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» 23/07/2009 [Company watch]
China Aoxing Pharmaceutical Corp. Receives Renewal of GMP Certification for Capsule Dosage Form of Pharmaceutical Products
» 15/03/2010 [Industry news]
Recordati S.p.A And Lee Pharmaceutical Announce Partnership For Zanidip(R) In China
» 26/10/2009 [Finance]
China Growth to Remain Fast in Fourth Quarter, Official Says
» 17/08/2009 [Industry news]
Chindex Posts Profit on Product Sales, Health Services
» 07/05/2010 [Industry news]
Hong Kong: Recall of all products manufactured by Quality Pharmaceutical Lab Ltd
COMPANY NEWS » TOP 50 Pharmas » Baxter International  1    
found files: 5
Baxter International »25/01/2008 [Company watch]
Baxter International outbids Double-Crane, takes full ownership of Baxter Health

On January 25 Baxter International (NYSE:BAX) 25 successfully outbid Beijing Double-Crane Pharmaceutical (SHA: 600062) for the remaining 40% of its Shanghai JV. The stake, previously owned by Worldbest Treeful Pharmaceutical, was put up for auction by the Bank of China after Worldbest Treeful became financially distressed. Baxter International will pay RMB 180 million in a deal that makes Baxter Healthcare (Shanghai) a wholly-owned foreign enterprise. Beijing Double-Crane Pharmaceutical previously announced that it would participate in the auction, hoping to integrate Baxter's infusion products into its business. Baxter Healthcare (Shanghai) was established as a joint venture (JV) between Baxter International and Worldbest Treeful. Worldbest Treeful originally invested USD 4.8 million for the 40% stake in the JV. Baxter Healthcare (Shanghai) is headquartered in Shanghai and is focused on drug infusions, renal products, biotechnology, and anesthesia....   more»

Baxter International »29/01/2008 [Company watch]
Baxter Achieves Record Sales and Earnings for Full-Year 2007

Accelerating R&D and Business Development In 2007, Baxter accelerated its investment in R&D to a record level of $760 million, representing an increase of 24 percent over the prior year. The company obtained approval or launched more than a dozen new products and therapies during the year, and achieved a number of important business and scientific milestones....   more»

Baxter International »29/02/2008 [Company watch]
Baxter heparin scare linked to Chinese maker, US FDA also accused

Another US drug scare has been linked to Chinese manufacturers. At the center of the scandal is Baxter's heparin product, production of which was halted February 11 in the US after hundreds of reports of side effects and four deaths were linked to the product. According to news reports, Baxter sources the drug's API from a US supplier who, in addition to a US plant, also operates a plant in China. Further investigation revealed that the US FDA never inspected the Chinese facility, a mandatory step for any manufacturer supplying drug ingredients to the US. Though, like the recent RU 486 scare, there is no evidence tying the Chinese plant to the adverse reactions, media accounts have turned an accusing eye (again) on Chinese drug manufacturers; this time, however, the US FDA shares the glare. One US congressman has even called for the resignation of FDA chief von Eschenbach. The incident has had far reaching effects on the US healthcare market as well. Baxter manufactures approximately 50% of heparin sodium used in the US, and the recent halt to production has the US FDA encouraging other makers, such as APP Pharmaceuticals (NASDAQ: APPX), to increase production. The stock price of APP Pharmaceuticals risen as much as 8% in response....   more»

