Q1. Could you start by giving us a brief overview of your professional background, particularly focusing on your expertise in the industry?

My name is Dr. Sanjay Shukla, and I have spent more than 22 years in synthetic organic chemistry. With a Ph.D. and a deep background in pharmaceutical R&D, my career has centered around API process development, CDMO/CRAMS operations, and technology transfer.

My journey began at Zydus Cadila and Dr. Reddy’s Laboratories, where I focused on process chemistry for important generic APIs—including treatments for Alzheimer’s disease, asthma, and dyslipidemia—and contributed to several patents. I later joined Lupin Laboratories, where I took on tech transfer projects for antihypertensive and cephalosporin drugs. After that, I spent 14 years at Suven Pharmaceuticals as Deputy General Manager – R&D, where I led teams of M.Sc. and Ph.D. scientists. During my time there, I oversaw the development and scale-up of more than 100 APIs and advanced intermediates for major global companies such as Pfizer, BMS, Bayer, Astellas, Teva, and Sumitomo, spanning therapeutic areas including CNS, cardiovascular, anti-infectives, and antivirals.

My main strength is designing innovative, non-infringing, and cost-effective synthetic routes—from initial lab concepts to commercial-scale manufacturing. I place special emphasis on impurity profiling, genotoxic impurity control in line with ICH M7 guidelines, process intensification, and smooth technology transfer, including pilot trials, BPR documentation, and process validation. Over the years, I have contributed to 15 patents (including 5 as a sole inventor) and have regularly managed CDMO projects end-to-end, from responding to RFPs and preparing cost estimates to handling client interactions and commercialization.

In recent years, I’ve held roles as Senior Group Leader at Anupam Rasayan (working on APIs, advanced intermediates, and agrochemicals) and as General Manager – R&D at Kumar Organics. Currently, I’m building an entire R&D function from the ground up for a start-up—setting up infrastructure, recruiting and mentoring a team, and driving early-stage process development. In all these roles, I’ve combined hands-on scientific work with leadership, regulatory compliance (USFDA, ICH, WHO), and a strong focus on patent strategy.

Throughout my career, I've focused on turning complex chemistry challenges into robust, scalable, and commercially viable processes—while also building and nurturing high-performing R&D teams.

Q2. Having worked across APIs, intermediates, and specialty chemicals, where do you see the biggest margin opportunities through better process chemistry rather than capacity expansion?

That’s a question I genuinely enjoy answering, because it really gets to the core of what process chemistry can achieve—beyond just adding expensive new capacity. Drawing from my work with APIs, intermediates, and specialty chemicals, there are several areas where I’ve personally seen (and driven) tangible margin improvements simply by optimizing the chemistry itself.

Route Redesign to eliminate costly steps

One of the most effective ways to boost margins is by cutting down the number of synthetic steps and switching out costly reagents and catalysts for more affordable, atom-efficient options. Every step you can remove doesn’t just save on raw materials—it also reduces solvent use, labor, utilities, and cumulative yield losses throughout the process. In my experience, reworking even a couple of steps in a complex API synthesis has led to cost reductions of 15–20%, which is usually far more significant than what you get from installing a new reactor.

Solvent Selection and Recovery

Solvents are often the hidden culprit when it comes to eroding margins—whether it’s through direct costs, waste disposal, or meeting environmental regulations. By carefully selecting solvents that can be recovered more efficiently, or by moving to solvent systems that let you combine steps without isolating intermediates, you can make a real difference in both cost and sustainability. This is something that matters more and more to clients in regulated markets.

Yield and Impurity Control together

These two issues go hand in hand—if you don’t control impurities well, you often end up adding extra purification steps, more recrystallizations, or even sacrificing yield just to stay within specs. By designing reactions with impurity formation in mind from the start—especially genotoxic impurities under ICH M7—you can sidestep a lot of downstream costs that are much harder to fix later.

Debottlenecking through chemistry, not equipment

A lot of the time, what seems like a capacity bottleneck is really a chemistry problem—things like long reaction times, poor filtration, or tricky exotherm management that slow everything down. Addressing these issues at the process level can free up capacity using the equipment you already have, which is often a much smarter investment than spending on new infrastructure.

Non-infringing route design as a margin — not just legal strategy

This is something I think a lot of people overlook. Designing a non-infringing route isn’t just about steering clear of legal trouble—it often means you can use cheaper, more readily available starting materials and avoid costly licensing fees. That directly improves margins and can open up new markets at the same time.

 

Q3. In your experience, how much can a better synthetic route improve API economics, and where are companies still leaving cost savings on the table?

