Headquarters: Mumbai, India
2016 generic revenue: $3.61 billion (estimate)
India’s Sun Pharmaceutical has had its ambitions stymied by FDA action against a key manufacturing plant, but it still managed to generate more than $3.6 billion in generic sales during its last fiscal year.
That figure excludes sales of its U.S.-based Taro Pharma subsidiary, in which Sun holds a 69% controlling interest. Taro in its last fiscal year reported $950 million. But even if its share of the Taro sales were figured in, the drugmaker would fall a little short of making the top five, a ranking it still claims to hold in the U.S.
Many expected to see the company further along at this point, two years after its buyout of Indian peer Ranbaxy Laboratories, but things just have not worked out as Sun founder and Managing Director Dilip Shanghvi envisioned when he completed that deal. Ranbaxy came on the market because of its own regulatory problems.
The deal doubled Sun Pharma’s size and definitively made it India’s largest drugmaker. At that time, Shanghvi pledged to resolve FDA concerns for the four Ranbaxy plants the FDA had banned from selling in the U.S. and told investors growth should unfold as each plant came back online.
But instead of achieving much with Ranbaxy, Sun got sidetracked when the FDA issued a Form 483 in 2014 and then a warning letter in 2015 for its Halol, India, API plant, a facility crucial to supplying the generic meds it sold in the U.S. Those regulatory setbacks kept it from winning any new generic drug approvals from the facility, hurting Sun’s growth.
Even as the problems at Halol have stunted Sun’s generic growth plans, however, the company has found ways to bring some important products to market. Last year, its U.S. sales were boosted significantly by its 6-month, first-to-file exclusivity for its copy of the Novartis leukemia treatment Gleevec.
While Shanghvi continues to believe in the potential for growth in generics, it also has branched into drug development and bought some branded meds to help it move further up the pharma food chain.
One deal involved buying 14 older but established prescription brands from Novartis in Japan for $293 million. The acquisition gave Sun solid footing in the country even as Japan’s government turns to more generic meds to cut its healthcare bill for an aging population. But then, that was the same strategy Ranbaxy’s former owner, Daiichi Sankyo, had undertaken before the unit's regulatory problems led the Japanese drugmaker to give up and sell it off to Sun.
Sun's fiscal year ended on March 31, 2017.