Global Drug Facility warns of a temporary delay on deliveries of quality-assured Capreomycin
The Stop TB Partnership's Global Drug Facility (GDF) anticipates a temporary shortage of quality-assured Capreomycin. This shortfall will affect GDF's ability to deliver orders in timely fashion and may limit its capacity to respond to emergency requests for the drug.
The shortfall has come about because the sole manufacturer currently eligible to produce Capreomycin has limited production capacity; and the only other eligible manufacturer has ceased production. There are ongoing efforts to increase production capacity; and GDF has urged approval of an additional manufacturing site. Provided the relevant regulatory authorities approve this manufacturer, supply constraints on Capreomycin should be mitigated in the near future.
At present GDF cannot provide a firm timeline on improvements in supply, but we will keep all partners updated as we receive new information.
Given limitations in the supply of Capreomycin, GDF advises countries to closely monitor their stocks and maintain close communication with their focal points in the Green Light Committee and GDF. In addition, in order to ensure the most optimal use of existing stocks, GDF strongly recommends that countries limit their procurement orders to stocks they will need for the next six months instead of ordering quantities needed for a full year. It is possible there will be delays in filling these orders because of the shortfall.
GDF will make every effort to respond to shortages and impending stock outs and will allocate Capreomycin to those countries in greatest need. GDF also will maintain regular contact with countries to get updates on stock levels and consumption data.
For further information or clarifications, please do not hesitate to contact GDF and GLC focal points, who will look at each case and provide specific recommendations.