Value-Added Generics: Formulating Real-World Impact

By Dr. Mayur Sankalia, Senior Vice President – Formulation & Analytical R&D, Invengene Private Limited

Twenty years in formulation science has made me slightly suspicious of the word final. A final formulation, a final specification, a final stability report — these are necessary milestones in pharmaceutical development. They define what a product needs to achieve and give us the confidence to move forward. But they can also create a tendency to stop questioning once those requirements have been met.

Some of the most interesting work begins when we go back and ask whether those requirements still represent the best solution for the patient, the healthcare system and the environment in which the medicine will actually be used.

This is particularly relevant to generic medicines. Generics are often discussed primarily in terms of equivalence — delivering the same active pharmaceutical ingredient, strength, dosage form and therapeutic intent as an established product. That equivalence is fundamental, but the value of a medicine is not determined by the molecule alone. It is also shaped by how reliably it can be manufactured, transported, stored and administered, and by how easily it can reach the patients who need it.

That is where I believe the idea of value-added generics deserves a broader definition. A formulation can add value without changing the active pharmaceutical ingredient. It can do so by removing a practical barrier, improving stability, reducing waste, simplifying handling or making the product more resilient to the realities of healthcare delivery.

When Formulation Science Creates Real-World Value

One example from our work is Posaconazole. The formulation we were working with depended on an excipient system that required refrigerated storage. From a formulation-development standpoint, this was a scientifically sound and established approach. But when we considered the medicine’s journey beyond the laboratory, another question emerged: does it necessarily need to depend on a cold chain?

In the laboratory, refrigeration is simply a storage condition. In the real world, however, cold-chain dependence can make transportation and distribution more difficult, particularly in hot climates or markets where reliable refrigerated infrastructure cannot always be assumed.

We therefore explored an alternative excipient system and evaluated the formulation under challenging climatic conditions. The formulation has now demonstrated more than 24 months of stability at both 25°C/60% RH and 30°C/75% RH, with development continuing towards a targeted shelf life of 36 months.

The significance was not simply that we had developed a different formulation. More importantly, we had potentially removed a dependency that could make distribution more difficult. The molecule had not changed, but the practical environment in which the medicine could operate had. That experience reinforced an important lesson: formulation science can sometimes become a means of improving access.

A similar lesson came from a critical-care injectable used in cardiac settings. The original in-use stability after opening a vial was twelve hours. On a development report, that may look like nothing more than a number. But inside a hospital, it can have practical implications. Hospital pharmacies and clinical teams work within complex schedules, and a short in-use window can create constraints and contribute to avoidable wastage.

We re-engineered the preservative system and extended the in-use stability from twelve hours to seventy-two hours. Again, the value was not simply the increase in a stability number. A longer in-use window can give hospital pharmacies and clinical teams greater flexibility, reduce avoidable wastage and make medication management less constrained by a narrow preparation window.

The two examples are different, but they led us to the same fundamental question: Can formulation science remove a limitation that exists somewhere between the medicine and the patient? In one case, it was dependence on cold-chain infrastructure. In the other, it was a limited in-use window. Neither required changing the therapeutic molecule. Both required us to look beyond the formulation itself and consider how the medicine would function within the healthcare system.

Sustainability Is Part of the Formulation Conversation

These experiences have also reinforced for me that sustainability in pharmaceuticals cannot be considered separately from formulation and product design. A product that requires extensive cold-chain infrastructure has different resource requirements from one that can remain stable under ambient conditions. Similarly, a product with a short in-use window can create more wastage than one that remains usable for longer.

Patient safety and product quality must always remain the starting point. But once those fundamentals are established, we should also consider how the formulation interacts with the wider healthcare ecosystem and how efficiently a medicine continues to deliver value after it leaves the manufacturing facility.

Designing for the World Outside the Laboratory

Perhaps the biggest change in my thinking has been learning to look beyond the laboratory. Today, I ask what happens after a formulation leaves development: can it withstand transportation and different climates, does it depend on infrastructure that

may not always be available, and does it give healthcare professionals flexibility? These questions have made resilience an important part of formulation design.

Rethinking What Value-Added Means

This is why I believe the next generation of value-added generics needs to look beyond differentiation for its own sake. The more meaningful question is not simply what can we change? but what problem can we remove? Can we reduce dependence on cold-chain infrastructure? Can we make an existing medicine more stable in challenging conditions? Can we reduce unnecessary wastage? Can we simplify handling? Can we give healthcare professionals greater flexibility? Can we make the overall supply chain more resilient?

These questions may not always produce headline-making breakthroughs, but they can have a direct bearing on access, affordability, efficiency and sustainability.

At Invengene, this is increasingly how we approach formulation development. We see the role of R&D not simply as reproducing what already exists, but as asking whether there is a more practical, robust and responsible way of delivering the same therapeutic value. That means looking at the entire journey of a medicine — from manufacturing and distribution to storage, preparation and administration, and finally to the patient.

After two decades in this field, I have come to believe that some of the most meaningful innovation in generics happens quietly. It happens when a cold-chain dependency is removed, when wastage is reduced, when a formulation becomes more resilient, or when a healthcare professional gets a little more flexibility in how a medicine is used.

The molecule may remain the same. But the value delivered by the medicine can be very different.

Perhaps that is what value-added should really mean in generics: not novelty for its own sake, but thoughtful science that removes barriers between a medicine and the patient who needs it.

#ValueAddedGenerics #PharmaceuticalInnovation #FormulationDevelopment #cxolanes