Granules India spurts after USFDA approval for generic

Granules India rose 9.35% to Rs 105.80 at 11:05 IST on BSE after the company said that it received US drug regulator's approval for generic Methylergonovine tablets.

The announcement was made before trading hours today, 17 May 2018.

Meanwhile, the S&P BSE Sensex was down 89.05 points, or 0.25% to 35,298.83.

On the BSE, 5.17 lakh shares were traded in the counter so far compared with average daily volumes of 2.30 lakh shares in the past two weeks. The stock had hit a high of Rs 106.30 and a low of Rs 97.65 so far during the day. The stock hit a 52-week high of Rs 157 on 18 May 2017. The stock hit a 52-week low of Rs 91.30 on 14 May 2018.

Granules India announced that the US Food and Drug Administration (USFDA) has approved its Abbreviated New Drug Applications (ANDA) for Methylergonovine 0.2 mg tablets. The ANDA was filed by Granules Pharmaceuticals Inc., a wholly-owned subsidiary of Granules India. The approved ANDA is the bioequivalent to the reference listed drug product (RLD), Methergine 0.2 mg. Methylergonovine is a semisynthetic ergot alkaloid used for the prevention and control of postpartum haemorrhage.

On a consolidated basis, net profit of Granules India declined 10.34% to Rs 35.02 crore on 16.30% rise in net sales to Rs 410.73 crore in Q3 December 2017 over Q3 December 2016.

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

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