India is very important for us, not just as a huge consumer market but also for production of the technologies. In 2016, we invested in Hyderabad facility. Later in 2021, we invested in very sustainable raw materials in Kashipur, having a joint venture with IGL, known as Clariant IGL Specialty Chemicals (CISC). We are now striving to leverage these platforms and do more in India

Kindly share details about the launch of eight new products at the CPHI event. How are these products going to make a difference to the Indian and export market?

Vaios Barlas: CPHI is certainly our first choice for launching such a product portfolio. We have offered eight new products out of which three belong to the group of VitiPure Superior grades, which means these are much purified grades in their parenteral applications. These are very sensitive applications for drugs or APIs that are really over sensitive and require minimum contaminants coming from the excipients side.

We are launching polyethylene glycol of LEX grade, which is likewise addressing the same space. Then we have Meglumine which is an alkaliser for acidic Active Pharma Ingredients (APIs). We also have hydrogenated Polyoxyl 35 Castor Oil for oral applications. It's a lubricant for sustained release agents and we have the newly launched Polyglykol 1450 S for topical and oral application.

Bhushan Thekedar: These ultra-pure products are manufactured under the brand name VitiPure Superior at our facility in Bonthapally, Hyderabad, India. Primarily intended for injection applications, these purified products include Polyoxyl 35 Castor Oil, designed specifically for chemotherapy injections, as well as VitiPure O 80 Superior (Polysorbate 80) and VitiPure L 20 Superior (Polysorbate 20). These products feature low residual impurities, minimal secondary oxidation impurities (such as peroxides and aldehydes), and low catalyst impurities.

They are meticulously crafted for parenteral applications, ensuring compatibility with sensitive APIs that cannot tolerate impurities in excipients. Additionally, we offer Meglumine, an alkalizer primarily used in diagnostic and oral applications, but also intended for injection use. All of these products are fully made in India, produced with our proprietary technology in clean room environments, ensuring the highest quality for high-end and sensitive applications.

We are incredibly proud of these products, not only for their benefit to Indian companies but also for the global pharmaceutical industry, which will greatly benefit from these locally manufactured solutions.

How big is the market for these products which you have launched at CPHI?

Vaios Barlas: These eight APIs are not just for the Indian market but for the global market. The global excipients market is huge and may soon reach about US $9 billion. India, of course is a very big market itself but we also know that it is producing about half of the world’s generics and has some leadership in domains like vaccines with 4% the global manufacturing. Our newly launched products address a big part of this market but what is important is that under the VitiPure Superior LEX grades, we address sensitive applications and offer more purified excipients. This is because we recognize the need of the industry for more purified excipients that will handle not only sensitive APIs, but also biologics coming on stream more and more where we really need extreme purity.

How are you leveraging the global expertise of Clariant with local manufacturing in Hyderabad? How are these synergizing your healthcare business?

Vaios Barlas: We are active globally although we have a facility in Hyderabad, India and we are producing here. We are leveraging our ecosystem as we have R&D and application labs in Germany, US, and China, and here in India which cooperate very closely to bring out the technologies that we are offering at present. It is a network of all our units across the globe to produce this. For example, a few of our polyglycols and other raw materials are produced in Europe and purified here. Therefore, all our units work together to give this final end result.

How do you look at India with respect to new molecules or new products and also from an overall scheme of Clariant healthcare business?

Vaios Barlas: India is very important for us, not just as a huge consumer market but also for production of the technologies. In 2016, we invested in Hyderabad where we have a facility. Later in 2021, we invested in very sustainable raw materials in Kashipur, having a joint venture with IGL, known as Clariant IGL Specialty Chemicals (CISC). We are now striving to leverage these platforms and do more in India which is not just a very dynamic and vibrant consumer market but has a technological edge. Hyderabad is really a pharma hub and we are very happy to see that we can find the right people with the right knowledge to work for us and do the R&D for the next generation of technology or do their process technology required to produce them at the right level of purity.

