Solid Dose Manufacturing with High-Potency APIs

As a global leader in solid dose manufacturing, we specialize in the processing and manufacturing of drug products containing high-potency active pharmaceutical ingredients (HPAPIs), including those for oncology, hormones, and hormone-like therapeutics.With a proven track record manufacturing using highly potency solid ingredients, our facilities and expertise are optimized to handle externally sourced high-potency materials safely and efficiently.

Expertise in Manufacturing with High-Potency API

Our HPAPI manufacturing services cover the entire development and production lifecycle - from formulation and technical transfer to full-scale commercial supply. With dedicated high-containment facilities designed to meet the strictest safety and regulatory requirements, you can be sure of full protection of products, patients, and the environment.

With purpose-built high-containment facilities that meet stringent global safety and regulatory standards, we ensure complete protection of products, patients, and the environment while offering expert manufacturing of both novel and generic high-potency solid dosage forms in batch sizes from 0.5 kg to 500 kg.

Why Choose Aenova for HPAPI-Based Drug Product Manufacturing?

Experts in high-potency drug production up to OEB 5
State-of-the-art containment technologies for safe and compliant HPAPI manufacturing
Comprehensive GMP-approved facilities with a strong track record of global regulatory inspections
Integrated supply chain and full-service manufacturing for seamless production and delivery

Key Capabilities for Oncology Drug Manufacturing

Aenova is a leader in manufacturing solid dose forms using externally supplied HPAPIs for hormone-based and hormone-like drugs. We support advanced bulk production with robust closed-containment systems, alongside customized packaging services tailored to a wide range of solid dosages.

Production of all major solid dosage forms
Flexible batch sizes to meet clinical and commercial needs
Hormones & hormone-like drug manufacturing
Custom plant-in-plant solutions for client-specific requirements

Capacity & Safety Standards

Capacity: Over 1.5 billion units
OEB Level: 3-5

Partner with Aenova for High-Potency Solid Dose Manufacturing

With extensive expertise in high-containment solid dose manufacturing, Aenova provides scalable, high-quality production of drug products containing HPAPIs. From development through to global supply, our integrated services ensure your high-potency formulations are delivered safely, efficiently, and at scale.