NEW DELHI: Drug firm Jubilant Life Sciences said it has received approval from the US health regulator for its 0.9 per cent Sodium Chloride injection, used for diluting or dissolving drugs, in the American market.
The company’s subsidiary Jubilant HollisterStier LLC, has received abbreviated new drug application (ANDA) approval for 0.9 per cent Sodium Chloride injection USP, 3 mL and 10 mL vials, Jubilant Life Sciences said in a BSE filing.
The company’s injection is the generic version of Hospira Inc’s Sodium Chloride 0.9 per cent injection in plastic container, it added.
The product is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, Jubilant Life Sciences said.
“This is the first ANDA approval in injectables received by the company. We have filed two injectables and one ophthalmic product as on March 31, 2016,” the company said.