Aurobindo receives final USFDA approval for Guaifenesin tablets

Aurobindo Pharma has informed the exchanges on receiving final approval from the US Food & Drug Administration (USFDA) for Guaifenesin tablets.

The drug controller has approved of Aurobindo to manufacture Guaifenesin extended-release tablets, 600 mg and 1200 mg (OTC). The company's Guaifenesin extended-release tablets are the AB rated generic equivalent of RB Health (US) LLC's Mucinex tablets. The product is expected to be launched in Q4FY20.

Guaifenesin extended-release tablets helps to loosen phlegm (mucus), and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. The mentioned product has an estimated market size of $ 301 million for the twelve months ending July 2019, as per the database of IRI.

Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.

The shares of Aurobindo Pharma on Thursday opened at Rs. 478 as against Wednesday's close of Rs 476.25 per share on the BSE. At 12:04 hours the stock was trading flat at Rs 473.35, 0.71 per cent down. The stock hit an intraday high of Rs. 483.20 and intraday low was Rs. 467.70. Its 52-week high was Rs. 838 and 52-week low was Rs. 435 per share on the BSE.