Granules India rises on USFDA approval for migraine drug

A pharmaceutical manufacturing company, Granules India announced on Wednesday that it has received an abbreviated new drug application (ANDA) approval for Acetaminophen, Aspirin, and Caffeine tablets USP from USFDA.

The drug Acetaminophen and Aspirin in the strength of 250 gm each along with Caffeine tablets USP (65 mg) is bioequivalent to Excedrin Migraine tablets of GlaxoSmithKline Consumer Healthcare (GSK CH). Acetaminophen, Aspirin, and Caffeine tablets are used in the treatment of migraine. 

The drug will be manufactured in the company’s Hyderabad facility, which is expected to be launched in the near term. Acetaminophen, Aspirin, and Caffeine tablets emphasises the company’s focus on building sustainable OTC product portfolio in the US market. 

Granules India business is bucketed into three areas namely, the core business, which comprises core molecules like Paracetamol, Ibuprofen, Metformin, Guaifenesin, and Methocarbamol. The emerging business that focusses on manufacturing APIs with a focus on vertical integration and the third is CRAMS segment, which focuses on contract research & manufacturing. 

The company’s revenue comprises 52 per cent from the API segment, 16 per cent from the pharmaceutical formulation intermediates (PFI), 31 per cent from API and 1 per cent from other segments. 

At 2.32 pm today, its share was trading 0.54 per cent higher at Rs 323.60. The share recorded an intraday high & an intraday low of Rs 329 & Rs 319, respectively on BSE.