The US Food and Drug Administration (FDA) has issued a draft guidance on the measures pharmaceutical and other manufacturers should take to make sure imported FDA-regulated products are in line with federal statutes and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.
Pharmaceutical Product Development of the US is expecting to post a 12 per cent hike in revenues in 2009, helped by the recent opening of offices in Ireland and Singapore and new deals with Merck & Co.
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.
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.
Despite criticism in certain quarters, joint GMP inspections represent the best use of resources in an increasingly globalised market, according to the EMEA.
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.
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...
Drug raw materials maker Akron Biotechnology has selected Austin Chemical Company to help expand its client-base in the global biotech, pharmaceutical, and diagnostic industries.
The FDA has established its first permanent presence in Latin America by opening an office in Costa Rica as part of “Beyond Our Borders Initiative”, which has also seen the agency set up three sites in China.
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.
Australian drug development firm Cancer Therapeutics (CTx) has selected IDBS’ E-workbook and ActivityBase platforms to manage its global drug development programmes.
AstraZeneca has signed a five year deal with Infosys Technologies for “end-to-end” application maintenance services in areas such as manufacturing, supply chain, finance, human resources and other corporate functions.
The MHRA has renewed its approval of Almac’s facility in North Carolina, bringing an end to a busy and successful four months of inspections at the clinical services group’s facilities.
The European Union’s long-awaited reform of pharmaceutical regulations known as the ‘pharmaceutical package’ was unveiled yesterday after months of consultation and debate.
India’s Bilcare has expanded its clinical trial materials business in its own market with the opening of new packaging and storage capacity at its facilities in Pune, India.
Contract research organisation PRA International has signed an agreement with fellow US firm Frontage Laboratories to expand the range of laboratory services it can offer to its clients.
Canadian contract manufacturer PharmEng International has managed to trim down its costs once again, but is still feeling the pain associated with the opening of its new facility in Sydney, Nova Scotia, and posted a loss of over C$8m (€5m).
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.
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.
Postponement of this year’s CPhI and P-MEC India events for “security reasons” may be only the first impact of last week’s Mumbai terror attacks on the country’s outsourcing industry, according to PwC’s life sciences head Sujay Shetty.
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.
The US Food and Drug Administration has opened offices in three Chinese cities – Beijing, Shanghai and Guangzhou – to help improve the safety of medicines and ingredients imported into the US.
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.
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”.
Chinese CRO Tigermed Consulting has teamed up with Russian and South Korean counterparts OCT and LSK to establish a global clinical trials network and expand its geographic footprint.
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.
DPT Laboratories chose this year’s AAPS in Atlanta to showcase its research and development capability with a unique poster presentation examining the role of various excipients in nasal drug delivery applications.
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...
Barrack Obama’s election as US president has been roundly welcomed by India’s generics sector, despite his somewhat contradictory desire to reduce the level of outsourcing but not "shy away" from globalisation.
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.
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.
The pharmaceutical industry must adapt its processes and strategies to cope with a new, tougher operating environment, according to Stefan Borgas, CEO of Lonza.
Wyeth Medica, an Irish subsidiary of US drugmaker Wyeth, plans to cut 250 jobs at its manufacturing plant in Newbridge, County Kildare, according to media reports.
The International Pharmaceutical Excipients Council (IPEC) of Europe has outlined the actions it is taking as it continues to develop awareness of the need for safe excipients.
Canada’s Ethica Clinical Research has expanded into the emerging Latin American market via a joint venture with Argentinean contract research organisation Blanchard y Asociados.
Exclusive interview with IPEC China chairman Nevin Cheng
IPEC China must become a “harmonisation bridge between China and other countries,” according to Colorcon’s Nevin Cheng who was recently elected chairman of the new organisation.
Pharmaceutical companies in the developed world have already
shifted substantial manufacturing and clinical trial work to
emerging economies such as China and India, but a new study suggest
they are increasingly counting on these...
A US senator has asked the Food and Drug Administration (FDA) for a
probe into outsourcing of production for pharmaceuticals, as well
as ways to make drugmakers accountable for products which fail to
meet quality standards.
China is on course to having its own version of the International
Pharmaceutical Excipients Council - joining its fellow
organisations in Europe, the Americas and Japan.
The healthcare logistics industry is currently experiencing a shift
toward globalisation, supply chain simplification and delivery
specialisation, says an industry expert.
The US Food and Drug Administration (FDA) has revealed it will be
operating on the ground in China imminently, while the Drug
Information Association (DIA) has just planted itself in Asia's
other pharma don, India.
The US Food and Drug Administration (FDA) believes that the
contamination of Baxter's blood thinner heparin, which has been
linked to 62 deaths in the US, may have been due to the deliberate
replacement of some ingredients with...
At present India appears to be beating China in the race for Asia's
top clinical spot, according to new figures published by india´s
Planning Commission.
Despite all the hype over clinical trial offshoring, the US still
dwarfs the scene, with emerging countries as yet only a blip on the
radar, a unique new study reveals.
The pharmacopoeias of the US and China will work more closely
together in future in a bid to improve the quality of medicines
available in both countries.
Pharmaceutical manufacturers, distributors and retailers alike have
welcomed a unanimous vote by the California State Board of Pharmacy
to delay for another two years the implementation of electronic
pedigree requirements for tracking...
The globalisation of the supply chain increasingly challenges the
US Food and Drug Administration's ability to ensure the quality of
pharmaceuticals on the US market, acknowledges the acting director
of the agency's Center...