In my 22+ years of process R&D across APIs and advanced intermediates, a genuinely better synthetic route has repeatedly delivered 25–40% improvement in API economics, and even higher for some complex molecules. The gains come primarily from three levers: 

• Fewer chemical steps
• Higher overall yield
• Significantly lower raw-material and purification costs

For example, when we redesigned routes for several CDMO molecules destined for global MNCs, we routinely cut two to four steps, replaced expensive reagents with more accessible alternatives, and increased overall yields by 15–25 percentage points. Combined with solvent recovery and tighter impurity control, this translated into a 30%+ reduction in cost of goods while simultaneously increasing throughput in the same plant. A similar impact was seen earlier on molecules such as Galantamine Hydrobromide and Memantine Hydrochloride, where non-infringing, improved routes not only protected freedom to operate but made the processes far more commercially attractive.

Despite these proven results, I still see companies leaving considerable cost savings on the table in several recurring areas. 

Optimizing Synthetic Routes

Many teams remain anchored to literature or originator routes instead of investing early in creative retrosynthetic analysis and non-infringing alternatives. 

Impurity Control

Impurity fate mapping and genotoxic impurity control are often treated as regulatory checkboxes rather than cost drivers; incomplete understanding here forces expensive purification or reprocessing that erodes margins. 

Solvent Selection

Solvent selection and recovery systems are frequently under-optimized—especially at the pilot-to-commercial transition—driving high variable costs that could have been designed out. 

Process Intensification & Debottlenecking

Fourth, process intensification and debottlenecking are usually addressed only after problems appear in the plant, rather than being built into the route from the laboratory stage. 

Techno-Economic Evaluation

Finally, many organizations still under-invest in early-stage techno-economic evaluation, so they scale promising chemistry without a clear view of its ultimate cost structure.

In short, a superior synthetic route remains one of the highest-ROI interventions available in API manufacturing. The organizations that treat route design as a strategic, cross-functional exercise—linking chemistry, analytical science, engineering, and IP—regularly outperform those that treat it as a purely technical activity. That is where the real, sustainable cost advantage still lies.

 

Q4. Can you share examples from your experience where changing the synthetic route or process design materially improved the economics of an API, and what made that change successful?

One of the best examples I can share is from my work on an anti-Alzheimer’s molecule. The existing synthetic routes at the time were either tied up with patents or just too expensive to make sense at scale. By rethinking the process and developing a brand new synthetic route, we were able to file 2006/0009640A1—a method that was not only non-infringing but also much more commercially practical. The real key to this success wasn’t just smart chemistry; it was the close collaboration between the process chemistry and IP/legal teams right from the start. This way, every route decision considered both cost and freedom to operate at the same time, instead of optimizing the chemistry first and worrying about intellectual property later.

A second example is that we developed a route that could be synthesized from a pharmaceutical impurity stream, which was published as WO 2006/122238A1. This illustrates a wider principle I've applied throughout my career: sometimes the biggest economic win isn't in the main reaction sequence at all, but in finding value in what would otherwise be a waste stream or impurity. It reduced raw material dependency and turned what was a cost center into a more efficient input.

I worked on this for MNCs; the pattern that consistently drove successful route changes was similar: it required cross-functional buy-in early — production, quality, and regulatory teams engaged from the feasibility stage, not after a route was already locked. Technology transfer only succeeded smoothly when Gantt charts, MOC selection, and validation protocols were planned in parallel with the chemistry itself, rather than sequentially.

If I had to distill what made these changes successful across all these examples, it comes down to three things: 

• Designing with IP and economics in mind from day one rather than retrofitting later
• Involving cross-functional stakeholders beforehand rather than treating route change as purely a lab exercise
• Being willing to look at "waste" or impurity streams as potential value rather than just a compliance burden

That combination of technical discipline and organizational alignment is what consistently turned good chemistry into real, sustained economic impact.

Q5. If you could give one piece of advice to pharmaceutical industry leaders and investors looking at the Indian API/CDMO opportunity today, what would you tell them to focus on—and why?

If I had to give one piece of advice to sector leaders and investors evaluating the Indian API/CDMO opportunity today, it would be this: 

Invest in process chemistry depth and IP capability before you invest in capacity.

Prioritize capital deployment toward plants, reactors, and capacity expansion—because having the right capacity at the right time matters. But having spent 22+ years across several leading pharmaceutical and CDMO organizations, including time building an R&D function from scratch at a start-up, I can tell you that capacity without strong underlying process chemistry and IP strategy is a fragile foundation. It gets you volume, but not durable margin or defensibility.

The global clients I've worked with over the years—Top-50 pharmaceutical multinationals — consistently value something more specific than manufacturing scale. They value partners who can design non-infringing, cost-efficient routes from day one, understand genotoxic impurity control and ICH compliance deeply enough to avoid costly regulatory delays, and navigate technology transfer without losing time or yield. That combination protects margin and client relationships over the long term—not just having reactors available.