There has been a raft of drug manufacturers adding sterile manufacturing capacity as that market grows, and another is getting in on that action.
Jubilant HollisterStier, a contract manufacturer, says it has completed the first phase of an expansion at a plant in Montreal. The company did not give specifics but said the project increases its capacity there by nearly 200% and will be ready for products early next month.
Earlier this week, India's Aurobindo Pharma said over the next 18 months to two years it will significantly boost capacity at a new facility near Hyderabad that is making sterile injectable drugs.The company has applications filed for 31 new drugs for the plant and expects growth in product sales to go from about $2.5 million a month now to between $8 million and $10 million over the next 6 to 8 quarters.
Mylan ($MYL), which expects to become a dominant player in sterile injectables if it completes its $1.6 billion buyout of the sterile operations of India's Strides Arcolab, told Indian authorities it has big expansion plans there. It said recently that it expected to become the largest producer of sterile injectables for the Indian market, with plans to boost capacity from 180 million units annually sold in India to 600 million units by 2017.
While Jubilant HollisterStier is celebrating the expansion of the Montreal plant, it also is dealing with FDA concerns over sterile manufacturing at the site. In March, the FDA posted a warning letter it sent to the company criticizing the contract manufacturer for releasing lots from the plant even though some of the batches were out of spec.
- here's the announcement