Pharma manufacturing news in brief
pharmafile | April 26, 2011 | News story | Manufacturing and Production | Archer Daniels Midland, Dow Chemical, IPEC Americas, Pharmatek Laboratories, Taro, Taro Pharmaceutical Industries, Teva, Teva Pharmaceutical Industries, manufacturing, manufacturing news in brief, pharma manufacturing news
Includes a formulation problem for Teva, facility updates from Taro and ADM, and a new excipient screening initiative at the FDA.
Teva Pharmaceutical Industries has taken its ODT (orally-disintegrating tablet) formulation of lansoprazole off the market after receiving reports that it blocked oral syringes and feeding tubes. The FDA said it was concerned that a failure to fully disintegrate – or the re-aggregation of an already-dissolved dose – could lead to patient harm. Around 10% of patients receiving lansoprazole ODT do so through a syringe or feeding tube, according to Teva.
IPEC Americas, an industry body represent excipient suppliers, has agreed to collaborate with the FDA on the development of a comprehensive library of pharmaceutical excipient samples to help the US regulator monitor raw materials and finished products through rapid screening techniques. The overall aim is to identify materials in need of more in-depth analysis and to prevent counterfeit, contaminated and mislabelled substances from entering the market and causing harm.
Taro Pharmaceutical Industries says it has resolved all the GMP violations at its facility in Brampton, Canada, which were cited by the FDA in a February 2009 warning letter. The agency had uncovered several problems at the plant, including stability and purity failures for various creams and ointments, including betamethasone, fluocinonide, hydrocortisone and ciclopirox products. The Israeli drugmaker, in which India’s Sun Pharma took a majority stake last year after a drawn-out and acrimonious battle, had been blocked from seeking regulatory approval for products made at the plant until the violations were addressed.
Archer Daniels Midland (ADM) has started industrial-grade production of bio-based propylene glycol – made at its facility in Decatur, Illinois, and says it will refine the process to produce material that meets US Pharmacopeia (USP) standards over the course of the coming months. The plant makes propylene glycol from glycerol, which in turn is a by-product of the production of biodiesel from vegetable oils. The process is a simple chemical reaction that uses no environmentally harmful chemicals and uses only water for solvent.
Pharmatek Laboratories has been given a green light by the US Drug Enforcement Agency to carry out analysis of Schedule I to IV controlled substances. The approval allows the development and manufacturing service specialist to perform analytical and stability testing of controlled-substance drug products in its non-potent and high-potency GMP plants. Pharmatek already has a license to develop and manufacture products containing Schedule IV and V substances.
Dow Chemical has successfully passed a certification audit for a new pharmaceutical excipient – Dow PuraGuard (propylene glycol) – indicating that its manufacturing facilities in Louisiana and Texas are operating to GMP standards. The certification was carried out by International Pharmaceutical Excipients Auditing (IPEA), a commercial group which audits facilities to check they conform to GMP principles developed by the International Pharmaceutical Excipients Council (IPEC) and Pharmaceutical Quality Group (PQG).
Phil Taylor
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