Spotlight On... Consent decree issued against recalcitrant compounder; Aurobindo to build plant in Saudi Arabia; U.K.'s Cell Therapy Catapult works on viral vector manufacturing; and more...

The FDA has secured a consent decree against a Texas compounder that had questioned FDA authority over its operations. The FDA says that a federal judge issued the consent decree last week against Downing Labs of Dallas, co-owners Ashley Michelle Downing and Christopher Van Downing, and pharmacist-in-charge Roger Mansfield. Downing Labs, formerly known as NuVision Pharmacy, had continued to manufacture adulterated drugs even after repeated warnings from the FDA, the regulator said. The compounder, which had resisted FDA pressure to recall all of its sterile drugs, finally relented last fall. Release | More

> Saudi Arabia, which has been recruiting companies to open drug manufacturing facilities, says India's Aurobindo will the next to build a plant there. Release

> The Cell Therapy Catapult in England said that it is working with Synpromics on a project it hopes will speed viral vector manufacturing for the development of cell and gene therapy drug production. Report

> Eagle Pharmaceuticals says it will work with CMO AMRI ($AMRI) to develop and manufacture several complex parenteral drug products for the U.S. market. Report

Suggested Articles

The FDA has slapped the parent of Dollar Tree stores with a warning letter saying some CMOs that made its OTC products were among the world's worst.

GSK expects Shingrix supplies to rise slightly in 2020, but the real "step change" will come in 2024 with a brand-new manufacturing facility.

Continuing its expansion efforts, Japan’s Fujifilm will make a major investment in its U.S. gene therapy operation in Texas.