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FDA finds US drug research firm faked documents

Massive Recall Of Fifty Variations Of Children’s Tylenol,
Motrin, Zyrtec & Benadryl Products Forces FDA Into The Spotlight

Pharmaceutical Giants Caught Supplying Cartels With
Tons of Bulk Ingredients to Produce Meth

2009 There are 1800 foreign funded pharmaceutical enterprises in China. The top 20 pharmaceutical companies set up joint ventures or wholly owned facilities in China. This suggests that market conditions have never been more challenging, with competition at an all-time high.

Pfizer produces and markets more than 40 drugs in China all of which meet chinese pharmacopeia quality control.

Pfizer has manufacturing facilities in Dalian, Suzhou and Wuxi. The Pfizer Dalian facility, built in 1989 jointly with Dalian Pharmaceuticals was the first to get certification in China.

GlaxoSmithKline has more than 2000 employees in China, and its drugs are sold in 60 cities. GlaxoSmithKline mainly sells drugs treating HIV, asthma and infection.

Merck sells antibiotics prostate drugs, cardiovascular drugs, pain relievers, osteoporosis and vaccines. Merck set up its first joint venture in China in 1994.

Novartis has four manufacturing facilities in Beijing and Shanghai. Novartis core businesses involve patented drugs, generic drugs, eye protection drugs and health products. Novartis Beijing was founded by Novartis AG and Beijing Pharmaceutical group and Beijing Zizhu Pharmaceuticals in 1987 and was the first foreign pharmaceutical company in China.

Sanofi-Aventis, the German-French company, sells several drugs in China.

AstraZeneca has headquarters in Shanghai, with 25 branch offices in major cities. In 2001 AstraZeneca established its largest manufacturing site in Asia in Wuxi. AstraZeneca sells several products, including the atypical antiPsychotic used in the management of schizophrenia and bipolar disorder Seroquel(quetiapine) and Nexium(esomeprazole).

AstraZeneca has nearly 3,000 employees working in manufacturing, sales, clinical research and new product development.

AstraZeneca has a presence in more than 110 targeted cities, with around 800 marketing representatives.

Bristol-Myers Squibb was one of the earliest to enter Chinese market.

Johnson & Johnson has established subsidiaries which include Shanghai Johnson & Johnson Pharmaceuticals, Ltd, Johnson & Johnson Medical (Shanghai) Ltd, Johnson & Johnson Medical (China) Ltd, Johnson & Johnson (China) Ltd, Johnson & Johnson (China) Investment Co., Ltd, manufacturing and selling drugs in China.

Wyeth best-seller in China includes Calcium-D.

Roche launched a medical education campaign targeting 3,500 doctors in 20 Chinese cities in 2004.

Schering-Plough is the recognized leader in biotech, genomics and gene therapy. Shanghai Schering-Plough Pharmaceutical Co., Ltd was founded in 1994 as a joint-venture, with Shanghai Pharmaceutical Industry (Group) Corporation and Shanghai Corporation of Pharmaceutical Economic and Technical International Cooperation.

Bayer's invested in the early 1990s in large-scale, world-class facilities in an integrated production site in the Shanghai Chemical Industry Park. Bayer's operations, in Hong Kong, Taiwan, and China are led by management holding companies, with subgroups and production joint ventures operating independently under Bayer's strategic direction.

Bayer has production facilities on stream in all corporately active business lines. Chinese production accounts for an increasing proportion of profit margins. Bayer is engaged in a number of cooperation projects with some of the foremost research institutes and universities in China, to conduct research in the field of innovative materials, health care and crop science. Bayer cooperates with the Chinese Academy of Science and affiliated institutes such as the Institute of Materia Medica and the Kunming Institute of Botany in Yunnan with the aim to identify new compounds in the healthcare and crop science field. There are also a number of projects currently being started in polymers research.

Bayer supports a number of chairs and programes for research and teaching at Chinese universities. These include the Tsinghua-Bayer Public Health and HIV/AIDS Media Studies Program, a national platform designed to play a key role in China's public health system. Bayer HealthCare supports a chair for Healthcare Management at the China European International Business School (CEIBS) in Shanghai.

Boehringer Ingelheim entered Chinese market in 1995 and invested $25 million in a new facility in Shanghai in 2002. Its drugs treating respiratory diseases and cardiovascular diseases are established in Chinese pharmaceutical markets.

Hoechst Marion russell established its China head offices in Beijing in 1995 to manage operations in mainland China and Hong Kong. Hoechst Marion russell has two joint ventures in China, Hoechst Huabei Pharmaceuticals Ltd in Shijiazhuang, a heartland of the Chinese pharmaceutical industry, and Hoechst Shanghai International Pharmaceuticals Ltd.

Eli Lilly set up its first overseas office in Shanghai in 1918 and returned to Shanghai, China in 1993. Eli Lilly main facility is in Suzhou, Jiangsu province and main products include cipro, insulin, and erectile dysfunction drugs.

Abbott Laboratories Ltd sells a series of products including baby food in China.

Among foreign-invested ventures in China, Xian-Janssen Pharmaceutical's success is due to its product line, which includes a range of high-volume sellers: medicines to treat gastronintestinal problems, fungi, allergies and pain, as well as psychosis and epilepsy.

Dr. Paul Janssen's decision to enter China early, to invest inland, and to keep investment plans moving along in the wake of 1989 Tiananmen Square event have helped build good relations with the Chinese government. Paul Appermont and Joos Horsten lead the Xian-Janssen Pharmaceutical project.

