Zydus Cadila gets USFDA nod for generic Misoprostol tablets to treat ulcers
New Delhi: Drug firm Zydus Cadila Wednesday said it has received the final nod from the US health regulator to market its generic Misoprostol tablets used for preventing stomach ulcers.
The company has received final approval from the United States Food and Drug Administration (USFDA) to market Misoprostol tablets in the strengths of 100 mcg and 200 mcg, Zydus Cadila said in a statement.
The drug will be manufactured at the group's formulations manufacturing facility at SEZ, Ahmedabad, it added.
Misoprostol is used to prevent stomach ulcers in patients taking pain medications especially if they are at risk for developing ulcers or have a past history of ulcers, Zydus Cadila said.
The group now has 268 approvals and has so far filed over 360 abbreviated new drug applications (ANDAs) since the commencement of its filing process, it added.
Zydus 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. It evolved over the next four decades into an established pharmaceutical company.
The company develops and manufactures a large range of pharmaceuticals as well as diagnostics, herbal products, skin care products and other OTC products.