Failure to establish system suitability testing for heparin and heparin-related drugs has landed Shandong Analysis and Test Center a US FDA warning letter.
Heparin production may be moving back to Europe according to the EFCG, which cited the opening of Pharma Action’s processing plant as an indication that API buyers value quality and compliance throughout the supply chain.
From Thursday onwards all formulations of the blood thinner heparin shipped in the US will be only 90 per cent the strength of previous version, according to the FDA.
Baxter International says Pfizer supplied the bulk API used in a batch of Heparin linked to two patient deaths in Delaware, US last week, amid concerns of a repeat of last year’s contamination scandal.
Following fresh criticism of the agency’s handling of the heparin case, in-PharmaTechnologist reports on a FDA official’s explanation of the what, the when and the why of the scandal, from first deaths to continued vigilance.
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”.
US Marshals have entered Celsus Laboratories to seize 11 lots of heparin, which contain contaminated material from China according to the US Food and Drug Administration (FDA).
US researchers have developed a chemoenzymatic strategy to synthesise the anticoagulant drug heparin and avoid the contaminant that has killed more than 80 people.
APP Pharmaceuticals, currently the sole supplier of therapeutic heparin vials to the US market, has received FDA approval to manufacture three new formulations of the blood-thinner at its plant in Barceloneta, Puerto Rico.
The US Food and Drug Administration has declared the country's
previously-tainted heparin supply to be "safe" due to
stronger testing and controls that are now in place. Meanwhile,
China continues to distance itself...
Swedish authorities have recalled Sanofi Aventis' low molecular
weight injectable blood thinner Lovenox (enoxaparin), known locally
as Klexane, after four batches of the blockbuster drug were found
to contain oversulfated chondroitin...
The US Food and Drug Administration (FDA) has revealed evidence
linking the heparin contaminant with the series of reported adverse
reactions, and has also now issued a warning letter to the Chinese
facility at the centre of the safety...
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 number of people whose deaths are associated with an allergic
reaction to heparin has shot up as the US Food and Drug
Administration (FDA) has updated its tally.
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.
A US Food and Drug Administration (FDA) investigation into the
recent Baxter heparin scare has uncovered a contaminant in the
product that was sourcing the active pharmaceutical ingredient
(API) from a Chinese manufacturer.
France's Sanofi-Synthelabo has announced plans to sell two of its
products to GlaxoSmithKline in a deal which forms part of its
strategy to take over Aventis.
