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Hot Topics > 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.

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.


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.

EC, EU and WHO share 'need to know' private drug data

23-Sep-2015 - European regulators and the WHO have begun sharing confidential information about drug applications, quality, and inspections under a new agreement.

Novo Nordisk building its first manufacturing facility in Middle-East

Novo Nordisk injecting €70m in Iran for insulin pen production plant

22-Sep-2015 - Novo Nordisk will build a manufacturing plant for its FlexPen prefilled insulin device in Iran to cater for the local market. 

Integration and consolidation: Pfizer spending $1bn+ as it considers 2016 split

21-Sep-2015 - Pfizer is realigning its manufacturing capabilities as part of a billion dollar plan that could see the company split next year.

Biocon launches insulin pen, fully 'made in India' from new device plant

16-Sep-2015 - Biocon has begun commercial manufacturing at its Bangalore devices facility to support the launch of its insulin pen product, Basalog One.

Putin: Industry must back Russia's 90% domestic drugmaking target

09-Sep-2015 - Vladimir Putin says support from Russian business community is needed to help achieve the domestic drug manufacturing goals set out in his Pharma 2020 policy.

Sandoz closing Mumbai API plant but says it remains committed to India

15-Jul-2015 - Sandoz will shutter an Indian API facility in 2016 as part of a manufacturing refocus in the region.

Israel, Brazil added to list of countries with API GMP standards equivalent to EU

07-Jul-2015 - The European Commission last week officially added Israel and Brazil to a list of countries outside the EU that have standards of manufacture and supervision of APIs equivalent to those...

Allergan targets Actavis legacy plant in Iceland in cost-cutting move

02-Jul-2015 - Manufacturing operations at an Actavis legacy site in Iceland will cease and products will be transferred out the country from 2016, Allergan has announced.

BIO 2015

TTIP trade talks will 'force' FDA-EMA to sync regs, says biopharma

23-Jun-2015 - Eli Lilly’s President of Biomedicines says the transatlantic trade agreement TTIP will “force” the FDA and EMA to standardise regulations on manufacturing and trials.

Exporting to Brazil? ANVISA is tough and hands-on, says Kemwell

10-Jun-2015 - Site audits by Brazilian pharma regulator ANVISA are “exactly the opposite” to the US FDA’s, says CMO Kemwell as it prepares to export to Brazil for Johnson & Johnson.

Pharma: Ensuring supply is priority as Greek drug debt passes €1.1bn

10-Jun-2015 - Drug companies will continue to supply Greece for the time being, but mounting debts make it hard to predict what will happen in the longer term according to industry group...

US preference for ANSI 363 excipient standards will change, says EXCiPACT

03-Jun-2015 - Multinational excipient-makers will drive US interest in EXCiPACT, the industry-led certification scheme says as a UK Colorcon plant becomes the eighteenth site to receive accreditation.

FDA needs to conduct all generic manufacturing inspections requested by reviewers, report says

07-May-2015 - Although the US FDA has drastically increased its preapproval inspections of generic drug makers worldwide, the agency failed to conduct all of the inspections requested by its own generic application...

Mylan rejects $40bn bid, questions Teva’s credibility

28-Apr-2015 - Mylan has rejected an unsolicited bid by Teva and upped its offer for Perrigo, as the ongoing saga in the generics space continues.

Special from BPI Europe 2015

Eliminating fear culture can save operational costs and jobs, says Pfizer

23-Apr-2015 - Pfizer reduced costs 40% without cutting jobs at a facility in Sweden using an alternative approach to organisational and cultural behaviour, and hopes to do the same at its newly acquired Austrian...

Tech transfer will drive pharma investment in Africa, says industry group

23-Apr-2015 - Technology transfer is the first step to bringing pharma investments to Africa, says the African Regulatory Network (ARN).

Allergan axing a further 577 at Cali HQ, post-Actavis acquisition

21-Apr-2015 - Almost 600 staff at Allergan’s headquarters in Irvine, California, will be laid off in the Botox maker’s latest round of job cuts.

Collaboration is key to combatting counterfeiting

Fighting fake drugs about patient safety not competitive advantage says Rx-360

09-Apr-2015 - Fighting drug fakers relies on collaboration according to supply chain security group RX-360, which says drugmakers put rivalries on hold in the war against counterfeiters.


Pfizer, Amgen’s Form 483s listed among more than 100 issued by US FDA already in 2015

08-Apr-2015 - Three Amgen manufacturing sites, along with Pfizer’s Perth, Australia site are part of a list of more than 100 US FDA Form 483s issued so far in 2015, according to...

'Unjustified' ban of GVK-tested drugs has damaged India, says Pharmexcil

08-Apr-2015 - The reputation of Indian clinical trials has been damaged by the “unjustified” suspension of medicines tested by GVK Biosciences, Pharmexcil says as it attacks the evidence submitted by French regulators.

Calling all QA/QC whizzes: US FDA 'super' office hunts quality leader

07-Apr-2015 - The Director of the new 'super' Office of Pharmaceutical Quality must address issues surrounding increasing globalisation and manufacturing complexity, the FDA says as it begins the recruitment process.

Sanofi: 80% of population ignored as pharma targets lower-risk specialty R&D

02-Apr-2015 - Pharma has focused investment in lower risk specialty and orphan diseases to the detriment of 80% of the population, according to Sanofi’s head of R&D who calls for regulatory convergence...

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