Enteris BioPharma, which was formed in August 2013, will offer contract manufacturing after investing about $1 million into its 32,000-square-foot, FDA-approved manufacturing plant where it makes active pharmaceutical ingredients (APIs) up to commercial scale using microbial expression systems.
India's Piramal Enterprises said it was on the cusp of buying a CDMO founded at the University of Kentucky. That comes weeks after Japan's Fujifilm Diosynth Biotechnologies bought half of a vaccine manufacturing specialist from the Texas A&M University System.
California-based Peregrine Pharmaceuticals says that contract manufacturing revenue was off in its last quarter but demand remains high for its Avid Bioservices unit, and so like a number of contract manufacturers that target biologics, it is adding capacity.
Grand River Aseptic Manufacturing (GRAM), a small parenteral contract manufacturing company in Grand Rapids, MI, has opened a new 28,000-square-foot facility for its finishing operations, inspection services and storage, as well as housing a substantially larger lab, Contract Pharma reports.
Cubist is going through a bad patch with outsourced production. The problems began in August 2013, when CMO quality failings prompted Cubist to recall four lots of its injectable antibiotic Cubicin. Having summoned back another lot in April, Cubist has now issued a much larger recall, with about 100 lots affected.
Contract services company Aptuit will invest $1 million in its facility in Glasgow, Scotland, to expand its capacity to manufacture sterile cytotoxic liquid and lyophilized drug products.
While geopolitical instability in Eastern Europe would appear to make Russia a risky bet, the size of the market and incoming targets on drug production mean the likes of Abbott Laboratories are still investing. For companies unwilling or unable to strike deals like Abbott's $495 million buyout of Veropharm, a new option is tipped to emerge: CMOs.
California contract manufacturer Laclede was warned. Now it is being legally stormed. After years of letters, inspections and meetings with the FDA couldn't move the company to seek an NDA for its vaginal gel products, the FDA has sued Laclede to get it to stop making them.
A new company, initially dubbed NewCo and created by the $2.6 billion merger of contract manufacturer Patheon and Netherlands-based DSM Pharmaceutical Products, has officially broken onto the scene. It has been given the moniker of DPx and starts its corporate life as one of the largest contract manufacturing and development groups in the world.
A voluntary recall was issued Friday after there was a report of a single visible glass particle in a vial in a lot that was produced for Genco Pharmaceutical Services.