Ipca gets US FDA nod on Hydroxychloroquine Tab

New Delhi, June 19 (UNI) Ipca Laboratories Ltd has announced that it has received approval from US Food and Drugs Administration (FDA) to market Hydroxychloroquine Sulfate Tablets USP - 200 mg in the US market.

Total annual market sales for Hydroxychloroquine Sulfate tablets in US were 50 millions dollars, a statement said.

Ranbaxy Pharmaceuticals Inc (Ranbaxy), based in Jacksonville, Florida USA, will commercialise this product in the US market utilising its established marketing expertise and distribution network, added the statement.

This is now the third product to receive US FDA approval for marketing under the Ipca's alliance with Ranbaxy after Furosemide and Atenolol tablets.

According to the arrangement, Ranbaxy will initially manufacture and market this formulation in the US healthcare system using the company's DMF approved Active Pharmaceutical ingredient (API) - Hydroxychloroquine Sulfate.

In future, the company will manufacture this formulation utilising its facilities in India.

Ipca is setting up a new formulations manufacturing facility meeting US regulatory requirements at a SEZ in Indore.

UNI