The shortage of iodinated contrast media is no longer a less-known matter. The FDA (Food and Drug Administration), the USA has recently granted Bayer’s permission for importing Ultravist from other countries to dissipate the impact of the ongoing shortage.
According to Bayer’s communications, Ultravist, intended for the USA market, and the contrast agent share a common manufacturing site, which is in Berlin, Germany. However, the contrast agent lacks the labeling of FDA approval as it was for cross-country distribution.
The Shortage Problem
The iodinated contrast media shortage has impacted the US market gravely. The growing agitation resulting from this shortage has stirred the US market at every level. According to experts, the COVID 1 crisis and the mobility restrictions hampered the smooth flow of production.
Therefore, the usual supply of these agents went down considerably. To manage the situation, the United States Food and Drug Administration has collaborated with Bayer to import a restricted quantity of Ultravist® (iopromide) to fill the gap between demand and supply. Originally this stock was for foreign markets.
The Solution
Contrast media shortage is undoubtedly a significant issue for the healthcare sector. Finding a solution to this problem was necessary. Hence, mitigation measures involving the suppliers and the imaging organizations were obligatory.
Last spring, the Shanghai manufacturing unit of GE, the United States’ most critical supplier of iodinated contrast media, announced a shutdown following the COVID 19 measures. However, the USA market expected the matter to resolve by June.
However, the supply shortage continued to wreak havoc on the market even after mid-July. Experts suggested that this shortage remain unaltered through September.
However, the updates issued by GE on July 15 affirmed their full-capacity production at the Shanghai facility. However, they also mentioned that they are anticipating inadequate availability of contrast media since they are trying to stabilize the global supply issue.
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