Discover innovative single-use mixer for efficient mixing of low shear and particulate sensitive solutions in cGMP environment
ATMI Life Science
EU Risks Drug Shortages If API Import Regs Not Waived for US Says SOCMA
 |
Europe could face drug shortages if the US is not granted exemption from new API import requirements, according to a US chemical industry trade association. Related news |
News in brief
Sanofi has ended production at a historic London facility and says it plans to turn the site into a dedicated science park.
Phyton Biotech has received European approval for a version the cancer drug API docetaxel whose production does not rely on the scarce yew tree extract used in traditional manufacturing methods.
A GlaxoSmithKline subsidiary has issued a recall of two batches of Ventolin syrup in the UK after glass fragments were found in some bottles.
The UK MHRA plans to let drugmakers import APIs that lack ‘written confirmation’ of quality if there is an overriding need to ensure continued supply.
Global Industry News
AMRI's Burlington Plant Given Controlled Substance Boost from DEA from Outsourcing-Pharma.com
The DEA has approved AMRI’s Burlington facility to work with Schedule 2 controlled substances, placing it in a competitive position to win contract manufacturing bids, the company says.
Pfizer Selects South African Trial Sites for Partnership Program from Outsourcing-Pharma.com
Pfizer has chosen three of Synexus' clinical research centres in South Africa to be a part of its 100-site INSPIRE programme based on the sites’ experience and audit history.
Wuxi to Help Develop, Manufacture ADC Candidate in China from Outsourcing-Pharma.com
Ambrx and Zhejiang Medicine have selected Wuxi to accelerate the development of a potential ADC (antibody drug conjugate) targeting Her2-positive breast cancer.
Parexel Backlog May Indicate Future Revenue Boom from Outsourcing-Pharma.com
CRO Parexel’s massive backlog could position the company for continued revenue growth moving forward, top executives said at recent conferences.
Spotlight
  Dispatches from Excipient Fest in Baltimore - UPDATEConfusion Abounds in Elemental Impurities Testing for Pharma, ExcipientsAs the USP, ICH and US FDA all aim to tackle elemental impurities testing for pharmaceuticals and... |
 Dispatches from Excipient Fest in BaltimoreChina Looks to Tighten Excipient Regulations with Limited ResourcesChina’s implementation of GMPs for excipient manufacturers, as well as a developing US FDA-style DMF system, have... |
 Injex Gets China Approval; Glide to Make Solid-Dose Anthrax for PfenexInjex says it is looking for partners to prefill its device and Glide will develop Pfenex’s anthrax... |
 GMP Plants and BioPharma Clusters Drive Russia's Pharma 2020International GMP standard facilities and six biopharma centres will lead Russia’s initiative in implementing its Pharma 2020... |
Most Popular News
Key Industry Events
BioPharm America™ 2013—6th Annual International Partnering Conference
Boston, MA, USA / Conference