Corrections or additions?
These articles by Barbara Fox by Peter Mladineo were published in U.S. 1 Newspaper on
May 13, 1998. All rights reserved.
Generic Drugs: Ranbaxy
Everybody knows about the big pharmaceutical companies
that dot New Jersey’s corporate landscape. We are all familiar with
how their research contributes to the financial health of the state
and the physical health of the nation. Drug firms here produce 43
percent of the nation’s prescription drugs and contribute more than
$8 billion to the state economy.
What few stop to consider are the number of firms that manufacture
drugs that are identical to but cheaper than those pioneered by the
major firms. Generic drug makers are indeed important to New Jersey’s
economy, and Princeton has just acquired another one. The United
office of a publicly traded India-based company has moved to Princeton
from Raleigh, North Carolina. Last year Ranbaxy Pharmaceuticals Inc.
bought North Brunswick-based Ohm Laboratories and now is settling
into its new regional headquarters at 600 College Road.
Ranbaxy joins neighboring private-label manufacturers such as
a Bristol-Myers Squibb generic manufacturer on Scudders Mill Road;
Guardian Drug, a 13-year-old firm which makes stomach remedies on
Prince Street in Trenton; Xechem, which researches and produces
and generic drugs on Jersey Avenue in New Brunswick; and Neil
located at 55 Lake Drive in Hightstown.
Dipak Chattaraj is regional director of the worldwide company, Ranbaxy
Laboratories Ltd., based in New Delhi and publicly traded in India
and Luxembourg. He is president of Ranbaxy Pharmaceuticals Inc., a
wholly owned subsidiary. Incorporated in Delaware, it started out
in North Carolina in 1994. Together with Ohm Laboratories, Ranbaxy
has more than 140 employees.
Ranbaxy makes both over-the-counter and ethical (prescription drug)
generic products for all of the various components of the United
healthcare market, from supermarket drugstores to managed care
About 40 percent of Ranbaxy’s ethical drugs are made in India, but
the rest are made here. Its ethical drugs will be in these therapeutic
areas: antiinfectives, analgesics, nonsteroid anti-inflammatories,
cardio vascular agents, anti-allergenics, and gastrointestinal.
At Ohm Laboratories Ranbaxy manufactures private label brands of
products primarily for the United States market. It specializes in
analgesics, gastrointestinal medicine, and cough and cold
Arun Heble, founder of Ohm Laboratories, was a
major at the University of Kansas, Class of 1967. He went directly
into pharmaceutical manufacturing, started the firm on Black Horse
Lane in 1982, and sold it to Ranbaxy Pharmaceuticals in September,
Chuck Caprariello, Ranbaxy’s executive director of marketing and
development, calls this area the "fertile crescent of the
industry" and hopes to develop business alliances here. Ranbaxy
in India has a marketing alliance with Indianapolis-based Eli Lilly
"We take pride in saying we are a vertically integrated company
— we make products from the very beginning to the very end,"
says Caprariello. "We take raw material, put it in dosage form,
and market the product."
Ranbaxy’s sales and marketing strategies are devised from the College
Road headquarters, but it contracts its sales representatives from
HMS Sales and Marketing, based in Jacksonville. "We promote the
product as a generic alternative to buyers such as at Pathmark and
ShopRite," says Caprariello.
An alumnus of Columbia, Class of 1971, Caprariello has spent his
until now working at major pharmaceutical firms: "I had had
in sales management, product management, group product management,
strategic development, and business development." As one of the
first members of Ranbaxy’s core management team, he is enjoying the
opportunity to wrap all those jobs into one.
Caprariello did not seek out publicity and, in fact, was reticent
to give an interview: "We are a conservative global company and
are very careful about growing our business." But he is willing
to say that though his 35-year-old company is new to the U.S., it
is "well established on a global basis, and we are very effective
because this is the last market on the globe that we have focused
From New Delhi, India, Ranbaxy moved to the Middle East, the Pacific
Rim, and Europe, before starting 3 1/2 years ago in North Carolina.
Three-fourths of the research needed to formulate the compound of
a "new" generic product is done in India, and the rest is
done at Ohm Laboratories. The FDA audits products and sites in both
"Our products are approved by the FDA based on the composition
of the product, but there is some possibility of variation with shape
and color and size of the actual dosage form," he says. "We
say we have the generic equivalent, thoroughly reviewed and approved
by the Food and Drug Administration. The FDA says it is in every way
equivalent to the brand and will give the desired therapeutic
The original, or pioneer, drugs go through rigorous testing for
toxicity and interactions with the body. Beth Leahy, corporate vice
president of communications at Covance, says it takes about $500
and up to 15 years to bring a product from discovery to market.
at the Carnegie Center, her firm operates in 17 countries and recently
handled the clinical tests for Pfizer’s impotence drug Viagra.
But given the narrow profit margins that generics yield, the FDA
process could be considered comparably demanding and significant in
terms of time and cost. "It is an extensive process that many
people characterize as simplistic," says Caprariello, "but
the review process can be as long as 24 months."
He cites the essential chemical work needed to substantiate the
to show the substance is equivalent to the pioneer drug. "You
have to develop and formulate the product in a dosage form, to show
that all the inactive and active ingredients are compatible, to show
good manufacturing practice, and to show bioequivalency."
