Zydus Cadila receives USFDA’s final approval for mesalamine delayed–release tablets

DSIJ Intelligence / 25 Jul 2017

Zydus Cadila receives USFDA’s final approval for mesalamine delayed–release tablets

The group has received 27 final ANDA approvals from the USFDA and 2 tentative ANDA approvals since January 2017.

has received the Final approval has been received by Zydus Cadila from the USFDA for Mesalamine delayed-release tablets in the strength of 800 mg, the company said in a BSE filing on Tuesday.
 
The group’s formulation manufacturing facility at Moraiya will be manufacturing the drug. The group has received 27 final ANDA approvals from the USFDA and 2 tentative ANDA approvals since January 2017.
 
The group now has more than 130 approvals and has so far filed over 300 ANDAs since the commencement of the filing process in FY 2003-04, the company filing added.
 
At Rs 547.55, Cadila Healthcare was trading up by Rs 15.90 or 2.99% as of 1425 hours on Tuesday, on the BSE.

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