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

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  • March 10, 2021

SOMERSET, NJ—Catalent has acquired Acorda’s dry powder inhaler (DPI) capsule manufacturing and packaging facility located in Chelsea, MA. The site features commercial- and clinical-scale DPI capsule manufacturing suites, including a PSD-7 spray dryer. This acquisition will expand the Catalent’s current capabilities, providing turnkey DPI solutions for initial development and device selection, capsule manufacture and packaging, […]

  • March 8, 2021

SILVER SPRING, MD—The FDA granted conditional approval of Laverdia-CA1 (verdinexor) tablets as a treatment for dogs with lymphoma. The drug prevents certain proteins from leaving the nucleus of cancer cells, allowing these proteins to control the growth and prevent the spread of cancerous cells in dogs. It is the first conditionally approved oral treatment for […]

  • March 7, 2021

ARLINGTON, VA—The International Pharmaceutical Excipients Council Federation (IPEC Federation) has published a revised edition of the IPEC General Glossary of Terms and Acronyms for Pharmaceutical Excipients. The glossary was originally published in 2014 and has been used to define excipient terms and acronyms commonly found in IPEC guides. The revised guide can be downloaded at […]

  • March 6, 2021

SILVER SPRING, MD—The FDA approved Lupkynis (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis. This is the first FDA-approved oral drug for the treatment of this condition. The product is manufactured by Aurinia Pharmaceuticals, Victoria, BC.

  • March 5, 2021

NORTH BETHESDA, MD—The International Society for Pharmaceutical Engineering (ISPE) has published the second edition of the ISPE Good Practice Guide: Maintenance, which describes the current established good practices and provides a practical and consistent interpretation of the required elements of a pharmaceutical maintenance program. The updated guide includes consolidated basic and good practices categories, added […]

  • March 4, 2021

SILVER SPRING, MD—The FDA approved an extended indication for Entresto (sacubitril/valsartan), making it the first and only approved therapy in the US to treat adult patients diagnosed with heart failure. This includes patients suffering from heart failure with reduced ejection fraction and heart failure with preserved ejection fraction. The approval of this expanded indication will […]

  • March 3, 2021

LISBON, Portugal—Hovione has launched a screening service for spray-dried dispersions called ASD-HIPROS. The platform is a tool for identifying optimal and commercially viable amorphous solid dispersion formulations by spray drying. Using an advanced computational tool, the platform is able to rapidly screen for the best combination of polymers, drug loads, surfactants, and solvents. This is […]

  • March 2, 2021

BRUSSELS, Belgium—ExciPact, an international non-profit organization that provides voluntary third-party GMP certification to excipient manufacturers, has certified JRS Pharma’s manufacturing site in Gujarat, India. The certification demonstrates that the site manufactures microcrystalline cellulose according to ExciPact’s GMP standards. Due to Covid-19 travel restrictions, these certificates offer customers risk assessment assurance without the need to travel.

  • March 1, 2021

BELFAST, UK—Sepha, a supplier of pharmaceutical packaging and machinery, has launched a contract packaging service at its Belfast facility to meet the rising demand for small-batch production in the pharmaceutical, nutraceutical, and medical device industries. The service aims to provide cost-effective, low volume runs of blister and medical device packs with short turnaround times. The […]