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.
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.
There is more movement in the active pharmaceutical ingredient manufacturing market, this time in France, where peptide specialist Synprosis was snapped up by fine chemical maker Provence Technologies Group.
Over the past decade patent expiries have forced many Big Pharma to close production plants that supported decades of growth. With the current and next generations of small molecules and biologics raising the bar for manufacturing complexity, Eli Lilly, Merck and their peers face a choice: build plants or outsource?
A slide in contract manufacturing undermined earnings for India's Dr. Reddy's Laboratories in the last quarter.
As drugmakers expand drug development and manufacturing around the world, logistics become important and often challenging. Suppliers, as well as drugmakers, have to figure out how to get ingredients and supplies to new destinations. Parexel is latching onto that opportunity with a new distribution center in Singapore, as well as expansion of operations in Billerica, MA.
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.
The private equity group announced this morning that it will buy out Medpace, continuing an M&A trend that has spurred a sizable shakeout of the CRO business in recent years. With outsourcing growing increasingly popular in the biopharma industry, the financiers are finding some significant upside in buying--and then selling--CROs.
With the the coming entry of biosimilars in the U.S. and expansion of that market in Europe, biologic drugs are going to be in greater demand, as will the contract manufacturers who can supply the cell lines and special services needed to get them to market. Okalahoma-based Cytovance Biologics is joining a number of CMOs that are adding capacities to tap that growth.
The FDA said Friday that Mentholatum is recalling a variety of over-the-counter eye drops after a review of manufacturing facilities raised questions of sterility. In another sign of the globalization issues facing the FDA, the drops being recalled were manufactured in Vietnam.