Prescription Generics

Generic Pharma: Start-ups

Generic Pharma: New in Town

Generic Pharma: Expansions

Generic Pharma: Crosstown Moves

Corrections or additions?

These articles were prepared for the March 9, 2005 issue of U.S. 1

Newspaper. All rights reserved.

Generic Manufacturers

Medico joins several other big generic manufacturers in central New

Jersey, namely Accumed, Guardian Drug, and Ranbaxy. Accumed and

Guardian focus on over the counter generics, and Ranbaxy does both OTC

and "ethical" or prescription drugs.

Notable among the prescription drug generic manufacturers are Sandoz

(formerly Geneva Pharmaceuticals, with 300 people divided between

Dayton and the Carnegie Center) and Stada Pharmaceuticals, with 30

people at Cedar Brook Corporate Center. Others are Apothecon, a

Bristol-Myers Squibb generic manufacturer on Scudders Mill Road;

Xechem, which researches and produces proprietary and generic drugs on

Jersey Avenue in New Brunswick; and Neil Laboratories, located at 55

Lake Drive in Hightstown.

Accumed Inc., 2572 Brunswick Pike, Lawrenceville 08648.

Yogsh Besai, quality control manager. 609-883-1818; fax, 609-883-2288.

Www.accumed.org

In 100,000 square feet on Brunswick Pike, the former Heinemann

Electric facility, Accumed makes such generic products as antacids,

laxatives, enzyme supplements, stomach remedies, nasal and throat

sprays, oral care items, and topical products. According to its

website, recent products include a tooth whitening gel that competes

with Colgate’s Simply White, soluble fiber caplets similar to

Citrucel, Slide-a-Mint antibacterial breathstrips, and a formula for

PeriColace, a laxative plus stool softener.

Qpharma, which operates within Accumed’s headquarters on Brunswick

Pike, has obtained a $.5 million loan guarantee from the New Jersey

Economic Development Authority for a $2.04 million Sun National Bank

loan. At the time of the loan (U.S. 1, October 24, 2004), Qpharma was

said to be making prescription generic nasal spray formulations and

oral liquid products, and it was going to use the money for equipment

and working capital. The company did not return two calls from a

reporter.

Guardian Drug Co., 2 Charles Court, Box 915, Dayton

08810. Arvind Dhruv, president. 609-860-2600; fax, 609-860-8008. Home

page: www.guardiandrug.com

Guardian Drug is a 20-year-old private label manufacturer of over the

counter pharmaceuticals, chiefly generic stomach remedies. It bought

the former Block Drug building in Dayton with the help of a $7.5

million bond from the New Jersey Economic Development Authority and

moved from 72 Prince Street in Trenton in 2000. Among its products is

a re-formulated Ex-Lax, and its top sellers – of a couple of million

units a year – are the Tums look-alikes, antacids with calcium.

"Though we sell to certain customers that export, our major market is

the big retail chains," says Vinima Karov, spokesperson. The chains

insist on national brand equivalents, or NBEs. "It has to match in

ingredients, quality, taste, and look, and it has to be as close to

the packaging as possible." "We also do contract manufacturing for

national brands."

Ranbaxy Inc., 600 College Road East, Suite 2100,

Princeton 08540. Dipak Chattaraj, president. 609-720-9200; fax,

609-720-1155. Home page: www.ranbaxyusa.com

With 9,100 global employees, Ranbaxy Laboratories Ltd. is India’s

largest pharmaceutical company. Last February it marked sales of $1

billion for a 12-month period. It sells 93 products, representing

eight therapeutic classes, in more than 100 countries. It has

factories in seven countries and operates in 34 countries.

Ranbaxy Inc., based on College Road, is its wholly owned subsidiary.

Ranbaxy has more than 260,000 square feet for manufacturing, including

its over the counter manufacturing site, Ohm Laboratories on Black

Horse Lane in North Brunswick, and the OTC and prescription sites on

Livingston Avenue and Terminal Road in New Brunswick. All these

facilities make solid dosages; liquids are made in upstate New York.

