Pharma/fine chemicals roundup—8 October 2013
6:48 AM MDT | October 8, 2013 | By DEEPTI RAMESH
Cambridge Major Laboratories and AAIPharma to merge
Cambridge Major Laboratories (CML; Germantown, WI), a producer of pharmaceutical intermediates and active pharmaceutical ingredients (APIs); and AAIPharma Services Corp. (Wilmington, NC), a provider of pharmaceutical analytical testing, product development, and manufacturing services, say that they intend to merge to form the premier global supplier of integrated chemistry, manufacturing, and controls (CMC) services. Financial terms of the merger were not disclosed. The merger is expected to close by the end of this month.
Carbogen Amcis invests in ADC capabilities
Carbogen Amcis (Bubendorf, Switzerland), a pharma process-development and active pharmaceutical ingredient (API) manufacturing subsidiary of Dishman Pharmaceuticals and Chemicals (Ahmedabad, India) says it is investing to enhance its antibody drug conjugate (ADC) capabilities in order to better respond to increasing demand for ADCs in the development of highly targeted cancer treatments. The investments include a $4-million clean room clinical supply facility at the Bubendorf site and nearly a $1-million upgrade of the sterile manufacturing area in the facility at Riom, France.
First FDA warning letter for nonpayment of GDUFA fee issued against German manufacturer
The US FDA has issued a warning letter to C.P.M. ContractPharma (Feldkirchen-Westerham, Germany), a contract manufacturing firm, for failing to self identify and pay its annual fee, as required under the FDA’s Generic Drug User Fee Amendments of 2012 (GDUFA). The facility has been placed on a publicly available arrears list, FDA says. “Failure to correct these violations promptly may result in regulatory action, including seizure or injunction without further notice; and the facility may also be placed on import alert such that any drug the facility manufactures will be refused admission into the United States,” FDA says. This is the first such warning letter issued by the FDA for nonpayment of GDUFA facility fee.
PCI Synthesis appoints new v.p./business development
PCI Synthesis (Newburyport, MA), a custom chemical manufacturer of new chemical entities (NCE), generic active pharmaceutical ingredients (APIs), complex pharmaceutical intermediates, and other specialty products, says it has appointed Glenn Killingworth as v.p./business development. A specialist in the field of organic chemistry, Killingworth brings 25 years of experience working for specialist companies, including former Fisher Scientific, Peakdale Molecular (High Peak, UK), Almac Sciences (Craigavon, UK), WuXi Apptec (Shanghai), and Asymchem (Morrisville, NC), PCI says. Killingworth has spent the last decade in commercial and business development roles, developing a proven track record of sales achievements principally in the pharmaceutical R&D sector worldwide, PCI says.
Report: American Pacific considering sale?
American Pacific (Las Vegas), the parent company of Ampac Fine Chemicals, is considering a sale of the whole company, according to a Reuters report. KeyBanc (Cleveland) is reportedly advising American Pacific on the matter, although the report did not mention any potential buyers.
Jubilant consolidates pharma business under Singapore subsidiary
Jubilant Life Sciences (Noida, India) says its board of directors voted to transfer the active pharmaceutical ingredients (APIs), dosage forms business, and the 18% shareholding held by Jubilant in Jubilant Pharma Holding, and the 77.65% shares in Belgium-based Jubilant Pharma NV to a new company to be incorporated in India as a wholly owned subsidiary of Jubilant Pharma Ltd. Singapore, which is a wholly owned subsidiary of Jubilant.
Actavis completes $8.5-billion Warner Chilcott acquisition
Actavis (Parsippany, NJ) says it has completed the previously announced acquisition of Warner Chilcott (Dublin) in a stock-for-stock transaction valued at about $8.5 billion. The combination creates a leading global specialty pharmaceutical company with about $11 billion in anticipated pro forma combined annual 2013 revenue, and the third-largest specialty pharmaceutical business in the United States with about $3 billion in annual revenue focused on the core therapeutic categories of women's health, urology, gastroenterology and dermatology.
IMCD opens its first pharmaceutical laboratory
Specialty chemicals and food ingredients distributor IMCD Group (Rotterdam) says that it has opened a new pharmaceutical laboratory at Huerth near Cologne, Germany. The IMCD Pharmaceutical Technical Centre (PTC) will focus on training and market support throughout Europe. PTC, by the end of 2013, will be equipped to support activities for solid-dose development, tablet-coating and the development of suspensions and syrups, IMCD says. “Strategically located in the heart of Europe, this new laboratory allows us to greatly enhance our internal training and technical support for the rapidly expanding number of projects we are involved with,” says Alen Guy, technical director at IMCD Pharma.
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