When national businesses become global operations… With the industry sourcing more raw materials and services from around the world and distributing its products in new markets, companies are adapting their business processes to suit a more complex global operating environment.
12-Sep-2016 - Canada has approved Brenzys, its first biosimilar version of Amgen’s Enbrel (etanercept) made by Korean drugmaker Samsung Bioepis.
01-Sep-2016 - India's government has launched a certification programme aimed at tightening up quality standards in its domestic drug industry.
29-Aug-2016 - Hikma invested over $25m in its US facilities in the first half 2016, and plans to use excess capacity at a former Boehringer Ingelheim plant for contract manufacturing.
01-Aug-2016 - AstraZeneca says it will be critical to avoid duplicated regulatory efforts and costs once the UK leaves the European Union.
27-Jul-2016 - GSK will pump £275m ($360m) into its UK manufacturing network and says the country has a “leading position in life sciences” despite the recent Brexit vote.
28-Jun-2016 - Indian companies in the UK are among many in the pharma industry facing an uncertain future after Britain voted to exit the single-market last week.
28-Apr-2016 - Precision pharmaceutical manufacturing is crucial to the UK’s economy, according to life science minister George Freeman MP.
27-Apr-2016 - Britain’s minister for life sciences has called on the country’s £60bn pharma sector to rally together in support of remaining in the European Union.
21-Apr-2016 - Novo Nordisk has announced plans to expand an insulin production site in France in the latest investment in its manufacturing network.
21-Apr-2016 - Sri Krishna Pharmaceuticals has been hit with a warning letter after the US FDA found problems with quality data at a site in Hyderabad, India.
18-Apr-2016 - The US FDA has issued draft guidance to address the recent torrent of data integrity problems at drug manufacturing sites.
07-Apr-2016 - Anti-LGBT legislation has prompted Braeburn Pharmaceuticals to reassess plans for a $20m facility in North Carolina, but will others in "the nation’s number one state for biomanufacturing" follow suit?...
16-Mar-2016 - The US FDA has detailed GMP violations that prompted it to ban the importation of drugs made at an Emcure Pharmaceuticals plant in India last year.
10-Mar-2016 - Sandoz will consolidate two New York sites manufacturing semi-solid creams and ointments for its dermatology subsidiary, Fougera Pharmaceuticals.
10-Feb-2016 - Recipharm will invest €40 in serialization equipment to ensure it can comply with evolving track and trace regulations in the US, Europe and other markets.
09-Feb-2016 - AstraZeneca has reformulated roxadustat using materials sourced in China to make it eligible for fast track review through the country's new "green pass" process.
08-Feb-2016 - Indian drugmaker Strides Shasun has bolstered its generics manufacturing network by acquiring stakes in Kenya’s Universal Corporation and Australia’s Generic Partners Holdings.
02-Feb-2016 - Incoming Indonesian government measures to attract foreign manufacturing joint ventures (JVs) could include a regulation to reduce API imports, Vincent Harijanto, committee head GP Farmasia said.
01-Feb-2016 - Ipca has received an FDA Warning Letter at three Indian API facilities, but says it awaits re-inspection after already rectifying issues highlighted in a 2014 Form 483.
28-Jan-2016 - More plants in China will close says a US-based analyst who predicts that some drugmakers' inability to comply with stricter quality rules will create an opportunity for those that can.
28-Jan-2016 - Plans to centralise its manufacturing operations will optimise use of new technologies across Novartis’s divisions without resulting in any additional facility closures, the firm says.
27-Jan-2016 - The recent tide of Warning Letters issued to Chinese API and finished formulation makers reflects an increase in regulatory oversight, the US FDA says.
20-Jan-2016 - Emerging markets in BRIC nations are gaining traction and will be a key revenue driver for multinational pharma companies – but not without risk.
19-Jan-2016 - Colorcon has acquired Paulaur Corporation’s sugar sphere business to help feed pharma’s demand for multiparticulate dosage forms.
14-Jan-2016 - Systemic data manipulation has landed Chinese API maker Zhejiang Hisun Pharmaceutical with a US FDA warning letter.