Ohm Laboratories produces private label, finished consumer goods. This

means that the product is ready to be put on the shelf by large retail

outlets, mass merchandisers, and food outlets. In the prescription

area, Ranbaxy has a generic version of accutane, an acne medication,

and one for augmentin, a broad spectrum antibiotic used for middle

ear infections. It is marketing the generic equivalent to Schering’s

Claritin, known as Loratadine.

Last month Ranbaxy received tentative approval from the Food and Drug

Administration to make and market a generic version of a treatment for

dementia associated with Alzheimer’s. Promoted by Teaneck-based Eisai

and Pfizer, Aricept’s patent does not expire until 2010. Only then

will Ranbaxy be able to make donepezil hydrochloride tablets in 5 and

10 mg doses. "We were the first to file, so according to the 1983

Waxman-Hatch law, that will give us exclusivity in the marketplace for

180 days," says a spokesperson.

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Prescription Generics

Sandoz Inc. (ADR), 506 Carnegie Center, Suite 400,

Princeton 08540. John Sedor, CEO. 609-627-8500; fax, 609-627-8682.

Home page: www.us.sandoz.com

Geneva Pharmaceuticals is now owned by Sandoz, which has an R&D center

in Dayton and a headquarters for staff operations at the Carnegie

Center. Manufacturing operations are in Colorado.

Among its recent launches is a generic Rebetolr (Ribavirin), which is

used in combination with interferon to treat hepatitis C. "People with

hepatitis C who need this drug therapy will now be able to obtain it

more readily and receive excellent patient support," said CEO John

Sedor in a press release.

Stada Pharmaceuticals Inc., 5 Cedar Brook Drive, Cedar

Brook Corporate Center, Cranbury 08512. Christian Scheiner, president.

609-409-5999; fax, 609-409-5995. Www.stadausa.com

Germany-based Stada bought the portfolio and other assets of Mova

Laboratories in 2002, and it made other acquisitions from Wyeth and

ESI Lederle. Now it markets and sells generic drugs and is among the

top 10 generics suppliers in Europe. It also develops branded and

specialty pharmaceuticals.

In this country it offers prescription antibiotics, non-steroidal

anti-inflammatory drugs (NSAIDs), anti-hypertensives, and

ulcer/heartburn medications (H2 receptor antagonists) in capsule,

tablet and pediatric dosage forms. Last year it launched methotrexate

product, Rheumatrex Dose Pack, which it had bought from Wyeth. Stada

aims to focus on the rheumatology market.

Xechem Inc./Xechem International Inc. (XKEM), 100 Jersey

Avenue, Building B, Suite 310, New Brunswick 08901-3279. Ramesh C.

Pandey, chairman, president, CEO. 732-247-3300; fax, 732-247-4090.

Home page: www.xechem.com

Founded in 1990, Xechem does research, development, and production of

generic and proprietary drugs, including ginseng and melatonin

products. Among Xechem’s generic drugs are Vancomycin, Paclitaxel, and

Bleomycin. Paclitaxel has been compared with Bristol-Myers Squibb’s

Taxol for treating refractory ovarian and breast cancer. In addition

to labs in Gaithersburg, Maryland, it has sites in India, Hong Kong,

and China.

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Generic Pharma: Start-ups

Austarpharma LLC, 1 Deer Park Drive, Suite L 1, Monmouth

Junction Yuqing Guo, scientist. 732-329-2879; fax, 732-329-2801. Home

page: www.austarpharma.com

Austarpharma is researching and developing generic drugs and new

chemical entitites, focusing on new drug delivery routes. It plans to

staff up to 30 people at Princeton Corporate Plaza.

Yuquing Guo, the scientist in charge, graduated from Beijing

University in 1970 and earned his PhD in physical chemistry from the

SUNY Buffalo. There he met fellow Austarpharma scientist Sam Lu, who

went to Fudan University in Singapore, Class of 1984.

The company also has a warehouse, nearly 50,000 square feet, in

Columbus Circle, Raritan, and plans to build a development center with

production machines and a chemistry lab, but has not started

construction.

