Bikramjit Ghosh

VP - Strategy & Business Development

While the Indian pharma sector caters to a large variety of healthcare areas, one that is witnessing a lot of traction lately is oncology. Of late, we are witnessing a significant rise in the number of cancer cases countrywide majorly due to unhealthy food intake, sedentary lifestyles, environmental pollution and increased tobacco consumption. According to recent estimates, global spending on cancer medicine increased to $223 billion in 2023, $25 billion more than 2022, and is projected to reach $409 billion by 2028, with an expected CAGR of over 11 percent.

Emerging as the true lifesavers and helping the country successfully overcome the cancer crisis are the multitude of oncology drug manufacturers currently operating in India. Among them, one company that truly stands out is Sakar Healthcare. Based in Ahmedabad, Sakar Healthcare was established in 2004 by Sanjay Shah, Founder & MD, with a vision to make the lives healthy, happy and more meaningful for the patients by providing world-class healthcare solutions.

State-of-the-Art Oncology Unit

As one of the leading pharmaceutical manufacturer in Western India with proven excellence in providing innovative oncology solutions, Sakar Healthcare boasts of having a research-driven API-integrated EU GMP approved oncology formulation manufacturing unit. With all cuttingedge technologies in place, the R&D lab not helps the company to streamline the entire process and also ensure highest drug development standards, from concept to final product development. Sakar Healthcare has been granted with a Patent for Imatinib for preparation using Vilsmeier reagent and is presently developing patent non-infringing oncology products for partners originating from Greece, Switzerland and India.

With a production capacity of 55 million tablets and 29 million capsules annually in single shift, Sakar Healthcare's EU GMP approved oral solid dosage manufacturing unit is integrated with some of the best-in-class automation machinery such as the advanced fully containment equipment from GEA (Belgium). The injectables production unit comprises of isolators that facilitates per shift production of 13 million 10ml vials and sophisticated two lyophilisers with automatic vial loading and unloading system, that can manufacture up to 30,000 10ml lyophilized vials per cycle.

Oncology API Integration – The Key Advantage

Sakar Healthcare's API manufacturing plant is equipped with glass-line reactors and automated systems to handle cytotoxic products at various scales, with a production capacity of around 10 tons per annum. As a feather to its crown, the API production facility has successfully developed 21 APIs so far, of which 10 have written confirmation, 19 are with DMF and seven being prepared for CEP. “Being integrated with oncology API not only helps Sakar Healthcare easy access to the API, but also facilitates easy commercialization of the drug in the quickest timeframe possible”, comments Aarsh Shah, Joint Managing Director, Sakar Healthcare.

“The process of submission of eCTD dossiers for marketing authorizations/registrations of 36 identified anticancer molecules is ongoing in the EU and other emerging markets. The bioequivalence studies for the OSD has been carriedout through FDA/EU approved CROs using RLD procured from EU regions, while we also conduct tests like extractability-leachability and bacterial endotoxin along with filter & sterility validation of sterile injections. With our flexible business models including co-development, partnering technology-transfer, scale-up developed products, outlicensing, CDMO to companies globally, Sakar Healthcare stands as one-stop solution for partnerships and collaborations with product band-width”, says Bikramjit Ghosh, VP - Strategy & Business Development, Sakar Healthcare. Sakar Healthcare is now spreading the wings with these ready set of oncology products that covers keys markets of the European Union, South & Central America, MENA and Asia.

Journey So Far & Future Roadmap

With a strong presence across four continents, manufacturing and exporting oral liquids, antibiotics (oral solids), antibiotics (DPI) and small volume parenteral (liquid/ lyophilized injections in vials and ampoules) covering 24+ therapeutic segments, Sakar Healthcare has registered multiple milestones. Now both the manufacturing plants hold regulatory approvals including EUGMP. Sakar Healthcare has been a preferred partner under CDMO for global players including Zydus, Ferring, Torrent, Baxter, Intas, Merck, Glenmark, and Emcure.

“Our long-term mission and objective is to strengthen our core competencies and become the preferred choice in pharma manufacturing market, especially with oncology range of products. Going forward, the company plans to explore new market opportunities and expand its range of differentiated products introducing value-added affordable products with liposomal, nano-particle, hot-melt extrusion technology, simultaneously staying compliant to all necessary regulations, protecting the environment, and benefitting mankind”, says Sanjay Shah, Founder & Managing Director, Sakar Healthcare.