Industry Briefs: March 18, 2013

The CDMO DPT Laboratories received notification from FDA on Feb. 19, 2013, that signaled the completion of the agency’s evaluation of DPT’s corrective actions taken at its Lakewood, New Jersey, facility in response to a Warning Letter received on Aug. 27, 2012. In addition, the letter communicated that in the view of FDA, the Lakewood site is compliant with FDA regulations. Read More (PDF)

The International Pharmaceutical Excipients Council of the Americas (IPEC-Americas) has published the 2013 Excipient Information Package User Guide, which is now available for free download from the IPEC-Americas website. The revised guide updates the originally published 2005 version and can be used by excipient suppliers to provide a standardized set of documents to exchange data between suppliers and their customers. The Excipient Information Package (EIP) is set up similar to a Material Safety Data Sheet (MSDS) with designated sections to include specified data on specific topics. The guide is intended to assist individuals experienced in evaluating excipient suppliers but is not a replacement for audits. Read More

Micromeritics recently published its March 2013 microReport eNewsletter edition highlighting products, services, applications information, and upcoming events. New products include the 3Flex Surface Characterization Analyzer and Particluate Systems’ NanoPlus DLS Nano Particle Size and Zeta Potential Analyzer. The 3Flex is a versatile high-throughput surface area, mesopore, and micropore system. A single 3Flex with its three configurable analysis stations eliminates costly investment in multiple instruments and additional bench space. Heated vapor analysis capability is standard and an extended-range vapor option is available. The NanoPlus utilizes photon correlation spectroscopy and electrophoretic light scattering techniques to determine particle size and zeta potential. Micromeritics showcased these instruments, as well as many other products, at Pittcon 2013 in Philadelphia, Mar. 17–21, 2013. Application articles include: “Carbon Dioxide Characterization of Carbons with the TriStar II 3020,” “Particle Characterization Solutions for the Appearance and Structure Assessment of Lyophilized Biopharmaceutical Compounds,” and “Physical Characterization of Shale.” The new microReport also includes a list of upcoming scheduled events as well as instrument and analytical technique courses offered by Micromeritics’ Learning Center. Read More (PDF)

The CMO Neuland Laboratories has formed a manufacturing collaboration with Tokyo-based API Corporation (APIC), a healthcare unit of Mitsubishi Chemical Holdings Group that produces APIs, intermediates, investigational new drugs, fine chemicals, and reagents. Under the agreement, API Corporation is making an investment in Neuland’s facilities that will provide APIC with dedicated capacity for meeting the needs of its customers. The facilities will be operated by Neuland’s employees and the two companies will share oversight and management responsibilities. Read More (PDF)