About Acute Research

R&D-driven API & formulation partner with EU-GMP capable manufacturing and sterile injectable expertise

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.

Focus: Newly built, segregation-friendly suites with strict internal specs for sterile injectable APIs and niche pharmaceutical products.

Our Divisions & Expertise

Three specialized divisions working together to provide comprehensive pharmaceutical development solutions from lab to commercial scale.

  • API Division: EU-GMP manufacturing with DMF/CTD support
  • Formulation Division: Sterile injectables and lyophilization expertise
  • R&D Services: FTF/FFS models with pilot scale capabilities
  • Acute Chemtech: Commercial-scale manufacturing operations
  • Regulatory Support: Documentation packages for global markets

Why Partner with Acute Research

Mission: To provide specialized pharmaceutical development solutions with stringent quality standards for sterile-use applications and regulated markets.

Key Advantages:

  • EU-GMP Compliance: Dedicated suites for sterile-use APIs
  • Regulatory Ready: DMF/CTD documentation packages
  • Specialized Focus: Niche, high-value pharmaceutical products
  • Quality Culture: Strong QA with stringent specifications
  • End-to-End Support: Lab to commercial scale capabilities

Our Strengths

Depth of Experience

More than 35 years of experience with patents and publications worldwide, supporting a wide range of APIs, intermediates and dosage forms for global markets.

Integrated Development Model

Cross-functional teams spanning chemistry, scale-up, analytical, quality and regulatory functions ensure seamless progression from lab to plant and to regulatory submission.

Regulatory & cGMP Focus

State-of-the-art facilities, ICH-compliant methodologies and strong GMP culture enable us to support inspections and submissions to US, EU, Canada, India and other global agencies.