The discovery of a new batch of counterfeit drugs circulating in
the US market adds urgency to ongoing efforts to improve
traceability in the medicines supply chain, and will also lend
weight to arguments against parallel trade in...
France's Valois will launch a new-generation dispensing pump that
should improve the accuracy of drug dosing into the nasal passages
at the Interpack show later this week, reports Phil Taylor.
The US Food and Drug Administration (FDA), under fire of late for
an alleged failure to properly ensure prescription drug safety, set
out its stall at last week's Food and Drug Law Institute meeting,
saying that it is increasingly...
As the US Food and Drug Administration continues its deliberations
on generic biopharmaceuticals, the industry body representing
generic drug manufacturers has said that the time has now come for
the agency to make some hard decisions,...
The consolidation of the generic drugs industry continues, with
Novartis' unit Sandoz merging with two companies that will bring it
back into the number one position in the sector.
The Generic Pharmaceutical Association (GPhA) has praised the Food
and Drug Administration for validating the science of generic
biopharmaceuticals and making significant progress in establishing
requirements to approve these medicines.
Thomson Scientific & Healthcare has launched a new service to
allow pharmaceutical companies to quickly create and modify drug
labels that comply with new US Food and Drug Administration
guidance due to come into play this year.
Material science company Malvern Instruments has teamed up with
ImageTherm Engineering to develop a new version of an instrument
used to measure the size of droplets in concentrated spray and
aerosols.
Franklin Miller has launched a shredding system designed for the
efficient destruction of pharmaceutical materials, making it easier
for drug companies, distributors or wholesalers sitting on a pile
of expired medicines to dispose...
This week has seen several companies unveil significant capital
investments in new production and research units, and once again
production facilities for biological drugs - currently said to be
suffering from undercapacity - feature...
The Generic Pharmaceutical Association (GPhA) has urged the US Food
and Drug Administration (FDA) to move forward to accelerate the
approval of affordable generic versions of biopharmaceutical drugs.
Lloyd's Register Serentec has formed a new practice group to
provide process analytical technology (PAT) services to
pharmaceutical manufacturing clients worldwide.
Unichem Laboratories of India, a major supplier of active
pharmaceutical ingredients (APIs) and finished pharmaceuticals in
the country, has entered into an alliance that could see it
supplying generics into the US market.
The US Food and Drug Administration has stepped up its activities
in combating drug counterfeiting by bringing charges against drug
wholesalers for failing to carry out measures designed to safeguard
the pharmaceutical supply chain.
LINPAC Materials Handling has introduced a reusable container -
designed for pharmaceuticals and food and beverages - that could
allow companies to significantly reduce their shipping costs,
claims the company.
Germany's Boehringer Ingelheim has completed the validation process
for its new biopharmaceutical production plant in Biberach with a
positive inspection by the US Food and Drug Administration (FDA).
New York Attorney General Elliot Spitzer has continued in his
crusade to investigate pharmaceutical company practice by
requesting information from Forest Laboratories which is accused of
promoting its products for "off-label"...
A coalition of biopharmaceutical companies and regulatory agencies
has agreed on an electronic data standard that should make it
easier to file product approval dossiers to regulators
electronically, bringing drugs to market more...
German pharmaceutical and chemicals supplier Merck KGaA has set up
a new business unit to try and establish how some of the company's
pigments can be used as brand protection technologies.
The current rate of growth in the world generics market puts it on
pace to outgrow branded pharmaceuticals, which will only grow by
single digits in 2004, according to business intelligence firm
Cutting Edge Information.
A UK-based specialist in antimicrobial coating technology, BioCote,
has entered into an agreement with Comark to develop more hygienic
handheld thermometers and data loggers. The new products are
intended for use in the pharmaceutical...
3M has launched an updated version of its Integrated Packaging Tool
software that brings it into compliance with the US Food and Drug
Administration's 21 CFR Part 11 regulations on electronic
record-keeping, used to generate...
India's Dishman Pharmaceuticals and Chemicals has set up a company
specialising in the contract manufacture of active pharmaceutical
ingredients (APIs) and intermediates that is specifically aimed at
winning business from foreign...
The US Food and Drug Administration is to develop a blueprint for
speeding up the approval of new medical products to counteract the
slowdown in R&D productivity in the pharmaceutical industry,
writes Phil Taylor.
BioProgress of the UK, which makes cellulose based films for
coating tablets and capsules, is planning to buy a company which
would provide a rapid route to increase production capacity in the
US, and also accelerate the development...
UK tablet press and coating machine specialist Manesty will
introduce another product in its Xpress range at the TOTAL 2004
show next month as it navigates the sea-change in its business that
has emerged over the last few years.
A US programme aimed at shortening the development time for new
pharmaceutical and biological drugs - which involves close
collaboration between the Food and Drug Administration and the
developer - is now underway.
Akzo Nobel unit Diosynth has unveiled plans to cut 70 jobs at its
UK subsidiary based in Fife, Scotland, because strong competition
from Asian competitors is hitting the business.
CCL Label, a US firm specialising in the packaging and labelling of
pharmaceutical and consumer products, has forged an alliance that
could see so-called 'track and trace' technologies more widely
applied to the healthcare...
Bar code scanning systems, which scan medications and patient
identification bracelets at hospital bedsides to verify patients
are receiving the correct medications, were voted the top choice
for preventing medication errors in a...
US packaging specialist Advantek has sold its Vaculok range of
vacuum-insulated panels to MOCON, an instrumentation company
serving the medical, pharmaceutical and food industries.
Israel's Teva plans to buy Sicor in a €2.9bn deal that will create
a powerhouse in generic pharmaceuticals and active pharmaceutical
ingredient manufacturing.
Ireland's Elan Corp has signed up another heavyweight partner -
Janssen - for its NanoCrystals technology, designed to improve the
solubility of drug compounds.
The US Food and Drug Administration has issued its final guidance
document describing its current thinking regarding the scope and
application of 21 CFR Part 11 on electronic records and electronic
signatures; also unveils a series...
Akzo Nobel received a knock-back from the US Food and Drug
Administration after the agency asked for more information before
approving a ready-to-use version of the firm's fertility drug
Follistim.
The market for cell culture products is getting a lift from
stringent regulations from the US FDA and Department of
Agriculture, restricting the importation and usage of foetal bovine
serum
As regulators increase their scrutiny of manufacturing and quality
control, the key to avoiding non-compliance notices lies in
well-trained, knowledgeable personnel, says new report.
As this edition of In-pharmatechnologist.com goes online, the US
Food and Drug Administration is convening the inaugural meeting of
its Advisory Committee for Pharmaceutical Science's Manufacturing
Subcommittee.
Attendance at SupplySide East earlier this month was slightly up on
last year, according to organisers, and although there were few
product launches, the conference provided all the drama.
Patient safety, care quality, and efficiency in the supply chain
are likely to improve with new proposals from the US Food and Drug
Administration (FDA) that will require bar coding on medications.
Amarin corporation this week confirmed that its Swedish subsidiary
Amarin Development AB, as part of an agreement with Watson
Pharmaceuticals, has developed a generic formulation of glipizide
extended release tablets.
The US Food and Drug Administration announced this week that it has
accomplished the initial objectives outlined in its ongoing
initiative to modernise the agency's regulation of pharmaceutical
manufacturing and product quality.
