Zydus received 3 approvals from the USFDA within last week

Zydus received 3 approvals from the USFDA within last week

Zydus Cadila has received the final approval from the USFDA to market Atorvastatin Calcium Tablets in the strengths of 10 mg, 20 mg, 40 mg and 80 mg (US RLD – Lipitor). It will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad. Atorvastatin is used along with a proper diet to help lower “bad” cholesterol and fats (such as LDL, triglycerides) and raise “good” cholesterol (HDL) in the blood. It belongs to a group of drugs known as “statins.” It works by reducing the amount of cholesterol made by the liver. Lowering “bad” cholesterol and triglycerides and raising “good” cholesterol decreases the risk of heart disease and helps prevent strokes and heart attacks.

The group also received a tentative approval for Dimethyl Fumarate Delayed-Release Capsules, 120 mg and 240 mg (US RLD – TECFIDERA® capsules). It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. Dimethyl Fumarate is indicated for the treatment of patients with relapsing forms of multiple sclerosis. The group now has 233 approvals and has so far filed over 340 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Cadila has received the tentative approval from the USFDA to market Deferasirox Tablets, 90 mg, 180 mg, and 360 mg (US RLD – Exjade Tablets). It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. It is used to treat ongoing high levels of iron in the body caused by multiple blood transfusions. It is also used to treat high levels of iron in people with a certain blood disorder who do not require blood transfusions (non-transfusion-dependent thalassemia). The group now has 231 approvals and has so far filed over 340 ANDAs since the commencement of the filing process in FY 2003-04.

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