In 1984, Dr. Kallam Anji Reddy left a secure career at a state-owned company, invested his savings, and started a pharmaceutical business in Hyderabad with a single drug: methyldopa, for high blood pressure. He believed Indian chemists could manufacture active pharmaceutical ingredients to international standards. Forty years later, his company operates in seventy-four countries and manufactures over four hundred generic drugs — including some of the most complex injectables and biosimilars on the global market.
Anji Reddy was not a businessman who hired chemists; he was a chemist who became a businessman. He had spent seventeen years at Indian Drugs and Pharmaceuticals Limited, the government’s bulk drug manufacturer, mastering the synthesis of active pharmaceutical ingredients. When he founded Dr. Reddy’s Laboratories in 1984, he brought with him a conviction that India had the scientific talent to produce APIs not just for its own market but for the world.
The early years were an exercise in building credibility. Dr. Reddy’s began by exporting methyldopa and ibuprofen as bulk APIs — selling the raw ingredients to foreign formulators who turned them into tablets and capsules. This was the humblest rung of the pharmaceutical value chain, but it forced the company to meet international quality standards from day one. A batch rejected by a European buyer meant not just lost revenue but lost reputation. There was no room for inconsistency.
By the late 1980s, Dr. Reddy’s was exporting APIs to Europe and had begun preparing for the market that would define its trajectory: the United States.
The US pharmaceutical market is the most regulated and most lucrative on earth. To sell a generic drug there, a company must file an Abbreviated New Drug Application — an ANDA — demonstrating that its product is bioequivalent to the branded original and that its manufacturing facility meets FDA standards. In the early 1990s, very few Indian companies had attempted this. Dr. Reddy’s was among the first.
In 1987, the company gained its first US approval for ibuprofen API. In 2001, it went further — listing on the New York Stock Exchange, the first Indian pharmaceutical company to do so. The NYSE listing was more than a fundraising event; it was a signal. It said that an Indian drug company was willing to submit itself to US capital-market scrutiny, with all the transparency and governance requirements that entailed.
The US business grew steadily through the 2000s, driven by a pipeline of ANDA filings. By FY14, North America contributed 42% of total revenue and had crossed the $1 billion mark. The company’s approach was distinctive: rather than competing on volume in crowded generic categories, it targeted complex products — injectables, peptide drugs, controlled-substance generics — where the manufacturing barriers kept most competitors out.
The structural challenge facing every generic company is the same one Sun Pharma confronted: how to grow when your business model is defined by selling things cheaply. Dr. Reddy’s answered the question differently. Instead of pivoting to branded specialty medicines, it moved up the complexity curve within generics itself — and it bet early on biosimilars.
In 2007, Dr. Reddy’s launched Reditux, a biosimilar of Roche’s rituximab, for non-Hodgkin’s lymphoma and rheumatoid arthritis in India. It was among the earliest biosimilar launches anywhere in the world — years before the regulatory pathway for biosimilars existed in the United States. The company followed with biosimilar pegfilgrastim and began developing a pipeline of complex biologics for global markets.
Alongside biosimilars, the company deepened its complex generics capability. In FY22, it launched the generic version of lenalidomide, a $12 billion oncology drug in the United States — a product that required not just chemistry but the navigation of a restricted distribution system and multiple patents. In FY23, Dr. Reddy’s North American generics business crossed $1 billion for the first time, and its Indian branded generics business reached the same milestone independently. The company had become a multi-billion-dollar enterprise with two distinct billion-dollar pillars.
Dr. Reddy’s operates across seventy-four countries with a workforce of forty-eight nationalities. North America has historically contributed the largest share of revenue, but the geographic balance has shifted: in FY23, the company’s Indian and emerging-markets branded business each crossed the billion-dollar mark, creating a more resilient three-pillar structure. In Europe, the company operates across multiple countries with thirty-five new product launches in FY23 alone. In emerging markets spanning Russia, CIS countries, Romania, and the rest of the world, it generated strong growth through branded generics.
Dr. Reddy’s manufacturing footprint is concentrated in Telangana and Andhra Pradesh — Hyderabad’s pharmaceutical corridor. Twelve facilities in India carry US FDA registration, spanning API synthesis in Sangareddy and Nalgonda, formulation and packaging in Srikakulam and Visakhapatnam, and analytical operations in Medchal-Malkajgiri. The geographic concentration is deliberate: proximity to Hyderabad’s deep pool of pharmaceutical scientists creates a recruitment advantage that dispersed manufacturing cannot replicate.
The company’s regulatory record reflects both ambition and hard-won discipline. In FY17, three manufacturing facilities received USFDA warning letters — a setback that cost the company product approvals and revenue growth for nearly two years. Dr. Reddy’s invested heavily in remediation, overhauled quality systems, and resolved the warnings. The experience reinforced a principle that every global manufacturer eventually learns: in pharmaceuticals, quality is not a cost centre but the foundation of market access.
Sources: Dr. Reddy’s Annual Reports FY2014 through FY2023. US FDA facility registration data. Indian patent office records.