top of page
Writer's pictureSanjay Trivedi

Zydus receives final approval from USFDA for Nifedipine Extended-Release Tablets USP & Cholestyr


Zydus Cadila has received the final approval from the USFDA to market Nifedipine Extended-Release Tablets USP (Adalat® CC) in the strengths of 30 mg, 60 mg, and 90 mg. It is used to treat high blood pressure and angina (chest pain brought on by exercise or stress). It works to control blood pressure and reduce the number of angina attacks by relaxing blood vessels. It will be manufactured at the group’s manufacturing facility at Moraiya, Ahmedabad. The group also received the final approval to market Cholestyramine for Oral Suspension USP (Questran®), 4 g resin per pouch or scoopful. It is used alongwith a proper diet to lower cholesterol in the blood. Lowering cholesterol helps decrease the risk for strokes and heart attacks. It will be manufactured at the group’s formulations manufacturing facility at Baddi. In line with this, the group now has 201 approvals and has so far filed over 330 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus receives tentative approval from the USFDA for Deferasirox Tablets for Oral Suspension

Zydus Cadila has received the tentative approval from the USFDA to market Deferasirox Tablets for Oral Suspension (Exjade Tablets) in the strengths of 125 mg, 250 mg and 500 mg. 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). It will be manufactured at the group’s manufacturing facility at SEZ, Ahmedabad. The estimated sale for Deferasirox Tablets is $ 150.3 million (Source: IMS Health, IMS National Sales Perspective Audit, MAT May 2018, extracted June 2018.) In line with this, the group now has 202 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 over 22,000 people worldwide and is dedicated to creating healthier communities globally. Zydus aspires to be a research-based pharmaceutical company by 2020.

3 views0 comments

Recent Posts

See All
bottom of page