In this exclusive interview with Liza Laws for Discover Pharma, Dr. Abdelaziz Toumi, CEO of Lupin Manufacturing Solutions (LMS), reflects on India’s structural CDMO potential, the market gap LMS is positioned to fill, and what credible success in pharmaceutical manufacturing actually requires in terms of capability, culture, and talent.

He strongly believes India has an opportunity to expand its share of the global CDMO market, but success will depend on scientific capability, regulatory expertise and investment in complex manufacturing. Throughout this interview he explains more.

LL: India currently holds a small share of the global CDMO market. What needs to change structurally for that to shift? 

AT:  India’s CDMO story has been predominantly a generics story — high-volume, cost-competitive, built around established molecules. That heritage is genuinely valuable, but it has also created a structural gap. The global CDMO opportunity being contested right now is fundamentally about scientific capability, not cost arbitrage, and India has historically under-invested in the infrastructure that capability-based competition demands.

Three things need to change. First, a deeper investment in process chemistry talent who cannot only execute synthesis, but people who can design and troubleshoot it at commercial scale. Second, a genuine willingness among Indian manufacturers to take development-stage risk, rather than waiting for fully resolved processes at the technology transfer gate. Third, a regulatory sophistication that keeps pace with the expectations of topmost global regulatory authorities including USFDA, EMA and PMDA for complex, novel modalities.

The narrative is beginning to shift. However, shifting a market position of this structural depth takes deliberate investment over a sustained period.

LL: Lupin Manufacturing Solutions is still a relatively new CDMO platform. What gap in the market are you trying to fill that others are not addressing?

 AT:  The gap is not in capacity — the industry has accumulated considerable manufacturing capacity over the last decade. What is genuinely underserved is capability at the intersection of complexity and continuity: the ability to take a scientifically demanding molecule through development and into commercial supply without a handover event that resets the risk clock.

Most CDMOs are strong within a defined stage or modality. Where we see a consistent structural gap — and where LMS is deliberately positioning — is the integration of complex small molecule development, peptide manufacturing infrastructure, and high-potency API capability within a single regulatory envelope and quality system. Sponsors working on the hardest programs do not want three best-in-class vendors with three separate tech transfer events. They want a partner who carries the molecule across the full lifecycle.

We are building exactly that. Our recent investments in an integrated CDMO block along with dedicated peptide infrastructure at Dabhasa and a state-of-art recently commissioned HPAPI facility at Visakhapatnam are the physical expression of that thesis.

LL: How are you balancing being part of a large parent company with the need to operate as a nimble CDMO partner? 

AT:  This is one of the questions I think about carefully, because the tension is real — and pretending otherwise would be dishonest. Large pharmaceutical organizations have governance cadences, decision hierarchies, and quality systems designed for scale and risk management. A CDMO competing for development-stage programs needs to move with a different rhythm.

What we have worked hard to establish is a clear separation between the advantages we draw from Lupin’s infrastructure — regulatory track record, quality system maturity, financial stability, and a deep pool of scientific talent — and the operational decisions that need to remain ours. Sourcing decisions, program prioritization, customer response timelines — these cannot be routed through a large-company approval matrix and still meet sponsor expectations.

The honest answer is that the parent relationship is an asset for credibility and a discipline for quality and at the same time — the job of LMS leadership is to make sure it never becomes a constraint on responsiveness.

LL: To what extent are customers actively diversifying away from China, and how real is that opportunity for LMS? 

AT:  The demand is real. What I would caution against, though, is framing this purely as a geopolitical trend — because that framing can mislead suppliers into thinking, the opportunity is passive. Customers are not simply looking to replace Chinese CDMOs with non-Chinese equivalents. They are looking to rebuild supply relationships with organizations that have demonstrable regulatory credibility, technical depth, and the manufacturing infrastructure to sustain long-term programs.

That raises the bar considerably. The question Indian CDMOs — including Lupin Manufacturing Solutions — need to answer is not “are you geographically acceptable?” but “can you technically match or exceed what we were getting, at a quality standard we can defend to our regulatory agencies?”

