The US FDA is beginning to push CMOs and other manufacturers away from using real-time release testing as a shortcut to ensuring drug quality and reducing end product testing, experts said.
With backing from the Australian Government, DSM has opened a mammalian cell culture operation to fuel the growing demand in the Asia-Pacific biologics market.
The cash-strapped FDA is looking to cut corners any way it can, especially if it can hone in on which pharma manufacturing facilities and sites need to be prioritized for inspections.
The FDA has finalised guidance on the manufacturing of antibiotics in order to prevent cross-contamination of finished pharmaceuticals and APIs with non-penicillin beta-lactam drugs.
Despite offers from Amgen and Novartis reportedly worth up to $2bn, Hikma announced last week it will keep its profitable and growing injectable business.
ATMI has started selling a new cGMP-compliant fill finish platform in a continuation of its focus on what it says is the growing single-use tech market.
US regulators have rejected Allergan's candidate migraine drug Levadex for a second time, this time citing concerns about the CMO - Exemplar Pharma - the Californian drugmaker acquired earlier in the week for $20m.
GlaxoSmithKline’s contract manufacturer has experienced unspecified manufacturing issues that are expected to set back supplies of its restless leg treatment Horizant until June.
Merck & Co. has opened a new packaging facility in China to support its emerging market strategy but says it is still committed to traditional regions.
One day after Purdue Pharma’s blockbuster opioid OxyContin lost its first patent, the US FDA has amended the drug’s label and now requires generic drugmakers to adopt similar abuse-deterrent formulations.
The expansion of CoreRx’s Clearwater, Florida facility will allow for hormone development, clinical trial and commercial manufacturing, and create about 25 new jobs.
Thermo Fisher Scientific has agreed to purchase genetic testing equipment maker Life Technologies for $13.6B in one of the biggest acquisitions of the year.
Bristol Myers-Squibb says its $250m (€191m) expansion of its US biologics facility will centralize its processes and become a springboard to launch new products.
The US FDA has opened for public comment a new ICH draft guideline that aims to help manufacturers identify and control mutagenic impurities during the development of new drugs.
GE Healthcare and iBio are in talks about future projects after confirming they are working on a plant-based vaccine manufacturing site for Brazilian drugmaker Fiocruz/Bio-Manguinhosin.
Alkermes says it intends to continue investing in its Irish facility although a restructuring plan will end some manufacturing operations and cost 130 jobs.
The manufacturing sites of Alexion Pharmaceuticals and Italy-based Wyeth Lederle S.p.A were cited in FDA warning letters for cGMP (current good manufacturing practice) violations in their production of APIs and finished pharmaceuticals, respectively.
The US FDA has cleared Janssen to release one Lot of Doxil made using an unapproved manufacturing process at Ben Venue's plant to help alleviate shortages.
India’s Directorate General of Foreign Trade (DGFT) has pushed back the deadline again for adopting new barcodes to track pharmaceutical exports by one year.
Bristol-Myers Squibb says shuttering Amylin’s San Diego facilities will accelerate its diabetes R&D joint venture with AstraZeneca though approximately 300 jobs will be lost.
China and India have more work to do to confirm their API manufacturing sites comply with EU GMP requirements, according to the European Commission’s Pharmaceutical Committee.
Lilly says another investment in its Indianapolis facility will add a second insulin cartridge-filling line and is driven by the increasing prevalence of diabetes.
BD says a brand new facility and sustainable pricing will allow the company to compete as it enters the generics market following FDA approval of its first injectable drug.
Sanofi has inked a deal that will see it contract manufacture immunotherapy products for Transgene using a new platform developed by the two companies.
Pfizer’s Rifampin injections used to treat TB (tuberculosis) are in short supply as the company says manufacturing issues caused some vials and solutions of the drug to be possibly contaminated.
Evonik gets the thumbs up from the MHRA, Recipharm's approved by Japan and Simcere passes the Chinese regulatory test – welcome to Outsourcing-Pharma’s round-up of GMP accreditation.
French CMO Indicia production says the acquisition of Biotechnologie Appliquee will strengthen its ready-to-use media manufacturing and add R&D capabilities to its offerings.
The US FDA has waived normal pre-approval inspection requirements and cleared CMO Cook Pharmica to make an injectable drug that is currently in short supply.
As the dissolution of Angel continues, its core manufacturing facility has been bought by AB Technology ensuring long term operations and rescuing 23 jobs.
The US Environmental Protection Agency (EPA) says Teva still needs to address environmental issues at Missouri API plant landed with a $2.3m civil penalty.
Following last week’s shuttering of a manufacturing plant administrators have sold Angel Biomedical to new company Collbio as they start offloading CMOs assets.
Progenitor Cell Therapy (PCT) has started testing to see if an RNA-based characterization tech developed by Sistemic can improve cell therapy production.