Baxter International »30/05/2008 [Company watch]
Baxter, China and Toxic Heparin

Eighty-one deaths in the United States have been linked to allergic reactions to a Chinese-concocted contaminant in the widely used blood thinner heparin. The contaminant is an animal cartilage-derived oversulfated chondriotin sulfate. This ersatz non-FDA-approved chemical poorly mimics heparin but costs one one-hundredth of the price of legitimate heparin. Last month, FDA Commissioner Andrew Von Eschenbach told the US Senate that the replacement of heparin was not inadvertent, but an intentional act that was by “virtue of economic fraud.” This fraud joins several recent Chinese-initiated toxic chemical substitutions executed to save money for the Chinese suppliers while ultimately costing their American counterparts billions of dollars in litigation expenses and product recalls. The recalls included tainted pet food that killed hundreds of pets, after Chinese suppliers substituted melamine for wheat gluten; nephrotoxic melamine is cheaper than wheat gluten and is difficult to detect. Fake Colgate toothpaste was found contaminated with antifreeze that can cause kidney failure, convulsions, coma, or even death. There was excessive lead in paint on toys made in China that forced Mattel and other US toymakers to remove millions of toys from stores. In addition, there are over 350,000 web sites selling fake Chinese-manufactured Viagra and other fake US patented medicines to unsuspecting consumers who think they are purchasing the real thing. Where is the FDA in all these shenanigans? Apparently, nowhere. In the case of the toxic heparin, the FDA never even inspected the facility making the active pharmaceutical ingredient [API] for heparin. Since 75% of all API’s used by pharmaceutical companies are imported mainly from China and India, the FDA must have an effective yet timely response system to inspect proposed API facilities. Not only does this not exist, but also the FDA lacks funding to carry out its inspection duties. It is estimated that the FDA needs to spend $225 million on foreign plant inspections every other year. The FDA is budgeted $9 million. The time between plant inspections in the US is two years. In China, it is presently thirty years. This is because there are only 20 API facility visits per year to China for their 714 API facilities, which comes to a 30 years average time span between visits. In China, this does not include chemical manufacturers who may supply chemicals to the pharmaceutical industry. In this case, the Chinese FDA, the State Food and Drug Administration [SFDA] does not register the companies as API’s. Thus, they are exempt from Chinese SFDA regulations because they are classified as chemical manufacturers. And it was an exempt chemical manufacturer, Changzhou SPL Company Ltd., who supplied adulterated heparin to Baxter (BAX)-- the pharmaceutical company that supplies the vast majority of heparin used in the United States. When the FDA finally got around to inspect the manufacturing facility of Changzhou SPL, on a 5-day visit ending on February 26, 2008 there were numerous serious violations noted. The gist of FDA investigator Regina Brown’s report is summarized: There were no critical processing steps identified for Heparin Sodium. There were no documented steps identified for the removal of toxins such as heavy metals, bacteria, endotoxins and other impurities. There were no annual test results available. Basic written records such as set temperature and times as well as user observations during the manufacturing process was not recorded. When lots were tested and failed various tests such as the Nitrogen Determination Test, the investigations were recorded as being complete when in fact there was no determination recorded of why the sample failed the test in the first place. There was no impurity profile established for Heparin Sodium USP and no evaluation for degradants during stability program testing. An unacceptable (to the FDA) workshop vendor sold ingredients used in the manufacture of Heparin Sodium. The inside surface of large, "cleaned” tanks used in the final ?manufacturing? step, after both were very scratched, with unidentified material adhering to the insides and the tanks’ inverted handles held liquid, which spilled to the bottom of the tank when it was up righted. There was no written procedure showing that the tanks were dedicated to a particular process step. Raw material inventory records as well as waste records were incomplete. The shortcomings noted on the inspection report of Changzhou SPL Company Ltd. were so onerous, the FDA banned Chinese heparin imports into the United States. But this latest episode of the FDA not enforcing its own quality controls (until Americans die) belie the FDA’s ability to protect Americans from substandard manufactured drugs. If you buy any other product in the United States such as a car, toy or appliance, the country of origin must be displayed. Why is there no such disclosure for prescription drugs? Many prescription medicines that United States consumers buy are composed of active ingredients made in China. I wonder how many Americans would feel safe swallowing medicines coming from a country with the lowest quality control standards in the world....   more»

Baxter International »22/05/2009 [Company watch]
Baxter Commits 1 Billion RMB to Increase Manufacturing in China

Baxter Plans Big Investment in China Medical Instruments Industry...   more»

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