Pharma/Fine Chemicals Roundup – October 25
6:54 AM MDT | October 25, 2011 | By DEEPTI RAMESH
SALTIGO TO BUILD POTENT API FACILITY IN U.S.
Custom synthesis firm Saltigo (Langenfeld, Germany), a Lanxess subsidiary, says it will build new production capacities for potent active pharmaceutical ingredients (API) at its Redmond, WA site, to supply the American pharmaceutical industry.
Potent and highly potent APIs of categories III and IV as defined by the SafeBridge system already play a key role among the low-molecular-weight active ingredients, and this trend will continue to increase in the future, Saltigo says. Such substances can be administered in lower doses than other active ingredients and therefore generally cause fewer side-effects. On the other hand, their safe production and handling require specific precautions, Saltigo says.
“We have decided to expand the production capabilities at our Redmond site so that we can also produce and handle highly effective Category III substances there,” says Andreas Stolle, head of the Pharma business line at Saltigo. The respective capacities up to the kilogram range will become available at the beginning of 2012. The company will then also be able to produce active ingredients with an occupational exposure limit (OEL) of less than 10 micrograms per cubic meter of air. “Once the expansion project has been completed, we will be able to respond even more extensively and flexibly to our customers' requirements,” Stolle says.
Saltigo's services cover all the development stages for APIs, from the preclinical phase to the product's manufacture after-market launch. The production plants in Redmond are specifically oriented to the requirements during phases 1 and 2.
CARBOGEN AMCIS AND POLYMUN SIGN COLLABORATION AGREEMENT
Active pharmaceutical ingredient (API) producer and pharma process-development firm Carbogen Amcis (Bubendorf, Switzerland), a subsidiary of Dishman Pharmaceuticals & Chemicals (Ahmedabad, India), says it has signed a strategic alliance agreement with Polymun Scientific (Klosterneuburg, Austria). The agreement gives Carbogen Amcis access to Polymun’s innovative liposome technology for the formulation of APIs, while Polymun receives access to Carbogen Amcis’ expertise in the development and manufacture of highly potent APIs.
“We believe that our customers are interested in finding new ways to better deliver highly potent active ingredients. This alliance expands our portfolio of offerings and moves us one step closer to achieving this goal,” says Mark Griffiths, CEO of Carbogen Amcis. “Carbogen Amcis and Polymun look forward to combining both companies’ strengths to offer our customers new cost-effective solutions for liposomal formulation of highly potent drugs.”
The agreement with Carbogen Amcis provides Polymun with a reliable partner for the handling of highly potent APIs and allows Polymun to expand its service offerings to cytotoxics and cytostatics.
Polymun Scientific is a private company founded in 1992 and it offers contract development and manufacturing services for biopharmaceuticals, using both mammalian and microbial cell technology. In addition, the company offers innovative liposome technology for the formulation of pharmaceutically active ingredients and vaccine antigens.
ALMAC TO EXPAND API CAPACITY IN U.K.
Almac (Craigavon, U.K.) says it is expanding its active pharmaceutical ingredient (API) manufacturing capacity at Craigavon, in response to increasing demand. Almac is expanding manufacturing capacity at the Craigavon site to over 30m3 and the upgraded facility will include reactor vessels with clean room product isolation and drying equipment to allow highly potent API manufacture up to 600 kg batch size. It is anticipated that the expanded facility will become operational within the next two years.
Almac provides a range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply, to commercial-scale manufacture. With currently six API and advanced chiral intermediates in Phase III clinical development, Almac has steadily increased its market penetration in late phase clinical development, leveraging its API and drug product integrated offering, Almac says.
“This capacity increase will allow a smooth transition from late phase clinical development to full commercialization,” says Denis Geffroy, v.p./business development. “Scale was becoming a limiting factor for some of our client projects and this new capacity is a strong commitment to offer project continuity. It opens up a new chapter in Almac’s API manufacturing capability.”
MYLAN REBRANDS INDIAN API SUBSIDIARY
Mylan (Canonsburg, PA) says that its Matrix Laboratories (Hyderabad, India) subsidiary has formally changed its name to Mylan Laboratories. Matrix is one of the world's largest suppliers of active pharmaceutical ingredients (API). Mylan acquired a majority stake in Matrix in 2007, and in 2009, Mylan purchased the stake in Matrix that it did not already own from minority shareholders.
“We are pleased to complete the name change from Matrix to a Mylan company and are excited to operate in India under one powerful brand,” says Robert J. Coury, chairman and CEO of Mylan. Mylan plans to further educate “customers, physicians, pharmacists and patients about the Mylan brand as we continue to grow our existing business and launch in the Indian commercial market in the coming months.”
Matrix has a range of products, including those in the anti-asthmatic, antibacterial, antifungal, antiretroviral (ARV), cardiovascular, CNS, gastrointestinal and pain management segments, and it also offers a growing line of finished dosage form products, predominantly generic ARV therapies.
AMRI APPOINTS NEW HEAD OF API OPERATIONS IN INDIA
Albany Molecular Research Inc. (AMRI; Albany, NY) says that Subramanyam Maddala has been appointed president of India Operations, and he will lead AMRI's Indian active pharmaceutical ingredient (API) manufacturing operations and AMRI facility operations at Hyderabad and Aurangabad, in India.
The appointment of Subramanyam Maddala will “take AMRI's chemical manufacturing business in India to the next level, including the capability to eventually manufacture multiple products in India to U.S. FDA standards,” says Steven Hagen, v.p./pharmaceutical development and manufacturing at AMRI.
Subramanyam Maddala has over 20 years of operations, business development, and senior leadership experience in the manufacturing of APIs and intermediates, custom synthesis, and formulations in branded and generics markets. Most recently, he served as v.p./contract research and manufacturing services and new generics for Shasun Pharmaceuticals.
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