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Hot Topics > Globalisation

Globalisation

Globalisation

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.

GSK exiting Australian OTC site: over 200 jobs to be lost

07-Nov-2016 - GSK says it remains dedicated to Australian despite announcing plans to shutter a painkiller manufacturing site in Sydney.

Recipharm invests €1.2m in Italian small-scale API capabilities

02-Nov-2016 - Smaller drugmakers are shifting away from generics and towards niche new molecules says Recipharm, which has expanded a small-scale API facility to feed demand.

CFDA: reports of clinical trial data fraud 'not fact based'

25-Oct-2016 - The Chinese Food and Drug Administration (CDFA) has fired back on lack of context in media reporting “80% of China’s clinical trial data are fraudulent.”

Dispatches from CPhI Worldwide

UK-based CMOs benefitting from currency exchange post-Brexit vote

07-Oct-2016 - UK-based contract manufacturers are benefitting from the weak pound following the country’s referendum in June, but the long-term impact of Brexit is still unknown.

AbbVie API plant opens in Singapore as first part of larger $320m site

29-Sep-2016 - AbbVie has opened an oncology and women’s health API plant, part of its planned 120,000m2 small and large molecule manufacturing site in Singapore.

Attention Amgen: Canada OKs Samsung Bioepis and Merck's Enbrel biosimilar

12-Sep-2016 - Canada has approved Brenzys, its first biosimilar version of Amgen’s Enbrel (etanercept) made by Korean drugmaker Samsung Bioepis.

India turns to certification in pharma manufacturing quality drive

01-Sep-2016 - India's government has launched a certification programme aimed at tightening up quality standards in its domestic drug industry.

Hikma continues beefing up US and European manufacturing capabilities

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.

AstraZeneca: Retaining current regulatory procedures crucial, post-Brexit

01-Aug-2016 - AstraZeneca says it will be critical to avoid duplicated regulatory efforts and costs once the UK leaves the European Union.

GSK commits to UK manufacturing with £275m investments across three sites

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.

Brexit: Indian firms worried but Big Pharma and EMA remain positive for now

Worried and bewildered: Brexit sparks uncertainty for Indian pharma in Europe

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.

Biotrinity 2016

UK fully supportive of complex pharma manufacturing, George Freeman MP

28-Apr-2016 - Precision pharmaceutical manufacturing is crucial to the UK’s economy, according to life science minister George Freeman MP.

Biotrinity 2016

Biopharma 'future is better in Europe,' says UK life science minister

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.

Novo Nordisk €100m expansion to add 250 jobs in France

21-Apr-2016 - Novo Nordisk has announced plans to expand an insulin production site in France in the latest investment in its manufacturing network.

US FDA hits another Indian drugmaker over data integrity issues

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.

US FDA guidance looks to stem ‘major problem’ of data integrity

18-Apr-2016 - The US FDA has issued draft guidance to address the recent torrent of data integrity problems at drug manufacturing sites.

Opinion

Will North Carolina 'Bathroom Bill' drive pharma away?

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?...

US FDA questions facility design in Warning Letter for Emcure's Pune plant

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. 

Novartis consolidating NY dermatology sites but says no jobs at risk

10-Mar-2016 - Sandoz will consolidate two New York sites manufacturing semi-solid creams and ointments for its dermatology subsidiary, Fougera Pharmaceuticals.

Recipharm to invest €40m in serialization tech ahead of EU and US track and trace rules

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.

AstraZeneca: China formulated anaemia drug on fast-track, but timeframes vague

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.

Shasun takes ‘Strides’ in Africa and Aus through double acquisition

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.

Indonesia mulls foreign JVs and reduction on imports to boost local API production

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.

Ipca not surprised by US FDA warning at three Indian API plants

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.

Regulatory reforms to reshape drug manufacturing in China says expert

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.

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