Chloroquine Phosphate API of Ipca Labs under USFDA import alert

In March 2020, United States Food and Drug Administration (USFDA) had made an exception to the import alert for some of Ipca Laboratories’ active pharmaceutical ingredients (APIs) and finished products (formulations). It included Hydroxychloroquine Sulphate and Chloroquine Phosphate APIs as well as Hydroxychloroquine Sulphate tablets.

This exception was made due to the shortage implications and medical necessity of certain drugs and finished products. Though these drugs are not approved for treatment of COVID-19 by any regulatory authority; many reports and research papers claimed that Chloroquine Phosphate and Hydroxychloroquine Sulphate formulations has a potential to treat COVID-19. Thus, the urgent demand for Chloroquine Phosphate and Hydroxychloroquine Sulphate APls and its formulations, from several countries, increased significantly, leading to the shortage.

However, the USFDA has now informed Ipca Lab that the shortage implications for Chloroquine Phosphate API have changed and Chloroquine Phosphate drug product is no longer in shortage so, no shipment of API Chloroquine Phosphate will be excluded from the import alert. However, due to a potential shortage, exception to the import alert for Hydroxychloroquine Sulphate continues.

The said APIs are produced at Ipca’s API manufacturing unit situated at Ratlam (Madhya Pradesh) while, Hydroxychloroquine Sulphate tablets are produced at the manufacturing units situated at SEZ Indore and Pithampur (Madhya Pradesh) and Piparia (near Silvassa in Madhya Pradesh). To meet the shortage of demand, the company had geared up its manufacturing and supply capacities. Despite the crisis and import alert, Ipca got an opportunity to supply these specific APIs to other countries, which are facing shortage.

On Wednesday, the stock of Ipca Lab dipped 2.9 per cent in the early morning session to Rs 1,623.85 from its previous close of Rs 1,671.85 on BSE.