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Writer's pictureSanjay Trivedi

Zydus receives final approval from the USFDA for Methylprednisolone Tablets USP and Cinacalcet Hydro


Zydus Cadila has received the final approval from the USFDA to market Methylprednisolone Tablets USP in the strengths of 4 mg, 8 mg, 16 mg and 32 mg. It is used to treat conditions such as arthritis, blood disorders, severe allergic reactions, certain cancers, eye conditions, skin/kidney/intestinal/lung diseases and immune system disorders. It will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad.

The group also received the final approval to market Cinacalcet Hydrochloride Tablets in the strengths of 30 mg (Eq. base), 60 mg (Eq. base) and 90 mg (Eq. base). It is indicated for the treatment of high blood calcium in patients with cancer of parathyroid glands and for the treatment of high blood parathyroid hormone levels seen in patients with chronic kidney disease on dialysis. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. The group now has more than 185 approvals and has so far filed over 320 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 21,000 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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