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

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Posted October 3, 2019

DANIA BEACH, FL–CapsCanada relocated its headquarters to a 130,000-square-foot facility at Dania Beach, FL. This move increases the company’s capability to supply tis K-Caps vegetarian capsules. The new headquarters is located at 3236 SW 30th Ave, Dania Beach, FL, 33312.

Posted September 24, 2019

SILVER SPRING, MD—The FDA proposed an amendment to its 503A Bulks List regulations to add five substances to the list of bulk drug substances (APIs) that can be used in compounding although they are neither the subject of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph nor components of FDA-approved drugs. The proposed amendment also identifies 26 bulk drug substances that the FDA has considered and proposes not to include on the list.

Posted September 24, 2019

THOUSAND OAKS, CA—Amgen, a California-based biopharmaceutical company, has acquired the worldwide rights to Otezla (apremilast) from Celegene, Summit, NJ. Otezla is the only oral, non-biologic treatment for psoriasis and psoriatic arthritis. The acquisition is a result of Celegene’s impending merger with Bristol-Myers Squibb, New York, NY.

Posted September 24, 2019

AMSTERDAM, Netherlands—The European Medicines Agency (EMA) and the FDA agree on more than 90 percent of marketing authorization decisions for new medicines, according to a joint EMA/FDA analysis. The analysis compared the two agencies’ decisions on 107 new medicine applications from 2014 to 2016. In the 10 percent of cases where the agencies disagreed on an authorization decision, the cause was either differing conclusions on drug efficacy or differences in in the clinical data submitted. This is the first analysis by EMA and the FDA that compares the agencies’ decisions on marketing authorizations.

Posted September 24, 2019

DUBLIN, Ireland—PCI Services has invested in a 75,000-square-foot clinical facility near Dublin that will increase the company’s capabilities and capacity as well as serve as a center for primary and secondary packaging, storage, logistics, and distribution. The expansion will include additional controlled room temperature and cold chain storage capabilities as well as clinical packaging services. The facility also offers clinical storage and distribution for the shipment of investigational medicinal products to sites based within the EU and around the world.

Posted September 24, 2019

SOMERSET, NJ—Catalent, a pharmaceutical CDMO, will invest $9 million in a new clinical supply facility in San Diego, CA, that is scheduled to open in the summer of 2020. The 24,257 square-foot facility will specialize in services for early-phase clinical trials and offer full clinical supply services to pharmaceutical and biopharmaceutical clients. Site capabilities will include clinical supply management, primary and secondary packaging, complex labeling services, clinical storage, distribution, drug returns and destruction, and stability chambers.