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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.

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.

Update

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...

Hamburg exits US FDA calling on increased international co-operation

01-Apr-2015 - Margaret Hamburg has called for increased regulatory co-operation to tackle the issues raised by globalisation of the drug industry as she steps down as Commissioner of the US FDA.

No more waiting for the Sun: FTC approves $4bn Ranbaxy acquisition

30-Mar-2015 - Sun Pharmaceutical Industries has completed its $4bn (€3.7bn) acquisition of Ranbaxy after receiving the thumbs up from the US Federal Trade Commission (FTC).

Aarti says US FDA has not detailed GMP problems that earned it an import ban

27-Mar-2015 - Aarti Drugs says the US FDA has not provided details of observations that earned its E-22 facility in Tarapur, India an import ban.

Dispatches from DCAT

Message is clear: Europe is in trouble in terms of pharma growth, experts say

17-Mar-2015 - The European pharma market isn’t likely to deliver much growth over the next five years as generic markets commoditize, IMS Health VP Graham Lewis warned participants at the DCAT (Drug,...

EMA calls for industry involvement in applying new ISO standards to drugs

23-Feb-2015 - The EMA wants help applying new ID and information standards to medicines sold in Europe and has asked drugmakers to join its implementation taskforce.

Rebooting HAL part of Indian plans to boost API capacity and cut reliance on China

19-Feb-2015 - The Indian Government wants to build API production capacity and revive state run manufacturer Hindustan Antibiotics to cut reliance on Chinese imports.

PE-backed Laurus Labs sets up US drug ingredients business

16-Feb-2015 - Warburg Pincus-backed HIV drug ingredient firm Laurus Labs has set up a US presence and development facility in a bid to win more North American customers.

Pfizer 'comfortable' with Hospira's manufacturing network after quality review

09-Feb-2015 - Pfizer visited three troubled facilities in Hospira’s manufacturing network before entering a $17bn definitive merger agreement, the company says.

UPDATE

Novartis: New cost-saving unit will not target manufacturing network

29-Jan-2015 - Novartis has divested, restructured, or mothballed 24 manufacturing plants since 2010 but says its new NBS cost-saving business will not focus on streamlining and consolidating sites.

Catalent to offer integrated services in Germany through softgel expansion

27-Jan-2015 - A coating and packaging expansion at a facility in Germany will feed the demand for end-to-end softgel services, Catalent Pharma Solutions says.

Ocean rises for drug transportation due to cost and cold chain concerns

15-Jan-2015 - AstraZeneca and Baxter are opting to transport pharmaceuticals by ocean and land routes as costs and cold chain security drive a drop in air freight.

China-based paracetamol maker hit with US FDA warning letter

06-Jan-2015 - Novacyl Wuxi Pharmaceutical has received a US FDA warning letter for failing to investigate the origin of metal particles found in drugs made at its paracetamol plant in China.

Swedish manufacturing: special report

‘Embarrassment’ holding back green manufacturing, says Sweden

22-Dec-2014 - Sweden’s pharmaceutical regulator is pushing hard to make water pollution regulations a binding part of GMP, and says “embarrassed” European agencies are dragging their feet more than big pharma.

After AZ R&D exit, CMOs anxious to keep pharma in the country

11-Dec-2014 - Pharma companies have called on the Swedish government to prevent manufacturing going the way of R&D and leaving the country, after AstraZeneca closed its research in Lund in 2012.

From CPHI India

Eager-to-please Indian manufacturers creating GMP chaos says expert

08-Dec-2014 - Cultural differences and broken promises are behind Indian GMP failures and acute generics shortages in the UK, according to one pharmaceutical distributor.

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