Caplin Steriles gets green signal for Sumatriptan injection by USFDA

Caplin Point Laboratories Limited’s subsidiary, Caplin Steriles Limited has been granted final approval from United States Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Sumatriptan injection.  

Adults, who suffer from migraine with or without aura, can be treated by Sumatriptan injection USP, 6 mg/0.5 ml (12 mg/ml) single-dose vials. The treatment of cluster headache is also possible with the injection.

It’s a generic therapeutic equivalent version of (RLD), Imitrex injection of GlaxoSmithKline, USA. 

According to IQVIATM (IMS Health), for the trailing 12-month period that ended on March 2021, Sumatriptan injection had sales of nearly $5 million in the US. 

Caplin Steriles Ltd is a company that is focussed on the manufacturing of sterile. It has been approved by USFDA as well as EU-GMP. The company has progressively developed and filed 20 ANDAs in the US, out of which, it got approval for 16. The company plans on expanding its product portfolio to 35 injectable and ophthalmic products in the upcoming four years. 

Today at 2.42 pm, the parent company’s stock was trading at Rs 691.75, barely up by 0.33 per cent from its previous close on BSE. The stock has a 52-week high & low of Rs 722.70 and Rs 345.40, respectively.