Expertise in HPAPIs & Ophthalmic APIs

Advanced containment, integrated R&D, and regulatory excellence for highly potent and ophthalmic APIs.

At Inke, we have built a reputation for excellence in the development and manufacturing of Highly Potent Active Pharmaceutical Ingredients (HPAPIs) and ophthalmic APIs. Our expertise covers the entire process — from early-stage research and API development to commercial-scale GMP manufacturing — supported by state-of-the-art high-containment technologies and a fully integrated R&D environment.

This holistic approach ensures operator safety, regulatory compliance, and production efficiency at every stage of the product lifecycle, making Inke a trusted European HPAPI and ophthalmic API manufacturer serving pharmaceutical partners worldwide.

High-Containment Design for Maximum Safety and Compliance

Handling highly potent APIs requires uncompromising safety standards and advanced engineering solutions. At Inke, our high-containment facilities are designed according to SafeBridge® guidelines and classified as OEB 4, ensuring occupational exposure levels below 30 ng/m³. This guarantees operator protection, environmental safety, and product integrity throughout the entire manufacturing process.

Our containment strategy integrates isolator-based systems, downflow booths, and ISO 8 cleanrooms to minimize risk and prevent cross-contamination. Every step—from raw material sampling to final product dispensing—is executed under strict cGMP conditions, supported by continuous environmental monitoring and validated protocols.

Core Elements of Our Containment Strategy

OEB 4 containment design under SafeBridge® standards

Isolator-based synthesis and dispensing for highly potent APIs

ISO 8 cleanrooms for critical operations

 

 

Validated risk assessment protocols for all unit operations

 

 

Continuous environmental monitoring to ensure compliance

Integrated R&D and Manufacturing for Complex APIs

At Inke, we go beyond manufacturing. Our high-containment facility is a fully integrated platform combining research, development, analytical laboratories, and GMP production areas. This structure enables seamless technology transfer and scalability, reducing time-to-market while maintaining the highest safety and quality standards.

From milligram-scale development to commercial quantities, we manage complex synthesis processes and purification steps under strict cGMP conditions. Our advanced equipment includes isolator-based reactors, downflow booths, and high-precision analytical tools such as HPLC, UPLC, and GC, ensuring consistency and reproducibility across all stages.

What Defines Our R&D Expertise

End-to-End Integration – R&D, analytical, and manufacturing under one roof

 

 

 

Seamless Scale-Up – From mg to kilos with validated processes

Advanced Analytical Support – HPLC, UPLC, GC, IR, Karl Fischer

 

 

Isolator-Based Reactors – Controlled synthesis for HPAPIs

 

 

Technology Transfer Expertise – Accelerating development to commercial scale

Advanced Purification Technologies for Maximum Quality

Purification is critical for high-potency APIs (HPAPIs), where even trace impurities can impact safety and efficacy. At Inke, we apply cutting-edge chromatographic purification techniques—both liquid and supercritical—under strict GMP conditions to achieve exceptional purity levels for prostaglandin analogues and other complex molecules.

Our HPAPI purification processes are designed for scalability and reproducibility, ensuring full compliance with US and EU Pharmacopoeia standards. By integrating advanced equipment and validated protocols, we guarantee consistent API quality across all production scales, from laboratory development to commercial manufacturing.

Key Features

  • Liquid Chromatography Expertise – High-resolution separation for complex molecules
  • Supercritical Fluid Chromatography (SFC) – Greener processes with reduced solvent use
  • Validated GMP Processes – Compliance with USP and EP standards
  • Scalable Solutions – From mg to kilos without compromising purity
  • Continuous Optimization – Improving efficiency and sustainability

Explore Our Ophthalmic HPAPI Portfolio

Discover our comprehensive range of ophthalmic HPAPIs, manufactured under EU-GMP and ANVISA certifications. From established prostaglandin analogues to innovative molecules in development, Inke Ophthalmics delivers quality, compliance, and global market readiness.

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Regulatory Excellence for Global Market Access

Compliance is the foundation of our operations. Inke’s HPAPI and ophthalmic API facilities are certified under EU-GMP and ANVISA, meeting the most stringent international standards. We provide full regulatory support throughout the product lifecycle, including ASMF, CEP, and DMF submissions for key prostaglandin analogues and other complex molecules.

Our robust quality systems ensure traceability and conformity with USP and EP pharmacopeias, enabling smooth registration processes and reliable global supply. This commitment to regulatory excellence positions Inke as a trusted partner for pharmaceutical companies worldwide.

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Driving Innovation and Sustainable Manufacturing

Innovation and sustainability are at the heart of our strategy. We continuously optimize processes to improve efficiency and reduce environmental impact without compromising quality. Our transition to supercritical fluid chromatography (SFC) reflects this commitment, minimizing solvent use while enhancing purification performance.

By integrating advanced engineering solutions and continuous process improvement, we deliver high-quality APIs with reduced resource consumption and lower waste generation — supporting a greener and more competitive pharmaceutical supply chain.