Zydus receives final approval from the USFDA for two products, Gemfibrozil Tablets USP and Aripiprazole Orally Disintegrating Tablets USP

Shalini | Myequity news | Date : 30-08-2018 15:00:00 IST

Zydus Cadila has received the final approval from the USFDA to market Gemfibrozil Tablets USP 600 mg and Aripiprazole Orally Disintegrating Tablets USP in strengths of 10 mg, 15 mg, 20 mg, and 30 mg (US RLD - ABILIFY DISCMELT Orally Disintegrating Tablets).

Gemfibrozil Tablets are used together with diet to treat very high cholesterol and triglyceride levels in people with pancreatitis. Gemfibrozil is also used to lower the risk of stroke, heart attack or other heart complications in certain people with high cholesterol and triglycerides who have not benefitted from other treatment methods.

Aripiprazole is an atypical antipsychotic. The drug is used to treat certain mental/mood disorders, such as bipolar disorder, schizophrenia, Tourette's disorder, and irritability associated with autistic disorder. It may also be used in combination with other medication to treat depression.

Both the drugs will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad

In line with this, the group now has 215 approvals and has so far filed over 330 ANDAs since the commencement of the filing process in FY 2003-04.

About Zydus Cadila:

Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies. The group employs nearly 23,000 people worldwide and is dedicated to creating healthier communities globally. Zydus aspires to be a research-based pharmaceutical company by 2020.


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