The shares of Granules India - the Hyderabad based pharmaceutical manufacturing company, surged by over 8% in the backdrop of the company receiving approval from U.S. Food and Drug Administration (FDA) to its Methylergonovine 0.2mg Tablets.
Methylergonovine is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum hemorrhage.
The product Methylergonovine 0.2 mg tablet is a low competitive drug with sizable volumes and the launch of the product in India will in-turn benefit the company.
Food and Drug Administration-popularly known as FDA, is a federal agency of the United States Department of Health and Human Services.
The role of FDA is to protect and promote the public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs, vaccines and so on.
This approval has come from the company's US facility, which will start building a pipeline from its facility located in Virginia, US. The current facility in the United States is an acquired facility and the company has chalked out plans to start adding value-added products from this facility.
The company plans to develop around 5-6 Abbreviated New Drug Application (ANDA) per year. Once the company starts launching products from this site, there will be operating leverage which will lead to the expansion of margins.
The stocks of the company were trading at Rs 105.25 per piece, up by 8.79% at 12:58 pm (IST) in BSE.