Zydus Lifesciences, headquartered in Ahmedabad, is one of a handful of Indian pharmaceutical companies to have discovered, developed, and commercialised genuinely new chemical entities. Its drug Saroglitazar — marketed as Lipaglyn — was the world’s first dual PPAR agonist, approved in India for diabetic dyslipidemia. The same company also ranks fifth in the United States by generic prescriptions. That combination of discovery and scale is rare anywhere in the world.
India’s pharmaceutical industry was built on reverse engineering — taking molecules invented elsewhere and manufacturing them cheaper and at scale. Zydus decided to play both games. While running one of the largest generic pharmaceutical operations in the country, it simultaneously invested in new chemical entity discovery, an endeavour that carries the kind of risk that most Indian companies would rather leave to the multinational labs in New Jersey and Basel.
The breakthrough was Saroglitazar, a first-in-class dual PPAR alpha/gamma agonist for diabetic dyslipidemia, approved in India in 2013 and marketed as Lipaglyn. It was the first new chemical entity to be developed entirely in India by an Indian pharmaceutical company. Desidustat (marketed as Oxemia) followed — an oral HIF-PHI for anaemia in chronic kidney disease patients. Usnoflast (ZYIL1), an oral mast-cell stabiliser for chronic urticaria and allergic rhinitis, represents the third generation of Zydus’s NCE pipeline.
Three novel molecules, each addressing conditions where existing treatments are inadequate, from a company that also fills hundreds of millions of generic prescriptions a year. This is the Zydus paradox: it operates simultaneously at the commodity end and the frontier end of the pharmaceutical industry.
The generics business is what funds the innovation. In the United States, Zydus ranks fifth among all generic pharmaceutical companies by prescriptions filled — a position that places it alongside Teva, Viatris, Sandoz, and Hikma in one of the most competitive markets on earth. The company ranks in the top three for approximately 60% of its US product families, a dominance that reflects decades of ANDA filing discipline and manufacturing scale.
In India, Zydus holds seven brands among the country’s top 300 pharmaceutical products, with approximately 50% of domestic revenue coming from branded business. The branded and generic businesses are not separate divisions in different buildings — they are two expressions of the same R&D and manufacturing infrastructure, running on shared regulatory systems and quality standards. Revenue grew 19% year-over-year in FY 2025 to $2.77 billion, with EBITDA margins of 30.4% and net profit growth of 23%.
Zydus’s capabilities extend beyond small-molecule generics and NCEs into biologicals, biosimilars, and vaccines. During the COVID-19 pandemic, Zydus developed ZyCoV-D, the world’s first plasmid DNA vaccine for COVID-19, approved for emergency use in India. The vaccine represented a new platform technology — needle-free intradermal delivery — that has applications beyond the pandemic.
The biologicals portfolio includes biosimilar monoclonal antibodies, insulin analogues, and recombinant proteins. This breadth — small molecules, biologics, vaccines, and NCEs — from a single Indian company with 96 operational units and 27,000 employees gives Zydus a platform diversity that few global pharmaceutical companies can match, let alone Indian ones.
Zydus operates 96 operational units globally with 37 manufacturing facilities, primarily in India. The company’s 18 US FDA-registered facilities represent one of the densest FDA footprints of any Indian pharmaceutical company. In the US, the company ranks fifth by generic prescriptions and in the top three in 60% of its product families. India and emerging markets contribute the branded half of the business, while the US drives the generics volume.
Sources: Zydus Lifesciences Integrated Annual Reports FY2023–24 and FY2024–25. US FDA facility registration data. Indian patent office records.