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Pharma/fine chemicals roundup—15 April 2014
3:42 AM MDT | April 15, 2014 | By DEEPTI RAMESH
Mitsubishi Chemical subsidiary and Neuland open pharma ingredients plant in India
Neuland Laboratories (Hyderabad, India), a pharmaceutical manufacturer that provides active pharmaceutical ingredients (APIs), complex intermediates, and contract manufacturing services, says that it has opened a new manufacturing facility at Hyderabad, constructed as part of its previously announced collaboration with API Corp. (Tokyo), a subsidiary of Mitsubishi Chemical Holdings that produces APIs, intermediates, and investigational new drugs, along with fine chemicals and reagents. Mitsubishi Chemical Holdings is the parent of Mitsubishi Chemical.
Neuland and API Corp. entered into a manufacturing collaboration in March 2013. API Corp., under the deal, invested in Neuland’s new facility that will provide API Corp. with dedicated capacity for meeting the needs of its customers for APIs and pharmaceutical intermediates. The facility will be operated by Neuland, and the two companies will share oversight and management responsibilities. The new facility, which is located at a Neuland manufacturing complex at Hyderabad, is the first manufacturing facility that API Corp. has established outside of Japan.
FDA warns consumers not to use weight-loss drug product because of harmful API
FDA has warned consumers to immediately stop using Zi Xiu Tang Bee Pollen, marketed as a product for weight loss and body reshaping. The product contains at least one potentially harmful active pharmaceutical ingredient that is not listed on the product’s label, FDA says. FDA says it has received dozens of adverse event reports, including many serious cardiac issues, associated with the use of Zi Xiu Tang Bee Pollen. Zi Xiu Tang Bee Pollen is manufactured by Guangzhou Zi Xiu Tang Biotechnology in Guangdong Province, China. The drug is offered for sale on the internet and can be found in various retail stores, spas, and fitness centers. In addition, licensed health-care professionals have promoted the product.
FDA has tested multiple Zi Xiu Tang Bee Pollen products from various distributors in the United States. All products that have been tested have been found to contain one or both of the undeclared drug ingredients—sibutramine and phenolphthalein. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke, FDA says. Phenolphthalein is not an active ingredient in any approved drug in the United States, Studies have indicated that it presents a cancer-causing risk, FDA says. The agency is investigating the distribution of Zi Xiu Tang Bee Pollen products in the United States and may issue warning letters or take enforcement action, such as seizures, injunctions, and/or criminal charges.
Aesica-led consortium wins grant for sustainable high-value chemical manufacturing
Aesica Pharmaceuticals (Newcastle, UK) says it has led a consortium, also comprising Charnwood Technical Consulting, CatScI, and Biocatalysts, that has won a Technology Strategy Board (Swindon, UK) grant directed at funding sustainable, high-value chemical manufacturing achieved through industrial biotechnology. The Technology Strategy Board is the United Kingdom's innovation agency. The winning project is focused on establishing an industrial biotechnology process aimed at improving the sustainability of the manufacture of an active pharmaceutical ingredient (API), Aesica says. The grant is designed both to assist commercial entities in testing new processes and to create demonstration scale prototypes. The project is scheduled for completion later this year.
Biocatalysts will use design for manufacture principles to discover, develop, and manufacture novel enzymes for the production of APIs. CatScI will perform the proof of concept studies to assess the feasibility of a value-adding novel industrial biotechnology route to an API. Charnwood will provide expertise to help design and scale up the process as well as guidance on quality and regulatory issues. Aesica will manage the overall project and carry out scale-up studies to determine the feasibility of the technology at larger scale.
Excipact signs deal with AJA Registrar Germany to audit pharmaceutical excipient suppliers
Excipact says that it has signed an agreement with AJA Registrars Germany, an internationally recognized certifying body, for the certification of the manufacture and distribution of pharmaceutical excipients according to the Excipact GMPs and good distribution practices certification standards. AJA auditors will become certified auditors under the Excipact certification scheme. Excipact, which was a project of the IPEC Federation (Brussels), became a free-standing, not-for-profit company at the end of January.
Lonza and Amyra sign development and manufacturing agreement
Lonza and Amyra Biotech (Zug, Switzerland), a biotech company developing novel enzyme-based treatments for Celiac disease—gluten intolerance—has signed an agreement to develop and manufacture Amyra’s two proprietary enzymes targeting gluten. Lonza, under the agreement, will produce material at its microbial manufacturing facility at Kourim, Czech Republic. The XS commercial license provides access to Lonza’s multihost XS microbial expression technology platform. “The collaboration between Amyra and Lonza ... began in the early stage of expression system development and is now moving into large-scale process development,” says Janet White, head/custom development services at Lonza.
Technip awarded contract for Cargill’s ethanol plant in Germany
Technip says it has been awarded a contract comprising detailed engineering, procurement, and construction for the core process units of Cargill’s new ethanol production plant at Barby, Germany. The production units will be built on a greenfield site alongside Cargill’s existing wheat-processing facility. Technip's operating center at Düsseldorf will execute the contract, which is scheduled to be completed by the second half of 2015. Cargill announced last December that it will invest €60 million ($83 million) in the ethanol plant at Barby, and the ethanol will be used for the beverage, cosmetics, and pharmaceutical industries.
Beyond IHS Chemical Week:
Canton Labs hit with US FDA import alert at Indian API plant
FDA has banned imports of drug products made at Canton Laboratories’ Baroda, India, plant weeks after the plant was pulled up for data failures.