IPCA Labs says USFDA removes import alert exemption on hydroxychloroquine sulphate

Ipca Laboratories on Thursday (2 July) said that US drug regulator has is removing the exemption given to the drug maker from the import alert for API and formulation of hydroxychloroquine sulphate.

The US Food and Drug Administration (USFDA) on 1 July 2020 informed Ipca Laboratories that the shortage implications for hydroxychloroquine sulphate has changed and that it has been removed from list of drug products in shortage. Hence, the USFDA is removing the exemption given to the company from the import alert for API (active pharmaceutical ingredient) and formulation (finished products) of hydroxychloroquine sulphate.

In March 2020, USFDA exempted import alert on chloroquine phosphate and hydroxychloroquine sulfate APIs manufactured in IPCA Laboratories' APIs manufacturing unit at Ratlam (Madhya Pradesh) and hydroxychloroquine sulphate tablets produced at the company's formulations units at Pithampur (Madhya Pradesh) and Piparia (Silvassa). USFDA had said that it would reconsider the exemptions if the shortage implications change.

Later on 23 June 2020, USFDA informed the company that shortage implications for chloroquine phosphate API 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.

Shares of IPCA Laboratories were up 0.08% to Rs 1642.95 on BSE. The scrip hovered in the range of Rs 1,629 to Rs 1,683.95 so far.

IPCA Laboratories' consolidated net profit fell 13.5% to Rs 83.05 crore on 22.1% rise in net sales to Rs 1,073.76 crore in Q4 March 2020 over Q4 March 2019.

IPCA Laboratories is a vertically integrated pharmaceutical company. It produces finished dosage forms and active pharmaceutical ingredients.

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