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2006.10.23
EFCG and SOCMA Urge More Inspection of Foreign API Makers
Date: 2006.10.12 Pharmaceutical Technology. CPhI Worldwide, Paris (Oct. 3, 2006)—The Synthetic Organic Chemical Manufacturers Association (SOCMA, Washington, DC, www.socma.org) and the European Fine Chemicals Group (EFCG, Brussels, www.efcg.cefic.org) have teamed to urge US and European regulatory authorities to increase inspections of foreign manufacturing facilities of active pharmaceutical ingredients (APIs) to reduce patient risk from sub-par drugs, to increase national security, and to level the economic playing field
2006.10.23
EFCG and SOCMA Urge GMPs for APIs
Date: 2006.10.03 Description: Pharma & Bio Ingredients. The European Union and the United States both have rules in place to ensure that active pharmaceutical ingredients – or APIs – used in the manufacturing of medicines meet the pharmaceutical industry’s accepted current good manufacturing practices (GMP). However, the U.S. Food & Drug Administration (FDA) and the European Union equivalent agencies do not inspect all foreign facilities manufacturing APIs serving them. According to a 1999 FDA report, 242 manufacturers imported in the United States without being inspected, these points were spelled out at a recent press conference held Oct. 3 at CPhI in Paris.
2006.10.23
Panama recalls medicine after mystery deaths
Date: 2006.10.08 Description: PANAMA CITY (Reuters, 2006.10.08) - Panamanian authorities recalled a popular high blood pressure medicine after investigations linked it to a mystery illness that has killed 19 people. Health Minister Camilo Alleyne said on Saturday early tests on Lisinopril tablets had not detected toxic agents, but the drug was being recalled from pharmacies, hospitals and private clinics nationally as a precaution.
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