Growth of Pharma strategic partnerships with contract development and manufacturing organisations (CDMOs) is driving consolidation, according to an industry report.
Janssen Pharmaceuticals is prepared for Tramadol's reclassification by the US Drug Enforcement Administration (DEA) and says the supply of its versions of the opioid analgesic will not be interrupted.
A quality assurance audit is as beneficial to the CMO as it is to the sponsor selecting a third-party manufacturer, according to an ex-Merck Serono and MHRA consultant.
Several international CMOs will establish themselves in Russia over the next few years as pharma looks to satisfy the country's manufacturing policies, the CEO of R-Pharm predicts.
With almost a week before Indian exporters would be required to put bar codes on their primary packages, the Directorate General of Foreign Trade (DGFT) in India has pushed back the deadline indefinitely.
Pharmaceutical companies are rushing to respond to shortened deadlines from China’s Food and Drug Administration (CFDA) for serialising drug packaging.
Formulations that stop biopharmaceuticals being degraded by vials and syringes could help biopharmas avoid recalls and improve product shelf life says the UK team behind an industry focused research collaboration.
Clondalkin Pharma & Healthcare has been fined £12,000 for safety failings after a worker was injured by unguarded machinery at the contract packaging and printing firm’s facility in Cambridgeshire, UK.
CMO (contract manufacturing organization) AMRI has agreed to acquire Oso Biopharmaceuticals Manufacturing for $110m in cash and thereby expand to late-stage and commercial product manufacturing.
Sponsors trialling drugs in Asia should insist on the highest manufacturing standards and consider local production to successfully navigate the varied and complex regulations that govern research in the region says Almac.
As part of a wave of good news for the beleaguered Hospira, the company said it will inject $120m into its McPherson, Kansas, facility, which will result in 150 new jobs over the next five years.
California-based Relypsa has entered into a seven-year commercial manufacturing and supply agreement with DSM Fine Chemicals for the API for patiromer, the company's novel polymer in development for the treatment of hyperkalemia. Financial details...
Boehringer Ingelheim says the Saudi Arabian market is a huge drive for big pharma as it teams with local firms to manufacture secondary packaging for 26 products.
Biopharma is ramping up the outsourcing of some of the easier tests while tasks such as downstream process development and QbD services are being outsourced less, according to a new survey.
As pharma manufacturers look to cut costs and increase quality, over 70% of industry executives interviewed for a recent CPhI report say they are actively investing in manufacturing techniques and technologies to achieve these goals.
Patheon and DSM’s Pharma Products merger is “highly complementary” with crossover limited to North American oral solid manufacturing growth, says DPx as it targets further growth opportunities.
Shire has recalled one batch of its Gaucher’s disease drug VPRIV in the US after problems at its fill finish contractor resulted in particulate matter ending up in the vials.
FDA guidance on product design has driven demand by pharma for tailored designs for tablet colour, size and shape, specialist consultancy Colorcon told Outsourcing-Pharma.com.
As part of an effort to ease the transition between clinical and commercial launch for blister products, Almac has added new blistering technology at its US commercial packaging facility in Audubon, PA.
Pfizer says its hypothyroid drug Levoxyl will be available within a week after a musty smell coming from the oxygen-absorbing canister stopped production last February.
Eli Lilly is spending €75m ($102m) to meet latest global anti-counterfeiting regulations, its security experts said in an exclusive interview with in-Pharmatechnologist.com.
The combination cholesterol drug Liptruzet will be unavailable in the US for the foreseeable future, says Merck & Co., after packaging defect at CMO led to a total product recall.
Roche has asked Tamiflu distributors to prioritize US regions hardest hit by flu as it works to address packaging delays expected to limit supplies of the oral suspension version of the antiviral for the rest of the month.
Patheon is the world’s largest pharmaceutical development services (PDS) provider and third largest contract manufacturer, according to a report released yesterday.
Firms selling drugs in Brazil have three years to implement track and trace systems capable of monitoring drugs from the factory floor to the pharmacy under a new plan approved by Anvisa.
Pharmacy chain Boots UK has expanded a recall of some own-brand drugs after detecting a fault in a manufacturing line that applies tamper evident seals.
Soon to merge CMO Patheon has increased solid dosage form production capacity at its site in the UK and posted an improved set of preliminary results for the financial year.
Unilife has signed a $40m long-term supply agreement with Hikma and says it is committed to becoming the world’s largest and most successful injectable drug delivery systems supplier.
Vetter says plans for a $100m (€74m) expansion are driven by continued growth in the biopharma industry and keep the firm one step “ahead of the curve.”
Beleaguered sterile injectables manufacturer Ben Venue Laboratories has announced it will close permanently by the end of 2013 and lay off 1,100 employees in Ohio.
