API Division — Overview

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.

Production Facility

EU-GMP capable facility with dedicated suites for sterile-use APIs, validated processes, robust stability programs and full documentation packages (DMF / CTD / batch records) for regulated markets.

Product Snapshot

Why partner with Acute

• Turnkey support from lab to commercial batches.
• Documentation packages and regulatory support ready for submissions.
• Experience handling sterile injectable APIs and tight internal specs.
• Niche, high-value APIs with full regulatory and plant support.

Formulation Division

Focused portfolio of sterile injectables and topical formulations — lyophilization expertise for stable parenteral presentations and topical wound-care solutions.

Selected Products

• Tigecycline — Sterile lyophilized powder for IV infusion (50 mg/vial, single-dose)
• Naftifine HCl — Topical 1% and 2% cream/gel (15g–90g tubes)
• Feracrylum — Gel 1% & 3% and 1% sterile antiseptic solution for wound care

Capabilities

• Lyophilization cycle development and optimization
• Sterile injectable formulation development
• Topical formulation expertise
• Small clinical batch support

R&D & Contract Services

State-of-the-art analytical and process R&D labs. Flexible FTF / FFS / lab-on-rent models with pilot scale and method validation services. Our R&D suites support bench and small pilot-scale process development, analytical method development, formulation lab work and lyophilization cycle development.

Core R&D Capabilities

• Benchtop process development — glass and small stainless reactors for reaction scouting and optimization
• Formulation lab — excipient screening, stability screening, lyophilization cycle development
• Analytical & method development — HPLC/UHPLC, GC, FTIR, UV-Vis and method validation
• Pilot utilities — pilot lyophilizer access, small-scale filtration and centrifugation

How R&D supports your project

• End-to-end development: reaction optimisation → impurity profile resolution → analytical method & stability testing
• Lyophilization cycle development, vial fill optimisation and small clinical batch support
• Method transfer and tech-transfer packages ready for pilot / commercial scale-up

Acute Chemtech

Acute Chemtech is our manufacturing & scale-up vertical. For commercial-scale operations and purchase enquiries please contact the team.

Facility Highlights

• EU-GMP capable suites
• Lyophilization & sterile fill expertise
• Analytical method development & stability labs
• Regulatory documentation & DMF support