Bharat Patel, president of Neil Laboratories, agrees. Particularly
to a small start-up like Patel’s, the FDA review process usurps large
chunks of a budget. He is about to enter a period of very rapid
from 12 to 40 or 50 employees, but he now markets 12 over-the-counter
"Out of my 12 employees, I have six people doing quality
They do insist that one person cannot do too many things. Even if
you don’t have enough work they don’t care about it." Patel
that to get even an over-the-counter product appropriately registered
with the FDA costs from $15,000 to $50,000.
The ethical or prescription generics, in contrast, require from
up to a $1 million to get through the FDA. Ranbaxy has managed to
take two of its ethical products over those FDA hurdles: an
and antibiotic drug named cefaclor (an equivalent to Lilly’s Ceclor)
and an anti-ulcer drug, ranitidine, that can substitute for
Though its primary focus is pharmaceutical products, Ranbaxy also
has certain nutritional items. Like Xechem in New Brunswick, it is
importing ginseng — taken as an "energy booster" —
and is selling it under private label.
The pressures brought on by the economics of managed care can only
help the growth of generic drug companies. Says Caprariello:
generic prescriptions have been written in greater numbers than for
branded, and that is expected to increase over time."
— Barbara Fox
Suite 2100, Princeton 08540. Dipak Chattaraj, managing director.
C, North Brunswick. Also at 1385 Livingston Avenue, New Brunswick.
Mailing address: Box 279, Franklin Park 08823-0279. Arun Heble,
A national clearinghouse for women’s health information
will expand to New Brunswick next July. "We link consumers with
local and national health resources — we conduct topic-specific
information searches on behalf of women," says Amy Niles,
director. "And we disseminate information on the Internet and
partner with leading organizations and corporations to develop
women’s health initiatives."
Until last July her organization was part of Columbia Hospital for
Women, though it operated nationally. "By being independent, we
can better fulfill our national mission," says Niles.
The center will keep its offices at 5255 Loughboro Road in Washington,
D.C., but Niles will spend "a good deal of time up there"
and marketing director Elizabeth Battaglino will move to New
Heidi Rosvald, editor of the bimonthly newsletter, National Women’s
Health Report, will remain in Washington.
Niles said the move resulted from a cold mailing from Christopher
Palladino, the president of the New Brunswick Development Corporation,
which is opening a shared office/incubator for healthcare corporations
at its Albany Street headquarters.
"I respond to everything that crosses my desk because you never
know what will be of interest. So I got on the phone and invited them
down," says Niles. "The concept of being together in a
with other nonprofits and sharing resources is an admirable goal.
And there are a tremendous amount of health resources in New Jersey.
It was many months of thinking and decision making, but we thought
it was worth taking a risk."
Amy Lefkowitch Niles grew up in Manhattan where her
mother was a music educator at a Brooklyn high school and her father
owned a large sheet music store on the Lower East Side. After going
premed at the University of Rochester, Class of 1979, she went into
healthcare administration at a medical center, eventually becoming
a vice president for planning, and then worked in the Washington area
for Medlantic Health Care Group and Columbia Hospital for Women, and
became full time executive director of the clearinghouse in 1992.
Niles’ $300,000 budget is covered by memberships and private grants
and contributions, and she hopes to expand the funding to include
contributions from foundations and government grants. She says that
though the organization receives money from pharmaceutical companies
it is not influenced by these contributions.
"We identify the subjects we want to cover next year, and then
we might seek funding for one of the topics. But we specify that the
newsletter and our other initiatives must present a comprehensive,
balanced picture to the consumer and must not be influenced by the
sponsors. The pharmaceutical industry in the past has clearly
our mission and what the consumers need and I expect to have continued
positive relations with the industry."
— Barbara Fox
Street Plaza, 8th Floor, New Brunswick. Amy Niles, executive director.
202-537-4015; fax, 301-320-3762. E-mail: email@example.com. Home
Another Princeton area company making progress in heart
health is EchoCath. In a press release dated Friday, May 8, the Route
1 North-based medical device manufacturer announced that the efficacy
of its blood-flow measurement system, EchoFlow, had been validated
in pre-clinical tests at the University of Louisville.
EchoFlow is a tool to aid cardiovascular surgery: a sensor is placed
on the surface of an artery where blood-flow velocity measurements
are taken and data about blockages in the artery can be collected.
"The surgeons can use this to explore along the surfaces of an
artery to choose where best to place the attachment of the bypass,
the anastomosis," says Frank A. DeBernardis, the president and
CEO of EchoCath. "Secondly after you’ve done anastomosis and made
the bypass into an artery it helps to assess the procedure.
He suggests that the device could be used on several types of arteries
and could also help to perform dialysis access grafts, as well as
other applications. "One possibility is to make this into an implantable
sensor so it could be a long-term monitor of the performance of bypass
procedures of arteries," he says.
The system was successfully tested on a carotid artery at Mt. Sinai
Hospital. The test at the University of Louisville saw the sensor
placed on a coronary artery of a beating heart. The positive results
will allow EchoCath to receive roughly $315,000 in product development
funding per a licensing agreement with Medtronic, a Minneapolis-based
partner. "This is multifaceted," says DeBernardis. "It’s
a core platform technology. What we’ve demonstrated is an epivascular
609-987-8400; fax, 609-987-1019. E-mail: firstname.lastname@example.org.
Stock symbol: ECHTA
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— the web site for U.S. 1 Newspaper in Princeton, New Jersey.