That distinction matters. Companies treating this as a marketing opportunity rather than a capability challenge will find the window closes quickly. Sponsors are sophisticated — they conduct rigorous technical audits before they commit. The opportunity is genuine. The work to earn it is equally real.

LL: In a CDMO relationship, trust is everything. What does “quality” mean in practice for LMS? 

AT:  Quality in pharmaceutical manufacturing is frequently conflated with regulatory compliance — and compliance matters, obviously. However, quality as a practice is something different, and the distinction is not semantic. Regulatory compliance describes the floor. Quality culture describes how an organization behaves in the space between audits, in the ordinary decisions that accumulate into a manufacturing track record over years.

For Lupin Manufacturing Solutions, quality in practice means two things. First, scientific honesty — the willingness to stop a process or raise a concern before it becomes a deviation. That requires a cultural environment where technical staff feel genuinely empowered to surface problems early, which is considerably harder to build than any quality system on paper. Second, rigorous process understanding — knowing not just that a synthesis step works, but mechanistically why it works, what the sensitivity thresholds are, and where the failure modes begin.

Quality built on those foundations is what sponsors can actually rely on under pressure.

LL: What are clients asking for today that they were not two years ago — and how are you prioritizing which technologies or modalities to invest in? 

AT:  Two shifts stand out clearly. The first is supply chain transparency. Clients two years ago were asking — “can you supply this?” Today they are asking — “show us every tier of your supply chain, with contingency plans for each critical node.” That is a structurally different conversation requiring different operational infrastructure.

The second is earlier engagement. Sponsors are now approaching CDMOartners at Phase I or even pre-IND, wanting the manufacturing voice in the room during process design decisions instead of waiting at the technology transfer gate. That shift reflects the accumulated cost of resolving late-stage manufacturing problems that could have been designed out earlier.

Our investment prioritization reflects that we follow the science, not the market cycle. Peptide building blocks and HPAPI are where we are concentrating capital because the technical barriers are highest, the sponsor demand is structural rather than cyclical, and the capability genuinely takes years to build properly — which creates defensible positions for those who arrive first.

LL: How is AI or digitalization actually changing manufacturing on the ground, beyond buzzwords? 

AT:  The honest answer — selectively and unevenly. The organizations making real progress are those that resisted deploying AI broadly and instead identified specific problems where data quality and process complexity align to create genuine value.

In CDMO context, the most meaningful applications are in process analytical technology — using real-time in-process data to detect and diagnose batch behavior before a drift becomes a deviation. The value here is not marginal; it materially changes the economics and timeline of batch release. The second area is predictive maintenance — moving equipment management from scheduled intervention to condition-based response. Neither is glamorous. Both deliver measurable results.

What I find myself saying to the team regularly is that the quality of the digital outcome is entirely dependent on the quality of the underlying data architecture. The technology is largely available; building the data infrastructure and the analytical competency to use it well — that is the real work, and it is not fast.

LL: What does success look like for Lupin Manufacturing Solutions over the next 3-5 years in concrete terms – capacity, customers, or revenue mix?

AT:  I am deliberately cautious about defining success primarily in capacity or revenue terms — not because those numbers do not matter, but because organizations that anchor strategy to scale targets tend to make investment decisions that serve metrics rather than the underlying science. The CDMOs that grew most credibly over the past decade did so because they built the right things, not because they optimized for headline numbers.

For Lupin Manufacturing Solutions, success over the next three to five years looks like three things concretely. First, completing the build-out at Dabhasa and Visakhapatnam to full operational maturity — not just commissioned, but genuinely running complex programs at global quality standards. Second, establishing LMS in the active vendor lists of innovation-driven sponsors in peptides and HPAPI — the kinds of programs that require a genuine development partner. Third, building the scientific talent pipeline that sustains this capability beyond the current investment cycle.

Revenue follows that. It does not precede it.