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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.

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.

AstraZeneca opens $224m Russian plant for local production

22-Oct-2015 - AstraZeneca has opened a $224m manufacturing site in Russia it says is the largest foreign pharma investment in the country.

Pharmerging markets will be a $500bn 'game changer,' says Reva

21-Oct-2015 - ‘Pharmerging markets’ have extended beyond Brazil, Russia, India and China (BRIC) and will be worth $500bn by 2020, according to Reva Pharma.

Hovione to refurbish ex-generics plant for oral and inhalable formulation site

20-Oct-2015 - Hovione will spend $10m refurbishing a plant acquired from a Portuguese generics company to create an oral and inhalation formulation site.

Dispatches from CPhI

Around 80% of data integrity issues QC related, says CPhI expert

15-Oct-2015 - Increased efforts by the US FDA have made data integrity the hot topic on GMP compliance, according to a regulatory expert.

Dispatches from CPhI

EFCG: ‘API’ days for Europe as Big Pharma returns in search of quality

15-Oct-2015 - Big Pharma has returned to Europe for its API sourcing due to reasons of quality and reliability, according to the European Fine Chemicals Group (EFCG).

European API makers must invest to compete with India, says Infa Group

14-Oct-2015 - Clients are turning their backs on low-cost economies like India and returning to Infa Group, the Italian API maker says.

UPDATE

UK and India sign agreement to help ensure drug quality

05-Oct-2015 - The MHRA has signed a Memorandum of Understanding (MOU) with Indian regulators to help ensure the quality of drugs in the UK.

GSK will create 300 new production jobs in France despite R&D pull out

GSK in France: 'Oui' to manufacturing, 'non' to R&D

28-Sep-2015 - GSK is selling a French R&D site as part of a global restructuring move but says it will continue growing its manufacturing presence in the country.

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