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UK Moves to Prevent API Shortages Ahead of New EU Import Laws

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.

Related news

Shasun Pharmaceuticals’ says it is trying to restart operations at the earliest opportunity after workers went on strike at its API and formulation facility in India last Sunday.

Teva has affirmed its respiratory drug delivery strategy with the purchase of MicroDose Therapeutx for a potential $165m (€123m).

Issues with GSK's Bottle Manufacturer Leads to MHRA Ventolin Alert

A GlaxoSmithKline subsidiary has issued a recall of two batches of Ventolin syrup in the UK after glass fragments were found in some bottles.

Survey: Quality System Issues Most Frequent Cause of Drug Shortages

Manufacturers’ quality issues were among the most prevalent reasons for drug shortages, according to a new industry survey.

Global Industry News

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.

CROs Forge Imaging Partnership to Meet Biopharma Industry Need from Outsourcing-Pharma.com

MPI Research, inviCRO and 3D Imaging are partnering to combine their imaging tools at a new center in Michigan aimed at large biopharma clients.

Insulin CMO Sued by US City Over Failed Manufacturing Plant

Insulin CMO Sued by US City Over Failed Manufacturing Plant from Outsourcing-Pharma.com

A US CMO that promised to make cost-effective, generic insulin has been sued by the city where it planned to set up a manufacturing plant. 

DHL Launches Cold Chain Air Distribution Service from Outsourcing-Pharma.com

Logistics company DHL has launched a new temperature controlled air freight service to service for biologics.

Bioclinica Predicts Demand for TQT Trials in China

Bioclinica Predicts Demand for TQT Trials in China from Outsourcing-Pharma.com

Bioclinica has partnered with a Chinese hospital citing growing regulatory pressure for cardiac safety studies in the country as the key driver.

Spotlight

Confusion Abounds in Elemental Impurities Testing for Pharma, Excipients
Dispatches from Excipient Fest in Baltimore - UPDATE

Confusion Abounds in Elemental Impurities Testing for Pharma, Excipients

As the USP, ICH and US FDA all aim to tackle elemental impurities testing for pharmaceuticals and...

China Looks to Tighten Excipient Regulations with Limited Resources
Dispatches from Excipient Fest in Baltimore

China Looks to Tighten Excipient Regulations with Limited Resources

China’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 Pfenex

Injex Gets China Approval; Glide to Make Solid-Dose Anthrax for Pfenex

Injex 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 2020

GMP Plants and BioPharma Clusters Drive Russia's Pharma 2020

International GMP standard facilities and six biopharma centres will lead Russia’s initiative in implementing its Pharma 2020...