The impact counterfeit pharmaceuticals can have on a company’s sales has been highlighted by Tongjitang Chinese Medicines’ (TCM) second quarter results.
Generic drugmaker Actavis Totowa has voluntarily recalled all drugs produced at its Little Falls, New Jersey manufacturing facility after an FDA inspection uncovered several breaches of current GMP codes.
Combined CMO and specialty pharmaceutical group Akorn hopes that deals signed this month with Bioniche Pharma and an as yet unidentified drugmaker will help its manufacturing division make up the ground lost in the last quarter.
Ranbaxy’s CEO has confidently asserted that the US Food and Drug Administration’s (FDA) court action will be dropped in the near future and fired another warning shot at the “negative elements” he believes were behind the controversy.
A deal to sell Pfizer's active pharmaceutical ingredient manufacturing (API) plant in County Cork, Ireland, has fallen through according to a statement by the US drug giant, placing over 180 production jobs under threat.
Contract research and production specialist Patheon is to promote
BSP Pharmaceuticals' cytotoxic development and manufacturing
services as part of a marketing agreement that the two firms have
signed.
2005 marked the real beginning of contract manufacturing in Japan,
which had been held back by an overly-cautious regulatory
environment and significant and unique quality and specification
demands in the marketplace.
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...
The heparin recall has widened after a lot of heparin sodium USP
active pharmaceutical ingredient (API) produced by Scientific
Protein Laboratories (SPL) was found to contain a heparin-like
contaminant.
Merck & Co has signed a $32m deal to evaluate MicroDose
Technologies' dry powder inhalation technology in the delivery of
some of its respiratory product lines.
More details have emerged over the US Food and Drug
Administration's (FDA's) failure to vet the Chinese manufacturing
plant implicated in the Baxter heparin scare - the agency mistook
it for an already-inspected plant, it...
Product recalls in the UK due to health and safety concerns have
shot up to their highest level, with the rise in outsourcing to
China finger pointed for much of the blame.
The first steps in tightening the safety controls on the
pharmaceutical ingredients imported to the US from China have been
taken following months of negotiations between the regulatory
bodies of the two countries.
The official report into good manufacturing practice (GMP) failures
that caused dangerous contamination and a Europe-wide recall of
Roche's HIV drug Viracept (nelfinavir) claims the firm simply did
not understand its own manufacturing...
As of next year Chinese pharmaceutical manufacturers will face a
tougher time gaining good manufacturing practice (GMP)
certification after the country's regulator signalled new and
stricter standards were on the way.
Following the recent news that pharma heavyweight Pfizer has also
been struck by contamination of its HIV drug Viracept (nelfinavir),
in-PharmaTechnologist.com spoke to the US Food and Drug
Administration (FDA) to find out how far...
Abraxis BioScience has snapped up another manufacturing plant in
its drive to expand production capabilities, this time announcing
the purchase of Watson Pharmaceuticals' sterile injectables plant.
Indian pharmaceutical manufacturing company Shasun Chemicals and
Drugs has now got its eye fully on the US market after recent
approval of its new formulation facility in Puducherry.
Just over a week after Roche was forced to initiate a Europe-wide
recall of HIV drug Viracept (nelfinavir), in-PharmaTechnologist.com
considers the contamination case and the pharmaceutical processes
blamed for the incident.
Batches of two fake blockbuster drugs are being recalled after
counterfeits made their way into the UK supply chain via parallel
distribution, adding fuel to the debate on the security of the
practice in the EU.
Varian has launched a new dissolution system specifically geared to
testing small drug volumes in medical devices such as implants or
drug-eluting stents.
Canadian-based consulting and contract manufacturing company
PharmEng International has built on an existing sourcing
arrangement with Bengbu Bayi Pharmaceuticals to secure exclusive
distribution rights to the Chinese company's...
Preclinical and early-phase drug discovery will be the next service
area to take off in India, Dr. Reddy's CEO GV Prasa predicted at a
conference yesterday.
US firm Abraxis BioScience has been issued a firm warning by the
Food and Drug Administration (FDA) following concerns about
contamination of drug products and marketing violations for several
drugs.
Actavis has waded further into India and picked up new contract
manufacturing capabilities along the way with the purchase of a
division of Sanmar Specialty Chemicals (SSCL).
Cardinal Health has reached an agreement with the US Food and Drug
Administration (FDA) on plans to resume manufacture and sale of its
Alaris (SE) line of infusion pumps. Units were seized and
production halted following grave safety...
Cardinal Health, the leading contract manufacturer for the
pharmaceutical industry, has announced its plans to sell its drug
manufacturing and packaging unit in order to focus on its
health-care business.
Biotech company Progen has decided to manufacture its new
anti-cancer drug in-house rather than outsource it in order to save
on costs after the FDA gave the thumbs up for the manufacture of
the drug for its upcoming phase III clinical...
Dragon International has announced its plans to acquire Jinguang
Pharmaceuticals, a manufacturer of Chinese herb medicines, in a bid
to get a first step into the burgeoning traditional Chinese herbal
medicine market.
Drug manufacturers having troubles complying with the FDA?s current
Good Manufacturing Practice (cGMP) regulations, may now have the
help they need thanks to a new white paper available on the
subject.
A year after it published its five-year strategy: Vision 2010 -
Building on Strengths - DSM's commitment is showing no sign of
slowing as is continues to invest in the expansion of its
pharmaceutical production capabilities around...
To escape stagnating growth, hospital supplies firm Hospira has
agreed to buy Australia's Mayne Pharma for $2bn (€1.56bn), creating
the world's biggest manufacturer of generic injectable drugs.
Portuguese drug producers are small and need to merge or form
alliances to compete at a global level, investing more in
innovation and increasing their competitiveness like custom
manufacturer Hovione has done, a new report by market...
Jacobs Engineering Group has inked a new contract with Boehringer
Ingelheim to provide technical and construction services for its
new bulk active pharmaceutical ingredient (API) facility being
built in Petersburg, Virginia, US.
Merck Sharp & Dohme (MSD) has invested $100m to expand its
manufacturing plant in Singapore, bringing the drug giant's
investment in this budding region to over S$1bn (€0.5bn).
UK government legislation designed to curb animal extremism appears
to be working as statistics published this week records a reduction
in the number of incidents provoked by animal rights extremists
during the first half of this...
Active pharmaceutical ingredient (API) manufacturers in Europe are
struggling to differentiate their capabilities and compete in an
outsourcing market suffering from overcapacity, diminishing
profitability and threats from Asia.
Drug delivery firm Egalet has asked SP Medical, a manufacturer of
moulded plastics and coatings, to make sufficient clinical grade
quantities of its therapeutics using injection moulding, which
allows for greater uniformity and reproducibility...
RSSL Pharma Training has established three new courses to help UK
pharmaceutical and medical device manufacturers prepare themselves
for a plant inspection by the US Food and Drug Administration
(FDA).
Registration is now open for the annual "Pharmaceutical Outsourcing
of Discovery Chemistry, Advanced Intermediates and API's"
conference, which this year celebrates its 10th anniversary.
Pfizer has sold a large manufacturing plant in Puerto Rico to
biopharmaceutical firm Abraxis for $32.5m (€25.4m), as it continues
to consolidate its manufacturing operations.
Watson Pharmaceuticals is selling its unprofitable injectables
manufacturing plant and pulling out of this market segment
altogether. The Company is now establishing contract manufacturing
agreements to take over the 15 products affected.
In its first venture outside the subcontinent, though certainly not
the last of its kind for India pharma companies, contract
pharmaceuticals manufacturer Kemwell has bought for an undisclosed
sum Pfizer's production plant in...
