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The only technical publication dedicated to readers who formulate, manufacture, or package solid dosage forms.

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Posted June 19, 2019

NORTHBROOK, IL—The Latin American pharmaceutical excipients market is projected to reach $579 billion by 2024, growing at a compound annual rate of 7.5 percent, according to a report by Markets and Markets. Elements driving growth in this region include the growing pharmaceutical industry in Latin American countries such as Brazil, Mexico, and Argentina; multinational corporations’ increasing focus on investing in the Latin American pharmaceutical and healthcare sectors; a rapidly growing aging population and the subsequent increase in the prevalence of related diseases; and local and government funding for R&D activities. The report identifies DowDuPont, Roquette, Ashland, BASF, and Kerry as major players in the Latin American pharmaceutical excipient market.

Posted June 18, 2019

ARLINGTON HEIGHTS, IL—In the last five years, the number of US allergists prescribing sublingual immunotherapy (SLIT) tablets rather than the more traditional allergy shots has grown, according to a study published by the American College of Allergy, Asthma, and Immunology (ACAAI) Immunotherapy and Diagnostics committee. The organization sent out an electronic survey to US and international allergists who are also ACAAI members and compared the results with previous surveys conducted and published in 2007 and 2011. Of the 305 respondents, 268 (87.9 percent) practiced in the US and of those 268 US allergists, 197 (73.5 percent) reported prescribing SLIT to patients, showing a significant increase compared to the 2007 (5.9 percent) and 2011 (11.4 percent) surveys. This growing use of SLIT prescriptions may have been driven by four recent FDA-approved SLIT options.

Posted June 17, 2019

ARLINGTON, VA— The IPEC Federation has published a position paper on supply chain security for pharmaceutical grade excipients to provide support to excipient manufacturers, distributors, pharmaceutical traders, brokers, carriers, and other service providers along the supply chain. The paper summarizes existing regulations and tools that support good practices for supply chain security and drug safety, including IPEC’s Good Distribution Practices Guide for Pharmaceutical Excipients and its Risk Assessment Guide. While the federation emphasizes that supply chain responsibility ultimately remains with the finished dosage form manufacturer, each participant in the supply chain, both up and downstream, has responsibilities for its own specific area of activity.

Posted June 17, 2019

SILVER SPRING, MD—The FDA published the final guidance “Determining Whether to Submit an ANDA or 505(b)(2) Application,” which focuses on the application criteria for abbreviated approval pathways under section 505(j) and section 505(b)(2) of the Federal Food, Drug, & Cosmetic Act. This guidance is intended to help manufacturers determine which of the two pathways is most appropriate for submission of a marketing application for a human drug product and provides applicants with direction on requesting assistance in making this determination as well as regulatory and scientific considerations for ANDA and 505(b)(2) applications.

Posted June 17, 2019

MEXICO CITY, Mexico—Jorge Martinez Garibay has been named Expo Pack general director at PMMI’s office in Mexico City, Mexico. Garibay will direct the sales, marketing, operations, and public relations efforts of Expo Pack México and Expo Pack Guadalajara.

Posted June 17, 2019

COBOURG, ON,—Lorenz Conveying Products, hired Chris Robinson as its US sales manager. Robinson will be responsible for sales, representative sales groups, and key accounts in the US.

Posted June 17, 2019

CHARLES CITY, IA —Cambrex, a CDMO specializing in small molecules, completed the construction of a $24 million highly potent API (HPAPI) manufacturing facility at its Iowa site. The 6,000-square-foot facility has been validated and has begun work on customer projects. The site now has the flexibility to support all phases of development and offer all scales of HPAPI manufacture across the full occupational exposure limit (OEL) band spectrum.

Posted June 17, 2019

NOTTINGHAM, UK—I Holland, a tooling supplier, launched an online learning program that offers professionals comprehensive and flexible courses including modules on introduction to tablet tooling, tooling maintenance, troubleshooting production problems, and improving productivity. Courses give training managers and supervisors a full audit, tracking, and reporting of employee development and certification. All courses can be accessed on desktop computers or mobile devices, allowing employees to access education and updates on best industry practices and tablet tooling developments.

Posted June 17, 2019

EBERBACH, Germany—Catalent, will expand its integrated turnkey softgel capabilities at its facility in Eberbach, Germany. The $14 million investment will allow the company to install two new softgel encapsulation lines dedicated to manufacturing its Vegicaps plant-based softgels along with printing and vision inspection systems and expand its softgel coating and packaging capacities. The company anticipates completing the expansion by mid-2020 and has already increased total production output by growing its workforce by more than 10 percent across operations, quality control, and related supporting functions.

Posted June 17, 2019

HARLEYSVILLE, PA—Colorcon, a pharmaceutical coating provider, and DuPont Nutrition & Biosciences have agreed to add the Aquacoat modified-release coating products to their Controlled Release (CR) Alliance portfolio. The alliance grants Colorcon exclusive global distribution rights for certain Dow products to serve the needs of the pharmaceutical industry, providing customized solutions, products, and support services for pharmaceutical product development. The Aquacoat product line includes ECD for sustained release and CPD for enteric-coating applications. These aqueous functional coatings are designed for use in both pharmaceutical and nutritional solid dose applications.

Posted June 17, 2019

WINCHESTER, KY—Catalent, a provider of delivery technologies and development solutions for drugs, biologics, and consumer health products, will invest up to $40 million to expand its Kentucky manufacturing facility. The expansion will include new equipment that will increase the site’s capacity and its formulation and controlled-release tablet and capsule manufacturing capabilities. The installation of a spray dryer will provide commercial scale up capacity for projects that progress from early stage development and allow tech transfer of projects from the company’s development sites in San Diego, CA, and Nottingham, UK.