Granules India gains after USFDA nod for migraine drug

Granules India rose 1.57% to Rs 326.90 after the company said that US drug regulator has approved its Abbreviated New Drug Application (ANDA) for Acetaminophen, Aspirin and Caffeine Tablets USP, 250 mg/250 mg/65 mg (OTC).

The product is bioequivalent to the reference listed drug product (RLD), Excedrin migraine tablets, 250 mg/250 mg/65 mg, of GlaxoSmithKline Consumer Healthcare.

The drug is indicated for treating migraine. The product will be manufactured at the company's Hyderabad facility and is expected to be launched shortly.

Priyanka Chigurupati, Executive Director, Granules Pharmaceuticals, Inc., commenting on the approval, said: "We are pleased to announce approval of acetaminophen, aspirin and caffeine tablets, emphasizing our focus on building sustainable OTC product portfolio in the US market. We received approval for this triple combination product within 14 months from filing. With this, we have received three ANDA approvals over the past month."

Granules now has a total of 38 ANDA approvals from US FDA (37 final approvals and 1 tentative approval).

Granules India is a growing pharmaceutical manufacturing company. The company produces finished dosages (FDs), pharmaceutical formulation intermediates (PFIs) and active pharmaceutical ingredients (APIs). The company's global presence extends to over 250 customers in 60 countries through offices in India, US, and UK.

On a consolidated basis, the drug maker reported 129.30% jump in net profit to Rs 146.81 crore on a 20% rise in net sales to Rs 844.51 crore in Q3 FY21 over Q3 FY20.

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