Generic Manufacturers

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Prescription Generics

Generic Pharma: Start-ups

Generic Pharma: New in Town

Generic Pharma: Expansions

Generic Pharma: Crosstown Moves

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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.orgIn 100,000 square feet on Brunswick Pike, the former HeinemannElectric facility, Accumed makes such generic products as antacids,laxatives, enzyme supplements, stomach remedies, nasal and throatsprays, oral care items, and topical products. According to itswebsite, recent products include a tooth whitening gel that competeswith Colgate’s Simply White, soluble fiber caplets similar toCitrucel, Slide-a-Mint antibacterial breathstrips, and a formula forPeriColace, a laxative plus stool softener.Qpharma, which operates within Accumed’s headquarters on BrunswickPike, has obtained a $.5 million loan guarantee from the New JerseyEconomic Development Authority for a $2.04 million Sun National Bankloan. At the time of the loan (U.S. 1, October 24, 2004), Qpharma wassaid to be making prescription generic nasal spray formulations andoral liquid products, and it was going to use the money for equipmentand working capital. The company did not return two calls from areporter.Guardian Drug Co., 2 Charles Court, Box 915, Dayton08810. Arvind Dhruv, president. 609-860-2600; fax, 609-860-8008. Homepage: www.guardiandrug.comGuardian Drug is a 20-year-old private label manufacturer of over thecounter pharmaceuticals, chiefly generic stomach remedies. It boughtthe former Block Drug building in Dayton with the help of a $7.5million bond from the New Jersey Economic Development Authority andmoved from 72 Prince Street in Trenton in 2000. Among its products isa re-formulated Ex-Lax, and its top sellers – of a couple of millionunits a year – are the Tums look-alikes, antacids with calcium.”Though we sell to certain customers that export, our major market isthe big retail chains,” says Vinima Karov, spokesperson. The chainsinsist on national brand equivalents, or NBEs. “It has to match iningredients, quality, taste, and look, and it has to be as close tothe packaging as possible.” “We also do contract manufacturing fornational 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.comWith 9,100 global employees, Ranbaxy Laboratories Ltd. is India’slargest pharmaceutical company. Last February it marked sales of $1billion for a 12-month period. It sells 93 products, representingeight therapeutic classes, in more than 100 countries. It hasfactories 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, includingits over the counter manufacturing site, Ohm Laboratories on BlackHorse Lane in North Brunswick, and the OTC and prescription sites onLivingston Avenue and Terminal Road in New Brunswick. All thesefacilities make solid dosages; liquids are made in upstate New York.Ohm Laboratories produces private label, finished consumer goods. Thismeans that the product is ready to be put on the shelf by large retailoutlets, mass merchandisers, and food outlets. In the prescriptionarea, Ranbaxy has a generic version of accutane, an acne medication,and one for augmentin, a broad spectrum antibiotic used for middleear infections. It is marketing the generic equivalent to Schering’sClaritin, known as Loratadine.Last month Ranbaxy received tentative approval from the Food and DrugAdministration to make and market a generic version of a treatment fordementia associated with Alzheimer’s. Promoted by Teaneck-based Eisaiand Pfizer, Aricept’s patent does not expire until 2010. Only thenwill Ranbaxy be able to make donepezil hydrochloride tablets in 5 and10 mg doses. “We were the first to file, so according to the 1983Waxman-Hatch law, that will give us exclusivity in the marketplace for180 days,” says a spokesperson.Top Of PagePrescription GenericsSandoz Inc. (ADR), 506 Carnegie Center, Suite 400,Princeton 08540. John Sedor, CEO. 609-627-8500; fax, 609-627-8682.Home page: www.us.sandoz.comGeneva Pharmaceuticals is now owned by Sandoz, which has an R&D centerin Dayton and a headquarters for staff operations at the CarnegieCenter. Manufacturing operations are in Colorado.Among its recent launches is a generic Rebetolr (Ribavirin), which isused in combination with interferon to treat hepatitis C. “People withhepatitis C who need this drug therapy will now be able to obtain itmore readily and receive excellent patient support,” said CEO JohnSedor in a press release.Stada Pharmaceuticals Inc., 5 Cedar Brook Drive, CedarBrook Corporate Center, Cranbury 08512. Christian Scheiner, president.609-409-5999; fax, 609-409-5995. Www.stadausa.comGermany-based Stada bought the portfolio and other assets of MovaLaboratories in 2002, and it made other acquisitions from Wyeth andESI Lederle. Now it markets and sells generic drugs and is among thetop 10 generics suppliers in Europe. It also develops branded andspecialty pharmaceuticals.In this country it offers prescription antibiotics, non-steroidalanti-inflammatory drugs (NSAIDs), anti-hypertensives, andulcer/heartburn medications (H2 receptor antagonists) in capsule,tablet and pediatric dosage forms. Last year it launched methotrexateproduct, Rheumatrex Dose Pack, which it had bought from Wyeth. Stadaaims to focus on the rheumatology market.Xechem Inc./Xechem International Inc. (XKEM), 100 JerseyAvenue, 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.comFounded in 1990, Xechem does research, development, and production ofgeneric and proprietary drugs, including ginseng and melatoninproducts. Among Xechem’s generic drugs are Vancomycin, Paclitaxel, andBleomycin. Paclitaxel has been compared with Bristol-Myers Squibb’sTaxol for treating refractory ovarian and breast cancer. In additionto labs in Gaithersburg, Maryland, it has sites in India, Hong Kong,and China.Top Of PageGeneric Pharma: Start-upsAustarpharma LLC, 1 Deer Park Drive, Suite L 1, MonmouthJunction Yuqing Guo, scientist. 