The US FDA has modified a 2013 consent decree issued to Ben Venue Laboratories, paving the way for new owners Xellia Pharmaceuticals to resume manufacturing at the dormant Ohio site.
An API facility Cambrex is setting up in Charles City, Iowa will be operational later than planned due to delayed equipment deliveries and installation challenges.
Full production at Catalent’s Beinheim softgel plant has begun five months after the discovery of out-of-place capsules led to French regulators suspending operations.
Lonza plans to expand mammalian cell culture-based drug and viral manufacturing capacity after growth in both businesses helped it to record first quarter sales.
Fette Compacting has unveiled its first capsule filling machine, which is capable of outputting 400,000 capsules per hour – a new record in the industry.
3D printing can make drug production simpler and cheaper according to a UK expert who says using it for commercial production is about “numbering up” not scaling up.
Regulations, recruitment and facility refits are holding continuous manufacturing back, but a Rutgers’ associate behind J&J’s recent success believes industry can overcome these hurdles.
GSK has confirmed its new UK plant will continue to supply the US with Ellipta inhalers after capacity at its facility in North Carolina comes online this year.
The WHO has removed two APIs supplied by Anuh Pharma from its list of prequalified ingredients and announced plans to inspect the firm’s facility in Boisar, India.
Industry will be encouraged to adopt continuous manufacturing methods following the regulatory success of Janssen’s Prezista, says Rutgers University associate director and Interphex speaker Doug Hausner.
API manufacturer PCI Synthesis has set up a polymer development group citing growing drug industry demand for advanced coating technologies and excipient technologies.
Single-use is the future but stainless steel bioreactors will always play a role in drug production says an expert, who thinks firms could do worse than consult a CMO before deciding in which technology to invest.
The US FDA has published draft revisions to a thirteen-year old CMC guidance it says will increase the flexibility of post-approval changes for drugmakers.
Several US states have approached Braeburn Pharmaceuticals after the firm said it was reassessing plans to invest $20m in North Carolina following the passing of House Bill 2.
Janssen is already working on continuous manufacturing methods for other drugs says Rutgers University which helped develop the new Prezista production process approved by the US FDA.
WellSpring Pharma Services has announced a $3 million capital investment in new equipment in addition to a new strategic partnership with IDT Australia to manufacture drugs targeting the US market.
Recipharm has completed the acquisition of a majority stake in India’s Nitin Lifesciences in a deal the Swedish contractor says strengthens its presence in an important market.
Pharmachem Technologies has started expanding its API facility in Grand Bahama just days after its main customer Gilead Sciences won US FDA approval for a new HIV drug.
Anti-LGBT legislation has prompted Braeburn Pharmaceuticals to reassess plans for a $20m facility in North Carolina, but will others in "the nation’s number one state for biomanufacturing" follow suit?
For the third year in a row, about 30% of Deloitte poll respondents say their companies experienced supply chain fraud, waste, or abuse in the previous year.
Aesica has doubled early formulation development capacity and added controlled drug handling capabilities at its manufacturing facility in Queenborough, UK.
Catalent has missed its forecast for bringing a suspended softgel facility back online, but says production of essential drugs has begun at the French plant.
Brammer Biopharmaceuticals and Florida Biologix have merged to create a cell and gene therapy biologics CDMO in preparation for a “tidal wave” of gene therapy products.
The European Pharmacopeia Commission has adopted a revised monograph that allows a broader range of purification methods to be used for the production of water for injectable pharmaceuticals.
The US FDA says it will not approve Opko's kidney disease drug Rayaldee until contract manufacturer Catalent fixes problems at its softgel plant in Florida.
