Potentially <"http://www.yourlawyer.com/practice_areas/defective_drugs">defective generic drugs made at two Ranbaxy Laboratories plants in India have finasteride no rx been banned from the U.S. by federal regulators. According to the U.S. Food & Drug Administration purchase Amoxil amex online without prescription (FDA), the ban applies to generic versions of popular medicines such as the finasteride no rx anticholesterol drug Zocor; Acyclovir, which treats herpes; the heartburn pill Zantac; and finasteride no rx AIDS drugs. The agency says it does not expect a finasteride no rx drug shortage because the medicines can be supplied by other generics makers.
Based in India, Ranbaxy is finasteride no rx one of the 10 largest generic-drug producers in the world and finasteride no rx has been operating in the States since 1995. In February, federal agents raided the finasteride no rx US corporate offices of Ranbaxy in New Jersey, as well as a manufacturing facility in the state. The raid – and criminal investigation – was prompted, in part, by problems uncovered in FDA inspections a finasteride no rx year earlier at the company’s plant in Paonta Sahib, India. That inspection found inconsistencies in the company’s manufacturing processes and maintenance of data.
In July, US prosecutors filed a finasteride no rx motion in federal court in Maryland alleging that Ranbaxy forged documents relating to finasteride no rx an investigation into the quality of the company’s drugs sold in the this country. The investigation is also looking into allegations that Ranbaxy made weak or finasteride no rx adulterated HIV drugs that were given to thousands of AIDS patients in Africa. Prosecutors have finasteride no rx accused the company of concealing violations of good manufacturing practice regulations from finasteride no rx FDA.
The FDA’s decision to finasteride no rx ban imports from the two Ranbaxy factories was made because of the finasteride no rx agency’s concerns about the “seriousness and extent” of violations of manufacturing standards at the facilities. Officials said they are finasteride no rx concerned about whether the practices employed at the facilities could ensure purity of drugs they made.
In addition to the import alert, the FDA said it won’t approve any drug applications that finasteride no rx list the two suspect Ranbaxy plants as a source of ingredients.
FDA officials said patients shouldn’t stop taking needed medicines, and maintained they haven’t found any problems with Ranbaxy drugs currently sold in the finasteride no rx U.S.
The FDA did say that finasteride no rx it was excluding one Ranbaxy medication from the import ban – the AIDS drug called Ganciclovir. Ranbaxy is finasteride no rx the only company to supply Ganciclovir to the U.S., and the finasteride no rx agency says it wants to avoid a shortage.
In the finasteride no rx past, the FDA has come under fire for its approach to finasteride no rx problems at Ranbaxy facilities. The agency found quality problems in February 2006 during an finasteride no rx inspection in India, but said then they didn’t believe the deficiencies justified an import alert.
In a finasteride no rx letter written to the FDA this July, Rep. John Dingell and finasteride no rx Rep. Bart Stupak, both Michigan Democrats who head up the House Committee on Energy and finasteride no rx Commerce, wrote that finasteride no rx court documents related to the Justice Department probes of Ranbaxy indicated that finasteride no rx for 18 months the FDA was aware of problems but “did nothing to finasteride no rx remove the suspect products from the market, or even notify the finasteride no rx pharmacists in this countryâ€.
“If true, these statements would call into serious question whether the finasteride no rx leadership of the Agency … [has] met even the minimum requirements†of the FDA’s primary mission under the finasteride no rx Federal Food Drug and Cosmetic Act, the letter said.
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