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Pharma/fine chemicals roundup—29 October 2013
7:22 AM MDT | October 29, 2013 | By DEEPTI RAMESH
American Capital to invest $391 million in the combination of Cambridge Major and AAIPharma
Private equity firm American Capital (Bethesda, MD) says that it has committed $391 million to the combination of its portfolio company Cambridge Major Laboratories (CML; Germantown, WI) with AAIPharma Services Corp. (Wilmington, NC), provider of analytical and formulation services that support all phases of drug development, and the related recapitalization of the business. CML is a provider of complex chemistry-based outsourcing services and active pharmaceutical ingredient (API) manufacturing services to the pharmaceutical and biotechnology industries. On 2 October, CML and AAIPharma Services announced they would merge in a deal expected to close by the end of October. American Capital's investment is comprised of a revolving credit facility, senior term loan and common and preferred equity. CML was acquired by American Capital for $212 million late last year.
Albemarle expands API plant in Michigan
Albemarle says it will expand its active pharmaceutical ingredient (API) operations at South Haven, MI. The expansion of the plant’s kilo lab will help the company meet customer needs for the entire API life cycle, from testing through commercial production, Albemarle says. The expanded kilo lab will be operational in January 2014.
Evonik improves process, lowers price for L-ornithine L-aspartate
Evonik Industries says that it has improved its production process for L-ornithine L-aspartate (LOLA), an active ingredient used in pharmaceuticals. The company says that it has improved the process, which is based on production of L-ornithine by fermentation and biocatalytic production of L-aspartate, at every stage. The new process leads to crystals of particularly high purity with higher stability, Evonik says. The company announced a price reduction of 5–10% in LOLA at the CPhI trade show in Frankfurt, Germany, last week.
Asahi Kasei establishes pharmaceutical research complex
Asahi Kasei says its Asahi Kasei Pharma unit has completed the construction of a new research complex in its Pharmaceuticals Research Center at Shizuoka, Japan, and the complex became operational on 25 October. The new complex brings the previously separated synthetic and medicinal chemistry research group and pharmacology research group together in a single shared facility for closer coordination. The newly complex, which employs about 150 people, provides Asahi Kasei Pharma with an enhanced infrastructure for more effective pharmaceutical research focused on the creation of new drugs, Asahi says. Asahi Kasei Pharma will also construct an animal experiment annex attached to the new complex, with groundbreaking scheduled for May 2014 and operations to begin in April 2015.
Evonik API site in China receives written confirmation of EU GMP compliance
Evonik Industries says that it was one of the first active pharmaceutical ingredient (API)–producing companies in China to be granted written confirmations by the Guangxi Food and Drug Administration for all products manufactured at the company's site at Wuming, China. These confirmations certify that the facility operates in accordance with EU GMP requirements. As of 2 July, the compliance of APIs manufactured outside and imported into the EU must be confirmed in writing by a competent authority of the exporting country. This document must also confirm that the plant where the API was manufactured is subject to control and enforcement of GMP at least equivalent to that in the European Union. The written confirmations enable Evonik to continue exporting APIs from China to Europe under new EU legislation, the Falsified Medicines Directive.
DSM appoints new head of biopharm businesses
DSM says it has appointed Manja Bouman as president and business unit director of biopharm businesses at DSM Pharmaceutical Products. Bouman now heads the DSM Biologics and DSM BioSolutions businesses within DSM Pharmaceutical Products. Bouman reports to Lukas Utiger, president and CEO of DSM Pharmaceutical Products. Bouman was most recently CEO of Regenesance. With operations at Groningen, the Netherlands and at Brisbane, Australia, DSM Biologics specializes in preclinical through commercial biomanufacturing of recombinant proteins and monoclonal antibodies based on mammalian cell cultures. DSM BioSolutions offers large-scale fermentation for large and small molecule active pharmaceutical ingredients for therapeutic proteins and enzymes at DSM’s Capua, Italy site, with support from the DSM Biotechnology Center at Delft, the Netherlands.
Brenntag opens life sciences facility in Spain
Brenntag (Mülheim, Germany) has inaugurated a new facility at Granollers, Spain, dedicated to the food, pharmaceutical, and cosmetics industries. The facility offers specialized storage vessels, mixing and blending facilities, an application laboratory, as well as a white room for the packaging of pharmaceutical products within a controlled atmosphere. Details pertaining to the size of the investment have not been disclosed.
Shasun Pharma UK plant inspected by MHRA
Shasun Pharmaceuticals (Chennai, India) says that the Medicines and Healthcare Products Regulatory Agency (MHRA) had completed an inspection of its manufacturing facility at Dudley, UK, during the third week of October. The main focus of the inspection was to conduct a cGMP audit for its UK contract research and health-care services (CRAMs) Shasun Pharma Solutions facility.