Anti-infectives firm Xellia has moved its North American HQ to the lyophilisation plant in Raleigh, North Carolina that it bought from Fresenius Kabi last July.
The Italian Ministry of Health has banned compounding pharmacies from preparing drugs containing any of seven APIs after chemists were discovered making dangerous off-label weight loss treatments.
There’s little chance US companies will consider Iran as a venue for pharmaceutical contract manufacturing, even in the current era of limited détente between the two countries, experts say.
Contract manufacturer Emergent BioSolutions and biosimilar developer Pfenex have both announced in recent days that they’ve won contract manufacturing and development grants with the US government.
The huge former Ben Venue injectables manufacturing plant in Ohio that became the center of controversy over drug shortages a few years ago remains off line, and the company that now owns the site reiterated this week that it has no plans to resume making...
Manufacturers of excipients are being sent inappropriate requests for stability data by some regulators and pharma companies, threatening to disrupt the supply chain, IPEC claims.
The Bill & Melinda Gates Foundation’s PATH Malaria Vaccine Initiative (MVI) has selected CMC Biologics for process development and manufacture of specific monoclonal antibodies (mAbs) to test for their capacity to protect humans from malaria infection.
Contract manufacturing will rise over the next five years as drugmakers feel the pressure to reduce supply chain time, and choose to focus on in-house R&D rather than conduct their own manufacturing.
Service provider and contract manufacturer WuXi PharmaTech is vouching for TruTag Technologies’ edible microtags following a pilot project adding to evidence that they can help root out counterfeits.
A host of recent small deals, expansions, office openings and other news from CDMOs (contract development and manufacturing organizations) and CROs (contract research organizations) around the world.
New Jersey-based generics CMO (contract manufacturing organization) Amneal Pharmaceuticals has purchased a 200,000 square foot facility in Cashel, Ireland.
The US FDA has accepted for review Opko Health’s New Drug Application for a potential treatment for chronic kidney disease (CKD) and vitamin D insufficiency that uses Catalent’s proprietary softgel technology as its delivery platform.
With contract revenue growth of nearly 40%, CDMO (contract development and manufacturing organization) AMRI is seeing its acquisitions of OsoBio, two Aptuit facilities and a UK aseptic facility pay off.
French biotech TxCell is outsourcing manufacture of its T-cell therapy Ovasave to MaSTherCell, and says it expects to regain GMP certification of its own site later this year.
Baxter’s contract manufacturing business is expected to take a nearly 10% hit as one of its "major customers" has elected to self-manufacture products previously made by the CMO (contract manufacturing organization), Baxter CFO James Saccaro...
CDMO (contract development and manufacturing organization) Xcelience has made a structured cash investment in Pennsylvania-based Powdersize, which specializes in milling, micronization and powder size classification.
"People are the essence of the company going forward," said Teva, referring to the news that the world's largest generic drug maker will purchase Allergan's generics business for $40.5bn, at its Q2 financial results press conference...
Pharma firms may need to carry-out an analytical method comparability study as part of the life cycle management of a drug, according to final US FDA guidelines.
A Standards & Poor analyst has rated contract development and manufacturer AMRI as ‘stable,’ but says it lacks the scale and breadth of offerings of its competitors in the CDMO industry.
Roche is expanding its manufacturing operations to service its biologics pipeline, but the firm says it will continue to outsource approximately 20% of all production.
Capsugel is doubling the size of a facility in Scotland to support demand for the encapsulating of drugs containing high-potency active pharmaceutical ingredients (HPAPIs).
Lonza has reported higher revenues and profits for H1 2015, but warned that the strength of the Swiss franc means its Visp facility is still finding it hard to compete.
Inspectors found significant violations of cGMP at sterile drug compounders - both registered as outsourcing facilities - in Florida and Arkansas during visits in March.
Demand for West’s wearable injector - which uses the recently-approved Crystal Zenith delivery system - has led to the expansion of a facility in Arizona.
AMRI has bought Spanish contractor Gadea Pharmaceutical Group for $174m (€160m) to add muscle to its steroid API business and sign up more customers outside the US.
API firms that invest in waste management find it hard to compete with those that pollute according to DSM Sinochem, which wants environmental criteria included in GMP standards for environmental and business reasons.
Eisai has agreed to transfer ownership of its Research Triangle Park (RTP) manufacturing campus to Biogen, which will continue to manufacture oral solid-dose products and parenteral products at the sites for Eisai.
Avid Bioservices' expansion will double existing capacity to service both a $40m backlog and its owner Peregrine, which is hoping to commercialise its breast cancer candidate.
Drugmakers risk losing financial backing if they source APIs from Indian suppliers that pollute according to Nordea Asset Management's head of responsible investments, Sasja Beslik.
Proteon Therapeutics has extended a deal with Lonza for the development and manufacture of its lead product, the pancreatic elastase candidate vonapanitase.
With no active production at the plant since 2013, the company said it would shutter its Mumbai, India-based facility in mid-September, according to a Bombay Stock Exchange filing.
