chemistry and process development for APIs and intermediates
Scale-up & Optimization
Process optimization and scale-up from milligram to kilogram
Analytical Development
Method development, validation and quality control
Regulatory Support
GMP compliance and global regulatory submissions
Ready to Partner with ARC?
Need support with API development, CRAMS, or regulatory dossier preparation? Our team is ready to help you achieve your development goals.
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