Saharsh Davuluri is Vice Chairman and Managing Director at Neuland Laboratories. He steers the strategic direction for the company and oversees R&D, Sales & Marketing, Business Development of Generic APIs, Custom Manufacturing Solution (CMS) and Peptides business. As a Managing Director of the Board, he is responsible for the overall growth performance of the organisation and the realization of its business plan. Some of the other areas that he is directly responsible are Investor Relations, Strategy, IT and operations of the company’s subsidiaries in Japan and the US.

Making room for innovation

Highlights from our discussion with Saharsh Davuluri, Vice Chairman and Managing Director at Neuland Laboratories.

Global challenges

Supply chain issues have been a real challenge for the industry, but Neuland has been steadily focused on rebalancing raw material sources geographically. Over the past few years they have successfully added sources from India, Europe and other parts of the world to their supply network.

Being a specialized API player, Neuland offers fairly unique products and capabilities, so their customers all over the world have remained loyal. The one real challenge has been engaging with customers. The absence of face to face meetings, on site audits, and other activities that have always been performed ‘in person’, have created additional hurdles for new business, in particular. 

Another challenge is rising input costs due to geopolitical issues. While many of these risks cannot be mitigated, the company has been successful in negotiating long-term pricing contracts with suppliers. They also created intermediate manufacturing capacities at their new site, and have focused on backward integration using these newly created capacities where there is value to be unlocked.

Emerging opportunities

We believe that the pharma contract manufacturing and research space is thriving. Venture money and private capital has been flowing steadily to fund biotechnology companies. The biotechs are actively developing new drugs for both unmet medical needs as well as mainstream disease areas. These biotechs are becoming increasingly comfortable with outsourcing to reliable partners like Neuland, and that’s where our focus is right now. 

In the advent of COVID, and the fact that pharma companies have launched therapeutics quickly and helped mankind, some of Neuland’s customers have taken accelerated approaches to bring new therapeutics to market, and the company has had to comply with those accelerated regulatory filings. As drug candidates are leap frogging from Phase 1 to a quick Phase 3, there is demand for scaling up API batches briskly. A key advantage that Neuland had in this environment is that their three API manufacturing facilities are cGMP, inspected by global regulatory agencies, and therefore molecules can be launched anywhere in the world.

Route optimization

Pharma is constantly demanding faster, simpler, more cost-effective manufacturing techniques. Optimising the route for a new product can play a key role in this. Neuland has teams of process chemists, engineers who are dedicated to process optimisation. As the company gears up to scale new APIs, they assign a new team with a fresh perspective and a clear mandate to look for improvements without making significant changes to the registered process. 

“I believe that there is a huge room for innovation in designing processes for API manufacturing,” says Saharsh. “Not just in terms of engineering technologies like continuous flow, but also in leveraging modern ideas coming out academic institutions. In order to meet the expectations of Pharma, CMOs have to dig deeper by investing in process research and where feasible, explore collaborations with universities, research institutes, etc.” 

Scaling up

“Scaling up is definitely the biggest challenge for a company like Neuland,” adds Saharsh. “But it is also our strength and area of focus.”

Neuland has invested heavily in R&D for downstream activities in API manufacturing – including crystallisation, drying and micronisation. The company has created a state-of-the-art Process Engineering lab to study the physical attributes of an API, with an experienced group of process engineers to work on the process. Neuland  also invested in a diverse pilot plant, which gives Neuland’s scientists and engineers a “playground” to get comfortable with the process before it gets into the plant.

“We believe process development, improvement and cost reduction is a continuous activity,” says Saharsh. “We take up phase-appropriate development/improvements after completion of each campaign, so learnings from previous campaigns are applied to the next one.”

The future

Saharsh is excited about the next three years, during which Neuland will be involved in 11 NDA filings. On the generic API side, the company has several DMFs being filed, with exciting market opportunities.

“There is a lot of excitement here in terms of handling large-scale first-time process validations and associated data generation to support these filings,” he says. “We have invested around $17 million into capacity creation for future readiness; some of these molecules are in the CNS space, with high potential sales growth, and Neuland is ready to support these brands for their lifetime, with an uninterrupted supply chain.”

DCAT Week is the premier global event held annually in New York City for companies engaged in the Bio/Pharmaceutical manufacturing value chain. It is hosted by the Drug, Chemical & Associated Technologies Association (DCAT), a not-for-profit, corporate member-supported, and volunteer-led global business development association for companies engaged in the Bio/Pharmaceutical manufacturing value chain. Learn more at