In May, Lupin announced the com- pletion 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 expan-
sion in capacity at the Somerset site and
was part of a plan to meet the demand for
affordable medicine in the U.S.,” said Vi-
nita 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.”
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
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 work-force 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 Mat-suk, 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. CP
S. Harachand is a pharmaceutical journalist
based in Mumbai. He can be reached at
Top Indian Firms Expand Base
in the U.S.
Goal is to make more drug products in America