732-329-2879; fax, 732-329-2801. Homepage: www.austarpharma.comAustarpharma is researching and developing generic drugs and newchemical entitites, focusing on new drug delivery routes. It plans tostaff up to 30 people at Princeton Corporate Plaza.Yuquing Guo, the scientist in charge, graduated from BeijingUniversity in 1970 and earned his PhD in physical chemistry from theSUNY Buffalo. There he met fellow Austarpharma scientist Sam Lu, whowent to Fudan University in Singapore, Class of 1984.The company also has a warehouse, nearly 50,000 square feet, inColumbus Circle, Raritan, and plans to build a development center withproduction machines and a chemistry lab, but has not startedconstruction.Top Of PageGeneric Pharma: New in TownApicore, 7 Deer Park Drive, Princeton Corporate Plaza,Suite M1, Monmouth Junction 08852. 732-748-8882; fax, 732-748-8929.Home page: www.apicore.comApicore was founded in 2004 to develop and manufacture the activepharmaceutical ingredients used for generic pharmaceuticals. It movedto Princeton Corporate Plaza and currently has nine workers in 3,200square feet.Sanjay Bharvav, vice president of operations, has 20 years experiencemanufacturing active pharmaceutical ingredients in this country and inIndia, and he formerly worked for the fourth largest company in India.Bharvav is a 1981 graduate of the University of Gujarat and has amaster’s degree from the same university.Zenotech Inc., 1 Deer Park Drive, Princeton CorporatePlaza, Suite H-6, Monmouth Junction 08852. Jay Chigurupati PhD MBA,chief executive officer. 7332-438-1622. Home page: www. zenotechinc.comZenotech is a generic pharmaceutical company that also does contractresearch. According to its website, it will launch generic monoclonalantibody therapeutics soon. It has received clearance to make ageneric version, Rituximab, of Genentech’s Rituxan (protein’s nameRituximab) and plans to market this in India next year.Top Of PageGeneric Pharma: ExpansionsZydus Pharmaceuticals USA, 508 Carnegie Center, Suite101, Princeton 08540. Joseph Renner, CEO. 609-275-5125; fax,609-716-6002. Home page: www.zydususa.comBased in India, with 6,000 employees worldwide, Zydus has beenacquiring companies and growing quickly. With 20 employees at theCarnegie Center, Zydus USA aims to provide finished dosageformulations to the generic market. It expanded from 300 AlexanderRoad last year to 9,400 square feet at the Carnegie Center..Founded as Cadila, it was renamed ‘Zydus,’ according to the company’swebsite, because the name “combines the ethos of the Greco-Roman GodZeus and the dawn of a new era. Zydus like Zeus also symbolizes thegroup’s aspirations to contribute to the welfare of the people and tosociety 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.comThis U.S. office of a generic drug manufacturer was founded in 1988and is based in Hyderabad. It has had three products approved by theU.S. Food and Drug Administration for marketing in the U.S. Justapproved as an Abbreviated New Drug Application (ANDA) is a diabetesdrug, Metformin.Its product portfolio includes antibiotics, anti-retro virals, CVS,CNS, gastroenterologicals, and anti-allergics, and it markets productsto more than 100 companies. Vice president Prasada Reddy Kambham hasfive employees at Princeton Meadows Office Center. He went to SVUniversity in South India, Class of 1988, and has a master’s degreefrom City University of New York.Top Of PageGeneric Pharma: Crosstown MovesGlenmark Pharmaceuticals Inc. USA, 1 Independence Way,Suite 210, Princeton 08540. Terry Coughlin, president. 609-514-1444;fax, 609-514-1402. Home page: www.glenmarkus.comGlenmark Pharmaceuticals has moved from 4390 Route 1 South toPrinceton Corporate Center, where it has 10 employees. The U.S.subsidiary is helping to file ANDAs (abbreviated new drugapplications) and market-finished formulations in the U.S. market. Thefirm will also register its bulk drugs – the key ingredients that lendmedicines their potency – with the US Food & Drug Administration,according to the company’s website.The company’s website defines its target market: “The internationalgenerics market offers a huge opportunity for Indian pharma companies.As many as 60 products with more than $40 billion in sales areexpected to lose their patents over the coming decade. In the USalone, this generics opportunity is expected to be worth $19 billionby 2005.”Indian companies are moving the value chain by moving to developedmarkets and from bulk drugs to formulation exports. As a result,Indian companies are expected to produce six of the top ten drugs thatare scheduled to lose their patent protection over the next fiveyears,” says the company in the website statement.Previous StoryNext StoryCorrections or additions?This page is published by PrincetonInfo.com— the web site for U.S. 1 Newspaper in Princeton, New Jersey.

CE – US1

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