Being Responsive Towards Customer Needs

Across both our verticals of GDS and CMS, we are staying attuned to the requirements of our customers to deliver high-quality molecules that meet their expectations.

Building a quality-led portfolio

Our expertise in complex chemistry has enabled us to build a rich GDS product portfolio. This, together with our consistent product quality and on-time delivery, has earned us the reputation of being a preferred and reliable supplier for pharmaceutical companies worldwide. During the year, led by our deep domain knowledge and through customer collaborations, we introduced several specialty APIs to further strengthen our GDS product suite. Differentiated for their technological complexities, these new molecules will serve niche customer needs to be a strong driver of future growth. Additionally, we have six/seven molecules that are in late-stage development, of which we are on track to file about 5 DMFs in the current fiscal, assuming there is no significant business disruption. As we grow our GDS portfolio, with particular emphasis on enhancing our differentiated offerings, we are confident of delivering significant added-value to our customers.

Serving across the product lifecycle

Backed by over 30 years of experience and expertise in the API industry, we provide end-to-end support for bringing new molecules to the market under our CMS vertical. The GDS vertical also extends lifecycle management to our customers so that the products retain their edge in the market.

Our CMS vertical provides multiple points of customer engagement, starting from the pre-clinical stage and extending to Phase 3 trials, development and commercialisation. While in the early stages of new molecule development, our complex chemistry capabilities have been instrumental in the acquisition of new projects, in the late-stage development and commercialisation stage, our ability to successfully ramp-up scale and transfer technology has given our customers the confidence to stay with us through the value chain.

Our growing talent and capabilities in the CMS vertical is reflected in the addition of several NCE APIs in New Drug Application (NDA) or commercial stage drugs and support for multiple APIs each year in Phase 2 and Phase 3 clinical candidates. Currently, we have 78 active CMS projects with 23 of them in the late-stage development, which includes molecules in development and Phase 3 stage. While providing long-term revenue visibility and a stable platform to grow the business further, our increasing inflow of late-stage projects is steadily enhancing our reputation as a dependable partner in the product innovation journey.

Working with emerging biotech companies

The pharmaceutical industry is witnessing a growing innovation shift from large biopharmaceutical players to small and medium-sized enterprises. There has also been a rapid growth in the number of virtual biotech companies driving innovation. As these emerging biotech players usually lack the infrastructure, resources and expertise needed to drive innovation and commercialisation, they are increasingly accessing the services of contract development and manufacturing organisations. Outsourcing is also being driven by the emerging biotech players need to lower their drug development and production costs.

Bolstered by our positioning as an API expert, we, at Neuland, are increasingly focused on this customer group. Being a one-stop shop for all API needs, we can meet the complete requirements of emerging biotech companies, resulting in reduced risk and cost associated with technology transfers and faster production and delivery timelines. Our scientific expertise and robust infrastructure further underpin our value proposition as a strategic partner for accelerating innovation while reducing costs.

Raising the bar of competency

Production of sterile APIs is a highly specialised capability that involves several complex processes. Our continued quest to raise the bar of our chemistry capability saw us develop processes for the manufacture of compliant sterile APIs, to further enrich our service offerings. We also successfully demonstrated our ability to map genotoxic impurities for assessing the safety and quality of products. Our genotoxic impurity testing services, carried out for several molecules, received appreciation from many customers.

Chemistry, Manufacturing and Control (CMC) activities involve defining the manufacturing processes, product characteristics and product testing at each stage of the product lifecycle to ensure that the product is safe, effective and consistent between batches. Significant improvements were made in our CMC services to better serve our customers in the regulatory filing of an NDA.

Delivering value-added services

We take pride in our customers’ success, viewing their achievements as our own. Going beyond a transactional relationship, we deliver value-added services that enable them to compress innovation cycles, reduce costs and successfully launch new products. Our earnest endeavour is to be a business partner in every sense by extending our complete scientific and technological support. For instance, with years of experience in API manufacturing, we have a strong understanding of the complications in large-scale production; in the case of our emerging biotech customers, who may not be best placed to envisage the full cycle of a product, we proactively share insights on the commercialisation phase even while their molecules are in the development stage.

Investing in our infrastructure

We recognise the importance of having world-class infrastructure to serve our global customer base. New capacities are being added to our cGMP compliant manufacturing facilities while further investing in strategic backward integration for efficient, scalable and customized commercial manufacturing. Our scientists are provided with best-in-class laboratories, equipment, materials and technologies to deliver innovation that are customers need. Capital investment for the year stood at `105.6 crores, a significant part of which was spent on sophisticated equipment for monitoring and testing of particles, automation, and instruments to help investigate the development of new processes.

(For more details on our new infrastructure and equipment, please refer to pages 24-25).