In furtherance to letter dated 21st March, 2020 intimating USFDA exemption from import alert for APls Chloroquine Phosphate and Hydroxycholoroquine Sulfate manufactured from Company's APls manufacturing facility situated at Ratlam (M.P), Ipca Laboratories has now informed that the USFDA 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 hat due to potential shortage implications and/ or medical necessity, exception to the import alert has been made for API Hydroxychloroquine Sulfate. USFDA has further informed that this exception will be re-considered if the shortage implications change.
The above information is a part of company’s filings submitted to BSE.
