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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.

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18-Apr-2016 - The US FDA has issued draft guidance to address the recent torrent of data integrity problems at drug manufacturing sites.


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.

Novartis: Centralised manufacturing unit will harness tech, not reduce network

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.

Increased US FDA oversight driving recent China plant warnings

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.

Pharma in emerging economies: risks, concerns, and considerations

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.

Colorcon sweetens its offering with Paulaur's pharma sugar sphere biz

19-Jan-2016 - Colorcon has acquired Paulaur Corporation’s sugar sphere business to help feed pharma’s demand for multiparticulate dosage forms.

US FDA and French regs hit separate Chinese API makers with warnings

14-Jan-2016 - Systemic data manipulation has landed Chinese API maker Zhejiang Hisun Pharmaceutical with a US FDA warning letter.

Out with the old, in with the new… CEOs. Pharma's top-level rejigs

11-Jan-2016 - Valeant, Rentschler, Celgene, MannKind, and Syngene are among those welcoming new leaders for 2016. Oh, and Turing waves goodbye to Martin Shkreli… welcome to a New Year’s CEO special.

Kalbe Farma to build Indonesian facility to tackle import challenges

06-Jan-2016 - Kalbe Farma has launched construction plans for a local raw materials facility in a bid to tackle import challenges.

Tech capabilities to offer CMOs advantages in stable oral dosage sector, report

01-Dec-2015 - Niche technologies will differentiate CMOs looking for a slice of the steady oral dosage manufacturing industry, according to an industry report from ISR.

Pharma unhappy with French 'made in EU' proposal

19-Nov-2015 - France's government has proposed new labelling for medicines that would indicate whether the contents were manufactured in or outside Europe.

Antibiotics: urgent calls for global payment pot

17-Nov-2015 - As World Antibiotics Awareness Week draws attention to the threat of resistance, pharma companies large and small say a worldwide overhaul of payment models will make anti-infective R&D profitable again....

Government blames India's poor quality stigma on 'turf war' with West

09-Nov-2015 - The over-reaction to quality infringements by Indian drugmakers is part of a “turf war” with Western firms, the Indian Government says.

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