Artículo

Development of Niche Products at Dr. Reddys API

Defining Niche Products:

Niche products are "limited competition drugs" and differentiated products. Limited competition drugs are generic drugs that are either difficult to make or are not made by many players. Differential products are existing molecules but drugs with different dosages or administration mechanisms.

How does Dr. Reddy's API define "niche products," and what criteria are considered when identifying opportunities in this space?

Patients and customers are at the heart of what we do. For Dr. Reddy's, niche products are those products that fulfil unmet medical needs. Opportunities are identified where the drug products have significant complexities and require a high level of scientific acumen to bring the generic version to the market at an affordable price. We also strive to innovate novel formulations for differentiated niche products with better efficacy and make them available at affordable prices.

What are some examples of niche products that Dr. Reddy is considering, and what is the rationale behind their selection?

Dr. Reddy's launched limited competition drugs like Decitabine, Azacitidine, Divalproex and, Donepezil. Eribulin Mesylate is one of the most complex synthetic drugs that is highly effective in the treatment of Metastatic breast cancer. This drug is available at a very high cost, and not many generic launch versions have come up due to the high complexity involved in its preparation.

Niche products often require innovation. How does Dr. Reddy's API foster a culture of innovation to meet the unique demands of niche markets?

Innovation is a critical element of Dr. Reddy's Purpose: "We accelerate access to affordable and innovative medicines because Good Health Can't-Wait". Our state-of-the-art R&D facility with cutting- edge instruments like SEM accelerates research with the latest technologies. There are digital technology platforms like MAPS that accelerate Innovations. We have a highly talented pool of scientists and active academic collaboration with top universities that ensures timely innovation-led deliveries.

Dr. Reddy's has a State-of-the-art R&D centre in India, the U.K., the U.S. & Mexico and Industry- leading chemistry skills. Experienced in complex generics and formulation. Possess innovative drug delivery platforms such as nanoparticles, liposomes, and microspheres. Robust technology platforms such as synthetic/semi-synthetic peptides chiral chemistry. It is backed by one of the best manufacturing bases in India for seamless execution.

Can you provide examples of innovative approaches or technologies to develop niche products?

One of the niche products of Dr. Reddy's is Eribulin Mesylate, which is a complex synthetic drug used for the treatment of metastatic breast cancer. It has over 19 chiral centres that generate 50,000 possible isomers. It has atypical process requirements like air and oxygen-sensitive reactions, cryogenic reaction conditions, and a complex impurity control strategy.

We have successfully developed this API using the latest technological interventions and active global collaborations across Dr. Reddy's sites and universities. The state-of-the-art and dedicated manufacturing facility ensured seamless production with the right quality.

Niche product development may involve collaboration between various teams. How does Dr. Reddy's API facilitate interdisciplinary collaboration among scientists, technical leads, project managers, and R&D teams?

Dr. Reddy's laboratory has a digital workplace, a network of several technologically connected workplaces without regard to geographic boundaries. Employees can interact in a collaborative working environment regardless of location. Multiple communication channels enable us to stay connected and share files smoothly, uninterrupted, and transparently.

Niche products often cater to specific customer needs. How does Dr. Reddy's API maintain a customer-centric approach when developing niche products?

Dr. Reddy's identifies API that has significant unmet needs in disease areas of global relevance, which is already the core domain of the current R&D group.

Managing the lifecycle of niche products is essential for sustained success. How does Dr. Reddy's API approach lifecycle management for niche products, considering updates, expansions, or diversification?

Dr. Reddy's API has a robust continuous improvement program for the lifecycle management of commercialized products. We have a dedicated team of scientists and regulatory experts engaged in proactively updating product requirements for diversification.