Granules India receives USFDA approval for Metformin Hydrochloride ER tablets

Granules India Limited today announced that United States Food & Drug Administration (USFDA) has given the final approval for its abbreviated new drug application (ANDA) for Metformin Hydrochloride extended-release tablets USP, 500 mg and 1,000 mg. These tablets are the generic equivalent of Glumetza ER tablets, 500 mg & 1,000 mg of Bausch Health US LLC. 

These tablets are indicated as an adjunct to diet and exercise and improve glycaemic control in adults with type 2 diabetes mellitus. 

Reacting to this, the stock of Granules today jumped 2.84 per cent and made an intraday high of Rs 371.75 per share. 

The company now has a total of 35 ANDA approvals from USFDA, out of which, 34 are final approvals and 1 is tentative approval. 

The company reported a net profit of Rs 163.63 crore in Q2FY21, an increase of 70.82 per cent. It had reported a profit of Rs 95.79 crore in Q2FY20. The company reported net sales of Rs 858.12 crore for Q2FY21, an increase of 22.67 per cent as against the net sales of Rs 699.53 crore for Q2FY20. 

Granules India is a pharmaceutical manufacturing company, which produces finished dosages (FDs), pharmaceutical formulation intermediates (PFIs) and active pharmaceutical ingredients (APIs). The company has a presence in 60 countries through offices in India, the US, and the UK. 

According to BSE data, the stock traded at a P/E multiple of 15.72 and a price-to-book ratio of 4.73. The stock has a 52-week high and a 52-week low of Rs 438 and Rs 114.50, respectively. 

At the time of market closing, the stock of Granules India Ltd was trading at Rs 368.45, up by 1.92 per cent on BSE.