In May, Lupin announced the completion of expansion activities at its Somerset manufacturing facility. The Mumbai-based generic maker is planning to increase production to as much as 4.5 billion units out of the 150,000-square-foot factory by the end of next fiscal year. Currently, the plant makes about 3.5 billion units of various drug categories.  

For the expansion, Lupin spent $20 million upgrading the Somerset facility. The company acquired the factory from Gavis Pharmaceuticals for $880 million in 2015 as part of its strategy to set up a manufacturing base in the U.S. In addition to the 45,000-square-foot manufacturing facility, the Gavis purchase provided Lupin with another 124,000 square-foot packaging and distribution wing. It is expanding the distribution operations at the Somerset site as well by adding another 40,000 square-feet of space.

The Gavis deal helped Lupin to get into controlled substances and dermatology segments, which the New Jersey-based niche generic firm specializes in. At present, the Lupin plus Gavis portfolio comprises over hundred products. With several approvals pending, the company is targeting to launch more than two-dozen products every year in the U.S. market.  

“This expansion was a tenfold expansion in capacity at the Somerset site and was part of a plan to meet the demand for affordable medicine in the U.S.,” said Vinita Gupta, chief executive officer, Lupin. “The need for affordable medicines to all in the U.S. is steadily increasing and Lupin is very committed to meet the need.”

Deeper presence
Lupin is one among those Indian generic majors striving to have a deeper presence in the U.S. even as the debate over drug pricing is catching fire in the world’s largest marketplace under President Trump. In line with Lupin, these firms cherish the view that the need for affordable medicines is getting bigger and bigger by the day for patients, government and other stakeholders in the North American country.

With a record number of ANDAs and DMFs, pharma firms from India play a prominent role in the U.S. generic space today. Indian biopharma companies also hold forth that biosimilars with similar levels of quality, safety and efficacy of the transformational innovator products, can provide an affordable alternative therapy for both patients and payers.

Clearly, the Indian generic players discern the preference for cost-effective therapies will continue to rise in the U.S. market. At the same time, they also see the possibility that the new regime is favoring made-in-America drugs. This may, partly, explain expansion activities, of late.

In recent years, several Indian companies have been successful in establishing their own manufacturing bases U.S. soil. According to the Indian Pharmaceutical Alliance, an industry grouping of large Indian firms, its member companies have invested nearly $9 billion while employing over 4,000 people in the U.S. over the past six years.

Hiring locally
Glenmark Pharmaceuticals, another generic firm headquartered in Mumbai, is now on a hiring spree to man its manufacturing facility at Monroe. Glenmark is planning to enhance the local workforce by 45% as part of expanding the 102,000-square-foot factory in the Monroe Corporate Center, which the company started building in 2014.

Post-expansion, the plant will be able to churn out 300-400 million capsules and 20-25 million vials and pre-filled syringes. To broaden the manufacturing capacities further, Glenmark is in the process of purchasing another five acres of land near the 15-acre Monroe campus.

The company says it will manufacture more in the U.S., according to Robert Matsuk, president, North America and global API business of Glenmark. The company’s U.S. sales grew over 50%. 
Glenmark expects to bolster North American operations as the company gets into differentiated product lines including complex generics and drug-device combos. Glenmark is also seeking approval from the FDA to manufacture commercial batches of controlled substances. The company recently obtained clearance from the Drug Enforcement Administration (DEA) to manufacture Schedule II drugs.

Reports indicate that Aurobindo Pharma is looking to establish its second U.S. facility for local manufacturing. The Hyderabad-based company began construction on its injectables factory at the 90-acre campus on Windsor Center Drive in New Jersey late last year.

Meanwhile, others, including Cipla, which bought out generic manufacturers InvaGen and Exelan for $550 million in February 2016, are keeping a close watch as the scenario unfolds.