Do your products meet the global standards of whether USFDA and European EMA and other regulatory bodies for export, and also to be produced and supplied in the Indian market?

Vaios Barlas: This is exactly our target and this is what we are doing today. Our products are designed for export and fully comply with major pharmacopeias, including Ph. Eur, USP, JP, and, in some cases, ChP. They are also approved by regulatory bodies such as the USFDA and EMA, ensuring they meet global standards.

When you say that you are offering more purified excipients to the market, how does it help the pharmaceutical companies?

Bhushan Thekedar: Currently, there are very few suppliers capable of providing purified excipients to pharmaceutical companies—perhaps just one or two. As a result, pharmaceutical companies are heavily reliant on these limited suppliers, creating ongoing supply chain challenges, high prices, and significant duties. There is a pressing need for a second, third, or even more reliable suppliers who can offer competence and stability in this market. This is where Clariant comes in. With years of expertise in manufacturing ultra-pure excipients, we are able to meet the exact needs of pharmaceutical companies. In the coming months and years, we will continue to expand our range of purified excipients, offering pharmaceutical companies a dependable partner. This is the kind of reliability that will truly benefit the industry and satisfy the growing demand for a trustworthy supplier like Clariant.

Vaios Barlas: There are very few players, and their offering is very narrow. We are striving to set the bar higher, making our specifications even narrower and stricter than what we have today from other excipients suppliers. Therefore, we are trying to gain leadership in quality, offering as high quality as possible.

With new molecules coming up based on API, what kind of solutions are you planning to offer pharmaceutical companies?

Bhushan Thekedar: These excipients are primarily intended for parenteral applications, both for small and large molecules. They are specifically designed for the most stringent specifications, offering ultra-purity. The VitiPure Superior and Meglumine grades are ideal for applications that require the cleanest excipients, such as monoclonal antibodies, recombinant proteins, and vaccines. These excipients are tailored for highly sensitive applications, ensuring the highest level of quality for both small and large molecule formulations.

Are you manufacturing the complete range of excipients and APIs in India or there is still a lot more to do moving forward?

Vaios Barlas: As I explained before, we are leveraging several sites, both global and in India, depending on their specific competencies. India remains a very important part of our ecosystem, but we leverage it on all our sites. Today we produce in China near Hongkong, Germany and here in Hyderabad and Kashipur, and very soon in Texas. We have combined the capabilities of all our sites to bring the best products to the market.

What are the new product ranges that you are planning to come with VitiPure Superior and Meglumine?

Vaios Barlas: Just not to over promise, I am being a little bit conservative. To give you an idea of where we are heading, we are covering the standards with three different levels of purity. We want to build our product offering and output for VitiPure Superior and Meglumine with highest purity. So you will see a much broader portfolio of the range in the years to come. 

How do you look at the global pharma market for the next year, both from a global as well as Indian perspective?

Vaios Barlas: Globally, the trends for pharma and healthcare are more towards training and building personal capacities besides growing need for immunotherapies and the capability of the industry to provide those. We see mRNA triggered drugs were delivered for the first time, to a broad extent with a covid vaccine wave. It has shown the capabilities of these technologies in gaining the trust of the global society. We see gene therapies and cell therapies and biologics playing a bigger and bigger role in this direction. The obesity reducing drugs are again in the trends and with all these solutions in the API world require more and more sophisticated drug delivery systems. This is where we want to play because for many years APIs, either in the small molecule or large molecule range, gave a lot of solutions in the laboratory but we could not really find the right vehicles to make them really functional in the human body. That required efficient drug delivery systems. We are working on it and India is a key player in developing and producing drug delivery systems.

Bhushan Thekedar: We have participated in CPHI as exhibitors, showcasing our strength in excipients and products to customers in India. Our aim is to offer locally produced, Made in India products that are supplied globally. I’m confident our customers in India will be thrilled to see products manufactured locally, right next door. We are committed to supporting them 24/7.