Sun Pharmaceutical Industries receives USFDA Approval
DSIJ Intelligence / 11 Apr 2016
Sun Pharmaceutical Industries (SPIL) bagged USFDA approval for BromSite, non-steroid drug used to treat inflammation and prevent pain in patients undergoing cataract surgery.
Sun Pharmaceutical Industries (SPIL) bagged USFDA approval for BromSite, non-steroid drug used to treat inflammation and prevent pain in patients undergoing cataract surgery. The company’s wholly-owned subsidiary has received approval from USFDA for its New Drug Application (NDA) related to BromSite (bromfenac ophthalmic solution) 0.075 per cent for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery.
The drug has been developed by InSite Vision, a company that had been acquired in November 2015. It is likely to commercialize BromSite through its newly formed US-based division Sun Ophthalmics in the second half of 2016.
According to IMS MAT January 2016, the US NSAID (Nonsteroidal anti-inflammatory drugs) ophthalmic market increased by 8 per cent, generating around USD 400 million in sales and about 4 million prescriptions. As per the USFDA, NDA application is the vehicle through which drug sponsors formally propose that the FDA should approve a new pharmaceutical for sale and marketing in the US. Sun Pharma is the world's fifth largest speciality generic pharmaceutical company and India's largest drug maker.
On financial front, SPIL’s consolidated revenue increased by 3.58 per cent to Rs 7082 crore in Q3FY16 as compared to previous quarter. The company’s EBITDA too rose by 12.17 per cent to Rs 2169 crore in Q3FY16 on a quarterly basis. Its Net Profit also boosted by 28.01 per cent to Rs 1417 crore in Q3FY16 as compared to previous quarter.
The share price of SPIL increased by 1.74 per cent on bourses in early trades; and is trading at Rs 815 on an intraday basis.
SPIL is India's top pharmaceutical company. The company provides high-quality, affordable medicines trusted by customers and patients in over 150 countries across the world. Its global presence is supported by 49 manufacturing facilities spread across 6 continents; R&D centres across the globe; and a multi-cultural workforce comprising over 50 nationalities. SPIL’s footprint across emerging markets covers over 100 markets in and 6 markets in Western Europe.
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