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    European Regulatory Roundup: Lilly May Move API Production Outside EU Due to REACH Regulations (17 March 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Eli Lilly Threatens to Move API Production out of the EU in Broadside Against REACH Eli Lilly has warned it may move production of certain active pharmaceutical ingredients (APIs) out of the European Union because of REACH regulations. The production of two of Lilly’s veterinary APIs is tied to the availability of cobalt salts, something it says is becoming a “significant pr...
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    US FDA Inspections in China: An Analysis of Form 483s from 2015

    As the US becomes increasingly dependent on Chinese and Indian active pharmaceutical ingredient (API) and drug manufacturing, a deeper look into the inspection reports from the US Food and Drug Administration (FDA) in China reveals a number of question marks that parallel the same sort of issues found in Form 483s issued after inspections in India. A Focus review (thanks to use of the Freedom of Information Act (FOIA)) of eight FDA Form 483s for Chinese manufacturers i...
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    Swedish Regulators Halt Imports from AstraZeneca’s Indian API Plant

    European imports from AstraZeneca’s now-closed terbutaline sulphate active pharmaceutical ingredient (API) manufacturing facility in Bangalore, India were halted by Sweden’s Medical Products Agency after failed validation runs, according to a recent notice in EudraGMDP. “The concerned API-batches or finished product containing the API should not be imported to the EEA [European Economic Area],” the agency said. “All API batches manufactured during the year 2014 are conce...
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    Compounders Beware: API from China May Be Contaminated, FDA Says

    The US Food and Drug Administration (FDA) late Wednesday released a warning for drug compounders that certain lots of the active pharmaceutical ingredient (API) baclofen, manufactured by China’s Taizhou Xinyou Pharmaceutical & Chemical Co., may be at risk for contamination. “FDA contacted Taizhou through its US agent, and the company confirmed that, due to the level of controls in the manufacturing process, the baclofen API it manufactures is not suitable for use in inje...
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    FDA Warns Canadian API Manufacturer Following Adverse Event Reports

    After reports of serious adverse events surfaced for patients administered drug products compounded with an active pharmaceutical ingredient (API) from Quebec-based Medisca Pharmaceutique, the US Food and Drug Administration (FDA) inspected the company’s Pittsburgh-based site and found that the APIs were actually mislabeled and misbranded. During the inspection in February 2014, investigators collected six samples of APIs labeled as L-Citrulline that Medisca repackaged ...
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    FDA Warning Letter Details Serious Violations by another Indian API Manufacturer

    The US Food and Drug Administration (FDA) on Tuesday released another Warning Letter for an Active Pharmaceutical Ingredient (API) and drug manufacturer in India with a series of severe findings. The most recent letter sent to Gujarat, India-based Pan Drugs, which is already barred from supplying drugs and APIs to the US, follows the identification of more Current Good Manufacturing Practices (CGMP) violations by FDA inspectors, including data integrity issues, as well a...
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    API Manufacturer Warned by FDA Over Contamination, Data Integrity Issues

    A Czech manufacturer of active pharmaceutical ingredients (APIs) has been warned by the US Food and Drug Administration (FDA) for allegedly releasing products contaminated with bacteria. The company, VUAB Pharma of Roztoky, Czech Republic, was issued a Warning Letter by FDA on 27 May 2015 following a June 2014 inspection of the facility by FDA investigators that found "significant deviations from current good manufacturing practice (CGMP)." In one notable allegation, F...
  • Spain Launches new Registry of API Manufacturers, Distributors, Importers

    The Spanish Agency for Medicines and Health Products (AEMPS) has launched a registry of businesses involved in the manufacture, import and distribution of pharmaceutical active ingredients in Spain. The Unified Public Business Registry of Active Substance Businesses (RUESA) is part of the transposition of Directive 2011/62/EU , which addresses counterfeit drugs in the European Union and includes additional controls for active ingredients. The aim of the RUESA is to s...
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    FDA Wants to Make Product Recalls Easier to Track

    A little more than a month after first launching its long-anticipated openFDA project, the US Food and Drug Administration (FDA) has announced that it hopes the project can do for product recalls what it has already done for adverse event data. Background The openFDA initiative was born from a May 2012 order from the White House instructing federal agencies to begin implementing a new "digital strategy" aimed at making governmental information more readily available and...
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    Italian API Manufacturer Warned by FDA Over Missing Data

    An Italian active pharmaceutical ingredient (API) manufacturer has received a Warning Letter from the US Food and Drug Administration (FDA) chiding the company for allegedly deleting all of the data meant to ensure that its product was manufactured to specifications. The 15 July 2014 letter follows a January 2014 inspection of Trifarma S.p.A.'s manufacturing facility in Rozzano, Italy. There, FDA said its inspectors found several violations of its regulations on good ma...
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    FDA Launches Big Data 'openFDA' Initiative, Giving Public Easier Access to Safety Information

    The US Food and Drug Administration (FDA) has launched a long-awaited technology initiative intended to free regulatory data that was once difficult to obtain and harder still to make sense of. Background The initiative, known as openFDA, comes in the wake of a May 2012 order from the White House instructing federal agencies to begin implementing a new "digital strategy" aimed at making governmental information more readily available and accessible to the public....
  • Another Indian Pharmaceutical Company Hammered by FDA for Data Integrity Issues

    A new Warning Letter from the US Food and Drug Administration (FDA) has called out yet another Indian pharmaceutical manufacturing facility for allegedly tampering with or falsifying its data-the 10th letter to an Indian company in the last year making similar allegations. Background As  Regulatory Focus  has previously explained, FDA has been in the midst of a crackdown against deficient manufacturing practices in India, where inspectors have discovered glari...