Angelini Pharma – High-Potent API: strategy and legacy

From APIs to HPAPIs: A Strategic Evolution

The pharmaceutical industry is undergoing a deep transformation, with significant growth seen particularly in the oncology and drug markets. HPAPIs, known for their high efficacy even at low doses, play a critical role in these areas.

Recent market studies show that the global HPAPI market will grow each year, with an average annual increase of 8.6% from 2023 to 2030. This growth will mainly be driven by different factors, as increase in chronic diseases, advancements in drug delivery technologies and growing demand for customized therapies.

As an historical API manufacturer, we recognized the need to evolve alongside these trends to meet the demands of a rapidly shifting market.

Our company’s decision to venture into HPAPI production was the result of a long-term strategic assessment. With over 50 years of experience in API manufacturing, we have built a reputation for quality, safety, and regulatory compliance cornerstones that are critical for success in the HPAPI sector. These strengths, combined with our deep understanding of complex chemistries, have positioned us to effectively address the unique challenges of HPAPI production.

State of the Art in Angelini’s HPAPI Production

Producing HPAPIs brings challenges and opportunities. Unlike conventional APIs, HPAPIs require specialized facilities, cutting-edge containment technologies, and stringent safety protocols because these compounds are highly potent. Consequently, ensuring the safety of personnel, preventing cross-contamination, and maintaining environmental compliance is very important.

To meet these challenges, we have invested in state-of-the-art infrastructure, including isolated manufacturing environments, advanced air-filtration systems, and closed-loop handling processes.

Currently, in our site, there are 3 “the state of art” HPAPI suites which can guarantee high level of containment (from OEB 4 to OEB 6) and different Batch size ranges.

In addition to our technical capabilities, our team brings a wealth of expertise in process development, optimization, and scale-up. Our scientists and engineers have successfully tackled complex synthetic pathways in API production, giving us a significant edge in developing HPAPI processes that are both efficient and scalable.

Building on a Legacy of Excellence

Our journey into HPAPI production builds on decades of experience in API manufacturing, since 1967.

In our Aprilia plant, with a Total Chemical Plant Capacity 1,250 MT/year, we stably produce more than 350 MT/y of final APIs by batch and by flow chemistry.

Our products are distributed in both of Generic and Captative market worldwide and, for internal use, to our mother house Angelini Pharma.

Along our experience, longer than fifty years we have consistently demonstrated our ability to deliver high-quality products.

This legacy of excellence provides several advantages as we expand into the HPAPI market such, as:

• Expertise in Complex Chemistry: Our extensive R&D knowledge allows us to develop robust, scalable manufacturing processes for HPAPIs.
• High GMP Standards: Approved by AIFA since 1975, we maintain a culture of quality, safety, compliance, and continuous improvement to meet international standards
  (ANVISA, FDA, PMDA).
• Regulatory Expertise: Our proven experience ensures our HPAPI production adheres to all necessary regulatory requirements, from facility design to product release.
• Focus on Safety and Sustainability: We prioritize employee safety, environmental protection, and product integrity by investing in advanced containment technologies.
• Customer-Centric Approach: We deliver tailored solutions, including custom synthesis, process development, and technical support, based on a strong client relationships.

Conclusion

The decision to enter the HPAPI market represents a natural progression for our company, aligning with both industry trends and our historical background in Fine Chemical production.

By leveraging our robust experience in API manufacturing and investing in state-of-the-art facilities and technologies, we are well-positioned to meet the growing demand for high-potency pharmaceuticals. As we continue to expand our capabilities, our mission remains the same: to deliver high-quality, innovative solutions that improve patient outcomes.

References and notes

• “Global High Potency Active Pharmaceutical Ingredients (HPAPI) Market Report,” Market Research Future, 2023.
• “ICH Guidelines for Good Manufacturing Practice,” International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use.
• “The Role of HPAPIs in Targeted Drug Therapies,” Pharmaceutical Technology, 2023.
• European Medicines Agency (EMA) official guidelines on HPAPI manufacturing and handling.