Zydus Cadila gets USFDA approval for two drugs

DSIJ Intelligence / 16 Aug 2017

Zydus Cadila gets USFDA approval for two drugs

The group now has more than 140 approvals and has so far filed over 300 ANDAs since the commencement of the filing process in FY03-04. 

Pharmaceutical major Zydus Cadila has received the USFDA’s final approval to market Tiadylt ER (Diltiazem Hydrochloride Extended-Release, USP) capsules (in strengths of 120 mg, 180 mg, 240 mg, 300 mg, 360 mg and 420 mg) and Azelastine Hydrochloride Nasal Spray (137 mcg). 
 
The group now has more than 140 approvals and has so far filed over 300 ANDAs since the commencement of the filing process in FY03-04. 
 
The Tiadylt ER capsules are used to treat hypertension, angina and certain heart rhythm disorders and it will be manufactured at the group’s formulations manufacturing facility at Ahmedabad. Azelastine Hydrochloride is used to relieve nasal symptoms such as runny/itching/stuffy nose, sneezing and post-nasal drip caused by allergies or other conditions. This will be manufactured at the Moraiya, Ahmedabad, facility.

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