US Food and Drug Administration (FDA) has given its nod to Indian pharmaceutical major Zydus Cadila for manufacturing of ‘Mesalamine Delayed-Release Tablets’ in the strength of 800 mg, which is used to cure patients with active, mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis.
“The drug will be manufactured at the group’s manufacturing facility at Moraiya in Ahmadabad district in Gujarat,” the company said.
In this year, the company –involved in the development and manufacturing healthcare therapies –received 27 Abbreviated New Drug Application (ANDA) approvals along with two tentative approvals from the FDA.
It has more than 130 approvals, so far, and has filed over 300 Abbreviated New Drug Applications since FY 2003-04.
The company will produce the colitis tablets for the US market at its manufacturing facility at Moraiya in Sanand, Ahmedabad, Gujarat.