In this exclusive email interaction with BioPharma APAC, Alessandra Ambruosi, Director & Head of Solid Formulations & Pharm Materials R&D at Merck Life Science, offers a deep dive into the strategic role of Merck’s Formulation & Technology Centre in Navi Mumbai. Positioned as a regional hub for R&D and formulation expertise, the centre is driving customer-centric drug development, solving challenges faced by generic manufacturers, and enhancing global partnerships—all while accelerating time-to-market with cutting-edge technologies.

How does Merck’s Formulation & Technology Centre in Navi Mumbai differentiate itself from other formulation labs, and what unique capabilities does it bring to the pharmaceutical industry?

Merck’s Formulation & Technology Centre in Turbhe, Navi Mumbai, is a next-generation facility integral to the company’s global R&D network. The centre is equipped with cutting-edge tools to optimize drug formulation, overcome complex challenges, and accelerate time-to-market across India, APAC, the Middle East, LATAM, and Africa.

What sets Merck’s Formulation and Technology Centre apart from other formulation labs is its customer driven solutions and commitment to sustainable pharmaceutical development. The centre offers hands-on training, technical consulting, and customised solutions designed to tackle customer-centric challenges in formulation development, production scaling, and troubleshooting, ensuring a tailored approach to industry needs. 

What specific formulation challenges do generic drug manufacturers in India face, and how does Merck’s expertise help overcome these hurdles?

With the rapid advancements in AI, the pharmaceutical and healthcare sectors are undergoing significant transformation. However, challenges remain, such as patent issues, raw material & quality issues, production scalability limitations, and restricted access to the latest technology.

Formulating the ideal pharmaceutical product requires the right excipients, a well-established manufacturing process, and rigorous quality controls at every stage, challenges that Merck’s Formulation and Technology Centre is designed to overcome. By understanding and meeting customer needs with tailored solutions for manufacturing generic versions of patented drugs, the centre enhances the accessibility of pharmaceutical products through innovation and precision. Additionally, the lab ensures the production of high-quality generics with optimal formulations that meet specific dissolution, stability, and efficacy requirements.

How is the centre fostering collaborative research in drug delivery, and what are some of the key areas of focus in dosage form development?

Merck believes in building strong, collaborative research partnerships, and by expanding its capabilities in India, the company reaffirms its commitment to driving growth and fostering long-term partnerships in the pharmaceutical sector. 

Merck’s recently inaugurated Formulation and Technology Centre fosters collaborative research in drug delivery by serving as a knowledge hub for industry-academia collaboration. It offers specialized training, hands-on learning, and research support while facilitating plant training to bridge the gap between theory and industry practice. Additionally, Merck’s experts contribute to seminars and conferences, ensuring continuous learning and knowledge exchange within the scientific community.

The focus of our lab is to provide a collaborative platform where customers can explore novel excipients, understand their unique characteristics, and assess their quality for solid dosage forms. Designed to meet the growing demand for complex formulations and innovative drug delivery systems, our state-of-the-art lab supports customers through every phase— from initial product formulation to scale-up. This facility offers access to advanced technologies to develop solid dosage forms along with numerous strategies for solubility enhancement area. 

With Merck’s expertise and cutting-edge technology, we are committed to helping our customers develop and optimize the next generation of pharmaceutical solutions.

What role does advanced technology play in accelerating the formulation process, and how does this impact time-to-market for new drugs?

The Indian pharmaceutical industry is evolving rapidly, driven by technological advancements in manufacturing processes and therapeutic innovations. The Formulation and Technology centre features advanced technologies such as spray drying, Wurster coating, and melt extrusion, along with research tools like Melt Prep®, NIR spectroscopy, particle size analyzers, rheometers, and predictive formulation tools to expedite drug discovery and formulation research. These advancements help formulation scientists navigate patent challenges, develop novel excipients, and bring high-quality generics to market faster. 

The centre highlights Merck’s dedication to scientific innovation and technological progress, supporting pharmaceutical companies in enhancing drug formulation integrity, optimizing delivery mechanisms, and streamlining their development processes. This accelerates time-to-market for new drugs, ensuring high-quality formulations that comply with strict regulatory and therapeutic standards reach patients more efficiently.

How does Merck plan to leverage this facility to enhance its partnerships with Indian pharmaceutical companies and global players in the generics and biosimilars space?

Merck is committed to assisting its partners in developing formulations that meet the highest standards, using the latest advancements in excipient technology. The company’s formulation lab fosters long-term partnerships with clients allowing them to co-create solutions as they innovate and develop the next generation of therapies. Over the years, the centre has supported more than 1,000 scientists from leading pharmaceutical companies, reinforcing its role in advancing scientific and industry innovation, while enhancing its partnerships with Indian Pharmaceutical companies and global players in the generics and biosimilars space. 

What are the long-term goals of Merck’s investment in this centre, and how do you see it contributing to India’s position as a leader in global drug development and innovation

Merck is at the forefront of R&D in healthcare and pharmaceuticals, bringing real world impact in Life Science, through scientific excellence, industry collaboration, and customer-focused innovation. The Formulation & Technology Centre plays a vital role within this ecosystem, advancing research and development to address industry challenges. 

Beyond India, Merck’s impact extends across APAC, the Middle East, LATAM, and Africa, reinforcing its commitment to shaping the future of drug development on a global scale.

The Formulation & Technology Centre is a key part of this ecosystem. It bridges the gap between research and commercialization, blending global expertise with local market insights to create smarter, more efficient drug development strategies. By working closely with pharmaceutical companies, Merck helps accelerate innovation, tackle industry challenges, and ultimately, bring better medicines to market.

Our vision is to innovate, lead, and manufacture sustainable excipients that transform the pharmaceutical industry. Through cutting-edge research, advanced technology, and an unwavering dedication to quality, we aim to push the boundaries of what's possible in healthcare. 

We are committed to fostering collaboration, expanding our research efforts, and continuously advancing solutions that enhance patient care and drive positive change in the global healthcare landscape.