US FDA reinforces import ban on Ipca Lab's API for chloroquine phosphate1 min read . Updated: 24 Jun 2020, 06:55 PM IST
USFDA has also informed that due to potential shortage implications and/or medical necessity
US Food and Drug Administration (FDA) on Wednesday reintroduced import ban on Indian Pharmaceutical Combine Association Limited (IPCA) Lab's active pharmaceuticals ingredients (APIs) for chloroquine phosphate.
The IPCA labs said that the US FDA vide its email dated 23rd June 2020 has communicated to the Company that shortage implications for Chloroquine Phosphate API has changed and Chloroquine Phosphate drug product is no longer in shortage and therefore, no shipment of API Chloroquine Phosphate will be excluded from the import alert.
USFDA has also informed that due to potential shortage implications and/or medical necessity, exception to the import alert has been made for API Hydroxychloroquine Sulfate. US FDA has further informed that this exception will be re-considered if the shortage implications change, the company said.