The company has received final approval from the United States Food and Drug Administration to market Misoprostol tablets in the strengths of 100 mcg and 200 mcg.
Drug firm Zydus Cadila on July 3 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.
Shares of Cadila Healthcare, the listed entity of the group, were trading at Rs 236.75 per scrip on BSE, up 0.34 percent from its previous close.India Union Budget 2019: What does Finance Minister Nirmala Sitharaman have up her sleeve? Click here for top and latest Budget news, views and analyses.