Top Of Page
Generic Pharma: New in Town

Apicore, 7 Deer Park Drive, Princeton Corporate Plaza,

Suite M1, Monmouth Junction 08852. 732-748-8882; fax, 732-748-8929.

Home page: www.apicore.com

Apicore was founded in 2004 to develop and manufacture the active

pharmaceutical ingredients used for generic pharmaceuticals. It moved

to Princeton Corporate Plaza and currently has nine workers in 3,200

square feet.

Sanjay Bharvav, vice president of operations, has 20 years experience

manufacturing active pharmaceutical ingredients in this country and in

India, and he formerly worked for the fourth largest company in India.

Bharvav is a 1981 graduate of the University of Gujarat and has a

master’s degree from the same university.

Zenotech Inc., 1 Deer Park Drive, Princeton Corporate

Plaza, Suite H-6, Monmouth Junction 08852. Jay Chigurupati PhD MBA,

chief executive officer. 7332-438-1622. Home page: www. zeno

techinc.com

Zenotech is a generic pharmaceutical company that also does contract

research. According to its website, it will launch generic monoclonal

antibody therapeutics soon. It has received clearance to make a

generic version, Rituximab, of Genentech’s Rituxan (protein’s name

Rituximab) and plans to market this in India next year.

Top Of Page
Generic Pharma: Expansions

Zydus Pharmaceuticals USA, 508 Carnegie Center, Suite

101, Princeton 08540. Joseph Renner, CEO. 609-275-5125; fax,

609-716-6002. Home page: www.zydususa.com

Based in India, with 6,000 employees worldwide, Zydus has been

acquiring companies and growing quickly. With 20 employees at the

Carnegie Center, Zydus USA aims to provide finished dosage

formulations to the generic market. It expanded from 300 Alexander

Road last year to 9,400 square feet at the Carnegie Center..

Founded as Cadila, it was renamed ‘Zydus,’ according to the company’s

website, because the name "combines the ethos of the Greco-Roman God

Zeus and the dawn of a new era. Zydus like Zeus also symbolizes the

group’s aspirations to contribute to the welfare of the people and to

society at large."

Aurobindo Pharma Ltd., 666 Plainsboro Road, Suite 210,

Plainsboro 08536. Prasada Reddy Kambham, vice president. 609-716-1190;

fax, 609-716-1142. Home page: www.aurobindo.com

This U.S. office of a generic drug manufacturer was founded in 1988

and is based in Hyderabad. It has had three products approved by the

U.S. Food and Drug Administration for marketing in the U.S. Just

approved as an Abbreviated New Drug Application (ANDA) is a diabetes

drug, Metformin.

Its product portfolio includes antibiotics, anti-retro virals, CVS,

CNS, gastroenterologicals, and anti-allergics, and it markets products

to more than 100 companies. Vice president Prasada Reddy Kambham has

five employees at Princeton Meadows Office Center. He went to SV

University in South India, Class of 1988, and has a master’s degree

from City University of New York.

Top Of Page
Generic Pharma: Crosstown Moves

Glenmark Pharmaceuticals Inc. USA, 1 Independence Way,

Suite 210, Princeton 08540. Terry Coughlin, president. 609-514-1444;

fax, 609-514-1402. Home page: www.glenmarkus.com

Glenmark Pharmaceuticals has moved from 4390 Route 1 South to

Princeton Corporate Center, where it has 10 employees. The U.S.

subsidiary is helping to file ANDAs (abbreviated new drug

applications) and market-finished formulations in the U.S. market. The

firm will also register its bulk drugs – the key ingredients that lend

medicines their potency – with the US Food & Drug Administration,

according to the company’s website.

The company’s website defines its target market: "The international

generics market offers a huge opportunity for Indian pharma companies.

As many as 60 products with more than $40 billion in sales are

expected to lose their patents over the coming decade. In the US

alone, this generics opportunity is expected to be worth $19 billion

by 2005.

"Indian companies are moving the value chain by moving to developed

markets and from bulk drugs to formulation exports. As a result,

Indian companies are expected to produce six of the top ten drugs that

are scheduled to lose their patent protection over the next five

years," says the company in the website statement.


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