Granules receives USFDA approval for Acetaminophen 650 mg

Granules announced that the USFDA has approved its ANDA for Acetaminophen 650 mg tablets, extended-release, bioequivalent to the reference listed drug product Tylenol 650 mg tablets, extended-release.

Acetaminophen 650 mg extended-release tablets are used primarily for temporary pain management including arthritis relief. The addition of Acetaminophen 650mg, extended-release tablets to OTC portfolio leverages several components of Granules' value proposition. Granules’ is the only supplier that is backwards integrated up to the API on this product. The company’s vertically integrated approach will enable it to provide high quality, cost-efficient products that benefit consumers. With a capacity of over 24,000 mt/year of Acetaminophen AM and finished dosage capacity of more than 18 billion units/year, the company believes it will increase its market share significantly.

In Q3FY19, Granules net sales stood at Rs. 631.78 crore, up 53.82 per cent YoY. The company’s quarterly net profit stood at Rs. 60.32 crore in December 2018, up 72.26 per cent from Rs. 35.02 crore in December 2017.

On Thursday, Granules was trading at Rs. 113.75 per share, down 0.18 per cent on the BSE.