Zydus Cadila, one of India’s largest pharmaceuticals manufacturers, said it got the the final approval from the US Food and Drug Administration to market Bumetanide, used to treat swelling.
The drug is used for treating edema, or the swelling of legs, feet, hands or other parts due to the accumulation of excessive fluid in the tissues.
The edema that occurs in diseases of the heart, liver, and kidneys is mainly caused by salt retention, which holds the excess fluid in the body
Bumetanide, said Zydus Cadila, is used in patients suffering from congestive heart failure, hepatic and renal disease, including the nephrotic syndrome.
Three doses have been approved — 0.5 mg, 1 mg and 2 mg.
The tablets will be manufactured at the group’s manufacturing facility at Baddi.
Zydus said it now has more than 185 approvals and has so far filed over 320 ANDAs since the commencement of the filing process in FY 2003-04.
The company develops, manufactures and markets a broad range of healthcare therapies.
It is headquartered at Ahmedabad in Gujarat and employs over 21,000 people worldwide.
It is the fourth largest pharmaceutical company in India.
Cadila was founded in 1952 by Ramanbhai Patel (1925–2001), formerly a lecturer in the L.M. College of Pharmacy, and his business partner Indravadan Modi.
In 1995 the Patel and Modi families split, with the Modi family’s share being moved into a new company called Cadila Pharmaceuticals Ltd. and Cadila Healthcare became the Patel family’s holding company.
In 2015, Cadila Healthcare acquired German Remedies.