Sun Pharma USA: Making a Mark with Complex Technology, Differentiated Products

We began our US foray in 1997, when we first took a stake in Caraco, which then had sales of less than $1 million and a few approvals. Since then, we’ve built up a substantial business in the US, and now it contributes to more than half of our business. Last year’s consolidated US revenues were over $1 billion, 54% of revenues, spurred partly by sales of unapproved Lipodox (Liposomal Doxorubicin nanoparticle injection), which we were allowed to sell with special permission in order to meet a Doxil® shortage.

Sun Pharma USA offers a range of high-quality generics across dosage forms, with strong portfolios in controlled substances: anticancers. Recently, we acquired URL Pharma (except for the Colcrys business) to strengthen our product basket. The acquisition of DUSA with its patented business (Levulan® and Blue-light device) allows us to initiate a presence in the dermatology device market.

We believe the $70 billion US generic market offers us a tremendous opportunity to bring to the patient high-quality pharmaceuticals made to exacting standards in FDA-approved plants both in the US and in India.

Starting with simple dosage forms, tablets, and capsules, our range has now grown to encompass differentiated products such as nanoparticle-based injections for targeted drug delivery, lyophilized injections, auto-injections, and controlled release products.

We’re one of the few generics companies that have manufacturing both in the US and India. Starting with 1 Indian and 1 US mainland FDA-approved plant each in 1997, we now have 6 dosage form plants in the US, in addition to 3 plants in India that are USFDA approved. Our Cranbury plant is designed to make controlled substance formulations. For API, we have 3 approved plants in India, in addition to a plant each in the US (Chattem Chemicals) and Hungary.

These plants are designed, built, and run to stringent FDA requirements. Our ability to develop processes and make in-house API for complex products such as peptides, controlled substances, and hormones ensures that we not only use the best quality API but are also among the most efficient producers.

An experienced and skilled regulatory team ensures dossiers are comprehensive and good quality. Corporate quality teams support technically proficient teams at each of the plants; an independent corporate compliance team ensures that all our factories and those of our vendors and suppliers meet FDA norms.

We have over 350 ANDAs approved, and over 138 await approval, with filings for complex products such as nasal sprays, depot injections, and modified-release products. This is one of the strongest pipelines among Indian companies. Every year, we file around 20+ ANDAs to replenish our pipeline.

Across 4 world-class research centers, over 800 scientists work on process and product development so that we’re able to continually file for ANDA and API and move up the scale in terms of complexity.

A strong patent team works with our scientists to examine possibilities for non-infringing processes or science-based patent challenges.

With clear plans for growth, we’re keen to grow our US presence and bring the customer high-quality generics that can be trusted.

For more information, please visit www.sunpharma.com.