Degussa is shifting a large proportion of its pharmaceutical chemicals production from Europe to China in order to take advantage of low-cost manufacturing. Degussa will restructure its large production facilities, the vast majority in Germany, which could result in the transfer of the manufacture of other products to China.

Rhodia is improving its competitive position in analgesics by making a major investment in its Wuxi, China acetaminophen (paracetamol) production facility and consolidating its North American and European operations. Rhodia shuttered its Luling, Louisiana, acetaminophen (paracetamol) operations in 2004 and consolidated production in Roussillon, France and Wuxi, China. Acetaminophen (paracetamol) production capacity will be adjusted to match current consumption levels.

Acetaminophen linked to autism?

Acetaminophen Linked to Lower Empathy Levels

Acetaminophen use in pregnancy linked to kids' behavioral problems

Mechanisms of Acetaminophen-Induced Liver Necrosis

11 Million Bottles Possibly Tainted With Metal Bits

Sankyo has operated a plant for manufacturing the hyperlipemic Mevalotin(pravastatin), anti-inflammatory Loxonin(loxoprofen), antibiotic Banan(cephalosporin antibiotic) and has plans to market hypertensive Olmesartan(angiotensin II receptor antagonists).

Takeda has a manufacturing plant and will be marketing all four global products - the thiazolidinedione with hypoglycemic action Actos(pioglitazone), anti-ulcer proton pump inhibitorTakepron(lansoprazole), gonadotropin-releasing hormone agonist cancer drug Leuplin(leuprolide acetate), and hypertensive Blopress(candesartan).

Yamanouchi owns a manufacturing plant and is marketing anti-ulcer histamine H2-receptor antagonist Gaster(famotidine), urinary impediment treatment Harnal(tamsulosin), a selective alpha blocker used in the symptomatic treatment of benign prostatic hyperplasia and hypertensive calcium channel blocker Hypoca. There are plans to launch Dolner for peripheral circulation and anti-emetic Nazea OD.

Daiichi mainly sells synthetic antibacterials Cravit (oral and injectable levofloxacin) and Tarivid(ofloxacin). It originally planned to launch neurotransmission enhancer Translon too, but after development was halted in Japan, development in China also ended. Sales are behind plan chiefly due to the suspension of Translon's development and the proliferation of generic and copycat versions of Cravit.

Tanabe markets hypertensive Herbesser(diltiazem hydrochloride) and Tanatril (imidapril hydrochloride) .

The China subsidiary Kuangchou Green Cross of Mitsubishi Pharma has been extending transfusion business (manufacturing, sales) since the days of the former Green Cross. Mitsubishi Pharma sold its transfusion business in Japan to Otsuka Pharmaceutical as part of a restructuring. Anti-coagulant Novastan(argatroban) was launched in China in December 2002 and is being sold by a local agent.

Immunosuppressant Prograf(tacrolimus or fujimycin) is being marketed in China by a Fujisawa subsidiary - potential is significant due to the ever increasing number of organ transplants. In 2000, there were 5,501 kidney transplants performed in China, second only to the number in the US (13,372). Sales of immunosuppressant drugs are relatively high. The top 30 drugs by sales in China (hospital market base) included two such drugs: Novartis' immunosuppressant drug used in post-allogeneic organ transplantNeoral(cyclosporine) and Roche's immunosuppressant drug used to prevent rejection in organ transplantation CellCept (mycophenolate mofetil).

Chugai exports white blood cell production stimulant Neutrogin (lenograstim) to China.

Kirin's granulocyte colony-stimulating factor is marketed in China .

Eisai expanded its manufacturing and marketing operations in China and Asia earlier than in the European and US markets. Eisai was the first manufacturer among the US, European and Japanese pharmaceutical firms to manufacture in China via a 100% owned subsidiary which founded in 1994. Eisai sells two global products, anti-ulcer proton pump inhibitors Pariet(rabeprazole) and Alzheimer's acetylcholinesterase inhibitor treatment Aricept(donepezil), and plans to add osteoporosis drug Glakay(menatetrenone) in 2006.

Kyowa Hakko has exported cancer drugs and plans to market the hypertensive dihydropyridine calcium channel blockerConiel(benidipine) and anti-allergy antihistamine and mast cell stabilizer Allelock(olopatadine hydrochloride).

Taisho makes and sells health drinks (tonics) in China, but has no specific plans for prescription medications. The rights to macrolide antibiotic Clarith/Biaxin(clarithromycin) outside Japan are licensed to Abbott.

Terumo is using China as a manufacturing base making products for the US and European and Japanese markets. Terumo is in the process of exploring China as a market.

The first foreign office of the FDA opened November 19, 2008 in Beijing.

Vaccine Scandal in China Crosses “Moral Bottom Line”



recall


2009 McNeil Consumer Healthcare, a division of Johnson & Johnson, announced the recall of several hundred batches of popular over-the-counter medicines, including Benadryl, Motrin, Rolaids, Simply Sleep, St. Joseph Aspirin and Tylenol.

The response was anything but swift.

The recall came 20 months after McNeil first began receiving consumer complaints about moldy-smelling bottles of Tylenol Arthritis Relief caplets.

Johnson & Johnson did not conduct a timely, comprehensive investigation, did not quickly identify the source of the problem, and did not notify authorities in a timely fashion thus prolonging consumer exposure to the products.
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