Small Molecule Manufacturing

Small Molecule Manufacturing

We help pharmaceutical innovators bring APIs and intermediates from development to commercial reality. With more than 50 years of GMP manufacturing experience and expertise in advanced chemistry, our small molecule specialists deliver scalable solutions spanning process development, HPAPI, continuous flow, and biocatalysis.

Commercial Manufacturing

One Partner, Every Stage

From late-stage development to commercial manufacturing and final API micronization, we act as one integrated partner across the small molecule lifecycle. The majority of our activities support Phase III and commercial products, where reliability, compliance, and supply continuity are critical.

In parallel, we selectively engage in Phase I–II programs, where strategic route redesign and sustainability improvements unlock maximum value early on. Projects are seamlessly managed across batch and continuous flow, including process intensification where beneficial.

Beyond small molecules, we also integrate peptides and oligonucleotides within the same ecosystem, ensuring continuity, flexibility, and performance at every stage.

What Sets Our Small Molecule Services Apart

Small Molecule Services

Deep Expertise in Challenging Chemistry

We combine deep expertise in hazardous chemistries — such as azide, nitration, and hydrogenation — with a highly solution-driven mindset. We proactively think alongside our customers, flexibly adapting to evolving needs to deliver safe, robust, and scalable processes up to OEB5.

Trusted & Reliable for Over 50 Years

With over 50 years of experience, we are a trusted partner for reliable API supply at the highest quality standards. Our strong regulatory track record is matched by open, transparent communication, building long-term trust through consistent performance and close customer collaboration.

Innovative Approaches to Manufacturing

We combine advanced chemistry with innovative manufacturing and supply strategies. From continuous flow, biocatalysis, and emerging technologies to in-house engineered equipment, PAT integration, and dual sourcing strategies, we continuously redefine process performance, operational excellence, and supply reliability.

Sustainability Leadership

Sustainability is embedded in both our process design and manufacturing. We transform processes into more atom-efficient, lower-impact routes using advanced chemistry and continuous flow, supported by our proprietary EcoPass tool and sustainable operations practices, making us a strong partner for SBTi-driven organizations.

Solving Your Most Challenging Chemistry

We bring deep process expertise and specialized solutions to help you develop, scale, and manufacture complex APIs and intermediates with confidence.

50+

Years of API manufacturing experience

920m³+

Total Reactor Capacity Across Network

19

Successful FDA inspections

2.5B

Doses produced annually

Small Molecule Commercial Supply

API Development and Manufacturing Services

Customers come to us when the chemistry is complex, the commercial launch needs peace of mind, the process must improve, or sustainability targets seem out of reach. Combining advanced process development expertise with proven commercial manufacturing capabilities, we help pharmaceutical partners transform complex APIs and intermediates into robust, scalable, and more sustainable commercial products.

Our Specialized Services

For programs with specialized process, safety, or sustainability requirements, we offer advanced capabilities designed to address challenging manufacturing needs and enable robust, scalable solutions.

Continuous Flow

Continuous Flow Chemistry

Advanced flow chemistry for hazardous, high-energy or heat-sensitive reactions where process control, safety and consistency are critical.

HPAPI

HPAPI Manufacturing

Dedicated high-potency manufacturing capabilities with OEB4/OEB5 containment, long-standing HPAPI experience, and site-specific capacity to be confirmed.

Sustainability

Sustainable Chemistry

Programs for successful green-route development based on biocatalysis, water-based chemistry, selective chemistries, solvent recovery & biosolvents, precious group metals recovery.

Development and Manufacturing Facilities

Balen Facility

Balen, Belgium

Balen supports commercial GMP manufacturing of small molecule APIs and continuous flow chemistry technologies. Processes built for scale-up, sustainability, and long-term supply.

Wetteren Facility

Wetteren, Belgium

Wetteren provides small molecule process development, GMP manufacturing capabilities, and continuous flow chemistry. Supporting complex chemistries and manufacturing requirements for scale-up and commercial production.

India Facility

Visakhapatnam, India

Visakhapatnam provides commercial manufacturing of small molecule intermediates, supporting GMP production for global programs.

Continuous Improvement

Our Approach to Continuous API Improvement

We support API programs across the full lifecycle — not simply by scaling processes, but by continuously unlocking new value as products evolve. Driven by an operational excellence mindset, our teams proactively improve yield, robustness, safety, sustainability, and cost competitiveness through structured continuous improvement programs.

We are particularly strong in transforming customer processes into fundamentally safer and more sustainable manufacturing routes, leveraging continuous flow, biocatalysis and atom-efficient chemistry, supported by dedicated process safety expertise and proprietary sustainability assessment tools.

Unleash Your Small Molecule
Program’s Potential

Frequently Asked Questions

How do you manage technology transfer and project onboarding?

Every project starts with a structured kick-off that establishes clear objectives, responsibilities, and timelines. From there, dedicated project management, biweekly governance meetings, and agreed reporting keep all stakeholders aligned. Every campaign concludes with a joint performance review covering both technical outcomes and collaboration effectiveness. This operational excellence-driven approach ensures rapid knowledge transfer, transparent communication, and continuous improvement from onboarding through commercial supply.

Will I have clear points of contact throughout the project?

Yes. Every customer benefits from two dedicated contacts: a Key Account Manager for commercial matters and a Project Manager for technical and operational execution. In parallel, direct interactions between the customer and Aji Bio-Pharma subject matter experts are actively encouraged. This combination of clear accountability and open communication enables faster decisions, stronger alignment, and more effective problem-solving throughout the project lifecycle.

Are there limitations to the types of projects you can handle?

Very few. From hazardous reagents and highly potent compounds to quality-critical, safety-sensitive and environmentally demanding processes, we routinely support projects that push the boundaries of pharmaceutical manufacturing. By combining advanced containment, process safety expertise, continuous flow and biocatalysis, we can safely develop, scale and manufacture an exceptionally broad range of APIs and intermediates. The added advantage: customers often improve both manufacturing performance and sustainability metrics, supporting increasingly ambitious Scope 3 targets at the same time.

How do you ensure sufficient manufacturing capacity for my product?

Capacity planning starts with transparency. Through regular risk-adjusted forecasting and close customer collaboration, we translate anticipated demand into long-term capacity strategies across our manufacturing network. This enables proactive resource planning while maintaining flexibility for changing market conditions. The result is a shared multi-year supply vision that minimizes supply risk, supports on-time-in-full delivery, and gives customers the confidence to plan their business with certainty.

How do you approach analytical development and analytical support?

Analytical development is integrated from the earliest stages of every project. Depending on customer needs, we can transfer existing methods or develop and validate them internally using an extensive analytical toolbox and advanced PAT capabilities. Because analytical expectations continue to evolve throughout development and commercialization, we focus on early alignment and transparent communication, helping customers reduce risk, avoid delays, and maintain control over quality throughout the product lifecycle.