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Industry has key role to play in COE anti-counterfeiting treaty

16-Jun-2010 - The role of the pharma industry in supporting the COE anti-counterfeiting treaty, which aims to criminalise activities, “cannot be underestimated”, according to a directorate member.

BioScale wins funding to develop protein analytics tech

15-Jun-2010 - BioScale has secured $25m (€21m) to fund commercialisation of its ViBE protein analytics systems.

USGS suspects pharma facilities polluting waters

10-Jun-2010 - Water used by pharmaceutical manufacturing facilities is being released into the environment with drug concentrations that are up to 1000 times higher than normal according to a study conducted by the US Geological Survey (USGS).

KV sells unit in $24.6m deal

08-Jun-2010 - KV Pharmaceuticals has decided to cut its losses and sell its subsidiary Particle Dynamics in a deal worth $24.6m (€20.6m). The deal adds some much needed stability as the business attempts to shore up its finances during a difficult period.

Caraco work plan gains FDA approval; begins rehiring

07-Jun-2010 - Caraco’s work plan setting out remedial actions needed to restart production at its Detroit-based plant has been approved by the FDA.

NAFDAC keen on new SMS anti-counterfeit results

03-Jun-2010 - An anti-counterfeiting pilot project in Nigeria, which uses a mobile authentication service (MAS) to validate genuine medication, has completed a 100-day pilot phase. Preliminary results suggest the scheme is well on the way to becoming an effective defence against counterfeit drugs and other products.

Cambrex receives FDA approval for Iowa site

03-Jun-2010 - American chemicals maker Cambrex has announced its active pharmaceutical ingredient (API) manufacturing facility has completed a successful FDA inspection.

USP forges stronger links with Ukraine and Russia

03-Jun-2010 - The USP is strengthening links with Eastern Europe and Russia by agreeing to share quality standards with Ukraine and offering training courses in Moscow.

Claris’ manufacturing practices under FDA scrutiny

02-Jun-2010 - Indian-based drug makers continue to come under intense scrutiny by the US Food and Drug Administration (FDA) as the regulatory body issues warnings to healthcare professionals not to use certain brands of antibiotics due to potential contamination.

$175m fine for Genzyme after Allston troubles

25-May-2010 - US biotech Genzyme will pay $175m and cease some manufacturing operations at its facility in Allston, Massachusetts under final terms of Food and Drug Administration (FDA) consent decree.

US FDA should disclose more about site inspections, says taskforce

20-May-2010 - The US FDA should change its disclosure policy relating to manufacturing site inspections according to new draft recommendations by the Department of Health and Human Services (HHS) Transparency taskforce.

Eisai opens manufacturing & development site at RTP

20-May-2010 - Eisai has opened a $100m (€81m), 65,000 sq ft commercial manufacturing and drug development site for intravenous treatments in Research Triangle Park (RTP), North Carolina, US.

India, Thailand call on WHO to focus on quality not IP

19-May-2010 - India and Thailand have requested the WHO ends its involvement with IMPACT, which the countries believe has conflicts of interest, and begin a programme focused on quality, safety and efficacy.

Halozyme concerned about Baxter’s quality and capabilities

18-May-2010 - Concerns about the quality and capabilities of Baxter’s manufacturing operations have led to Halozyme issuing a notice of breach and stating it may terminate their Hylenex relationship.

IFMPA puts patients at heart of counterfeit drug fight

12-May-2010 - The IFMPA says that patients are the real victims of counterfeiters and has asked drugmakers to put this at the heart of their fight against fakers.

J&J halts production at Pennsylvania after FDA QC criticism

06-May-2010 - Healthcare major Johnson & Johnson (J&J) has suspended operations at a Pennsylvania plant linked to a major product recall after US FDA inspection.

Independent expert finds KV site in compliance with GMP

05-May-2010 - KV Pharmaceutical has reported that an independent expert has re-inspected its facility and found it to be in compliance with good manufacturing practices (GMP).

USTR lists counterfeit drug hotspots in annual report

03-May-2010 - The Office of the United States Trade Representative (USTR) has expressed particular concern about the proliferation of counterfeit drugs in countries including Brazil, China, India, Indonesia and Russia.

Mitsubishi Tanabe CEO quits JPMA role after manufacturing ban

28-Apr-2010 - Manufacturing problems at Mitsubishi Tanabe Pharma (MTP) have forced CEO Michihiro Tsuchiya to relinquish his vice presidency of the Japanese Pharmaceutical Manufacturers Association (JPMA).

USP, FDA must be proactive in updating monographs

27-Apr-2010 - The USP and FDA must work to identify counterfeited or intentionally adulterated products before they enter the healthcare system by collaborating on the modification of monographs, according to Margaret Hamburg.

Eruption of new technologies at Interphex 2010

22-Apr-2010 - Delegates lucky enough to have made the trip to Interphex 2010 in New York, US bore witness to the launch of a wide range of new drug manufacturing technologies with products by O'Hara, Corning and PTI being some of the highlights.

Map of India’s bulk drug and formulation facilities

19-Apr-2010 - in-PharmaTechnologist presents exclusive interactive maps of pharma manufacturing facilities in India, detailing the number of bulk drug and formulation facilities in each region of the country.

News in brief

Ranbaxy recalls Dewas-made antibiotic in US

19-Apr-2010 - More Dewas-related problems for Ranbaxy as the Indian generic drugmaker recalls an antibiotic in the US.

GE launches logger with extended temperature range

15-Apr-2010 - GE Sensing and Inspection Technologies has introduced an logger capable of covering a temperature range from -85ºC to 140ºC to provide a single tool for a variety of applications.

SFDA finds vaccines with insufficient API, says Simcere

06-Apr-2010 - The Chinese SFDA has found that four batches of rabies vaccine produced by Jiangsu Yanshen contained insufficient quantities of API and is investigating the conduct of some employees, according to Simcere.

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