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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.

Biological E’s new vaccine campus inaugurated

03-Feb-2009 -  Dr Rajashekar Reddy, chief minister of Andhra Pradesh, India presided over the inauguration ceremony for Biological E’s new INR3bn ($61m) vaccine and biopharmaceuticals manufacturing campus. 

WHO mulls comments from counterfeiting talks

02-Feb-2009 -  The WHO’s review of comments during a discussion of plans to redefine “counterfeit” will focus on “public health impacts of substandard, spurious, and falsely labelled products,” according to the organisation. 

CEE could gain from Asia’s reputation for fakes

22-Jan-2009 -  A new report suggests the large numbers of fake drugs produced in China could drive CMO customers away and see Central and Eastern Europe (CEE) emerge as a contract manufacturing hotbed.

FDA outlines ‘best practice’ for importers

21-Jan-2009 -  The US Food and Drug Administration (FDA) has issued a draft guidance on the measures pharmaceutical and other manufacturers should take to make sure imported FDA-regulated products are in line with federal statutes and regulations. 

News in brief

Drug CEOs hope to kickstart economy at April summit

19-Jan-2009 - CEOs from Pfizer, GSK and Abbott Laboratories are among those who will meet in to discuss the new business practices that must be put in place to adapt to the challenging economic climate.

FDA launches global supply chain pilot scheme

15-Jan-2009 -   In the latest part of its “beyond our borders” scheme, the US FDA is asking drugmakers to volunteer supply chain information for drugs and APIs sourced outside the USA.

Asian pack machine demand a boon US and EU industry

15-Jan-2009 -  The market for packaging machinery is set to grow 5 per cent a year and be worth $40bn (€30.3bn) by 2012, driven partly by a hike in demand for drug products in “pharmerging” economies, according to a new industry report.

Teamwork future of GMP inspections, says EMEA

14-Jan-2009 -  Despite criticism in certain quarters, joint GMP inspections represent the best use of resources in an increasingly globalised market, according to the EMEA.

News in brief

HHS/FDA set to open Indian offices

14-Jan-2009 -  Two new HHS/FDA food and drug safety offices in Dehli and Mumbai, India are the latest outpost of the US regulators “beyond our borders” campaign that has already seen it set up shop in China and Costa Rica.

Interview with IPEC China chairman Nevin Cheng

12-Jan-2009 - Since its inauguration last year, IPEC China has been working to improve the quality of excipient manufacturing in the country. in-PharmaTechnologist spoke with organisation president Nevin Cheng about the steps the body has taken so far and what it will be doing in 2009, including its plans for a new SFDA approved Drug Master File (DMF) scheme.

News in brief

Cuban prostate cancer vac sees clinical progress.

12-Jan-2009 -  Heberprovac, a prostate cancer vaccine being developed at the Camaguey Genetic Engineering and Biotechnology Centre has completed the initial phases of a clinical trial, according to the Cuban News Agency. 

GSK’s high-tech vaccines packaging plant plan

12-Jan-2009 -  An open house at GSK’s plant in Pennsylvania, US gave the world its first glimpse of the facility that the firm hopes will become the global hub of its vaccine packaging and filling business. 

Europe’s last paracetamol plant closes its doors

06-Jan-2009 -  As 2008 drew to a close and people the world over welcomed the New Year, few would have noticed the passing of Europe’s paracetamol industry as Rhodia closed the doors of the region’s last manufacturing facility in Roussillon, southern France. 

MonoSol targets MENA through Hikma deal

18-Dec-2008 -  MonoSol Rx and Hikma are teaming up to sell thin film pharmaceutical products in the emerging Middle East and North African (MENA) drug markets. 

CTx selects IDBS for drug development kit

16-Dec-2008 -  Australian drug development firm Cancer Therapeutics (CTx) has selected IDBS’ E-workbook and ActivityBase platforms to manage its global drug development programmes. 

News in brief

Eisai’s UK investment to create 300 UK jobs

04-Dec-2008 -  Eisai says that its £60m expansion of its R&D facility in Hatfield in the UK will create 300 new jobs, swelling its workforce to 500. 

Actavis selects Malta as Africa waypoint

03-Dec-2008 -  Icelandic generics firm Actavis plans to use Malta as a distribution hub for the supply of drugs to the emerging African pharmaceutical market, according to reports in the Maltese press.

News in brief

Qatar and Egypt plan new drug plant

03-Dec-2008 -  Qatar and Egypt are to set up a new drug manufacturing plant at a facility in Qatar, according to BusinessIntelligence. The new facility will begin by producing soluble drugs for the emerging Qatari and Egyptian drug markets.

Teva and Servier raided by EC

27-Nov-2008 -  European facilities owned by Israel’s Teva Pharmaceuticals and French drugmaker Servier are among the firms raided by the EC’s competition unit earlier this week, according to media reports. 

ScinoPharm’s easy-filter irinotecan gets US patent

26-Nov-2008 -  Taiwanese API maker ScinoPharm has been granted a US patent for new crystalline forms of irinotecan which are designed to allow for easier filtration during production processing.

Further twists in heparin scandal

26-Nov-2008 -  A member of the US Congress has called on the GAO to launch an investigation into the FDA’s handling of the heparin crisis, citing “unanswered questions concerning [the] deaths”.

AZ to slash more European jobs and ramp-up China investment

24-Nov-2008 -  AstraZeneca is to cut 1,400 jobs and close more manufacturing facilities by 2013, as it attempts to slim down in preparation for impending generic competition for some of its cornerstone drugs.

Asia to drive glycerin market out to 2015

13-Nov-2008 -  Demand for glycerin as an ingredient in pharmaceuticals, personal care and other products is expected to show brisk growth out 2015, when demand around the world is expected to reach 3.39 billion pounds, according to market research firm Global Industry Analysts. 

Taiwan’s biotech statute continues to attract global players

29-Oct-2008 -  Taiwan’s efforts to position itself as a major biotechnology hub received a further boost today with the opening of Merck KGaA’s dedicated technology training centre in Xizhi City, Taipei County. 

NAFDAC blacklists 22 drug fakers

28-Oct-2008 -  The NAFDAC has banned 22 firms that it says are involved in the manufacture of fake drugs from ever again selling pharmaceuticals in Nigeria, as part of a countrywide clampdown. 

Spotlight

ICH sends Q11 guidelines to EU, US & Japanese regulators

ICH sends Q11 guidelines to EU, US & Japanese regulators

The ICH has sent its Q11 guidelines on APIs to regulatory bodies in the US, European Union...

in-Pharmatechnologist.com's review of Interphex 2012

in-Pharmatechnologist.com's review of Interphex 2012

in-Pharmatechnologist.com was at Interphex 2012 in New York, US to launch the revamped version of our website and speak...

Effective controls still lacking for continuous processing says Interphex panel

Effective controls still lacking for continuous processing says Interphex panel

Continuous processing is still hamstrung by a lack of control systems and is not ready for specific...

BASF buys omega-3 maker Equateq citing pharma potential

BASF buys omega-3 maker Equateq citing pharma potential

BASF has bought omega-3 fatty acid maker Equateq, citing its pharmaceutical and dietary supplements businesses as key...

EMA outlines manufacturing quality docs for biologics trials

EMA outlines manufacturing quality docs for biologics trials

The EMA has published final guidelines on manufacturing quality documents needed for biologics entering clinical trials.