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Zydus receives approval from the USFDA for Temozolomide Capsules and Nadolol Tablets USP

 

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Clinical courses

Zydus Cadila has received the final approval from the USFDA to market Temozolomide Capsules in strengths of 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, and 250 mg.

Temozolomide capsules is a chemotherapy drug used in the management of brain tumors. The sale of Temozolomide is estimated at $100.4 Mil. Source: IMS Health, IMS National Sales Perspective Audit, MAT June 2017, extracted August 2017.

The group also received the final approval from the USFDA to market Nadolol Tablets USP, 20 mg, 40 mg, and 80 mg. Nadolol is used in management of hypertension (high blood pressure) and angina pectoris (chest pain). The sales of Nadolol tablets is estimated at $109.8 mil. Source: IMS Health, IMS National Sales Perspective Audit, MAT June 2017, extracted August 2017.

 

Both the drugs will be manufactured at the group’s formulations manufacturing facility at he Pharma SEZ, Ahmedabad.

The group now has more than 130 approvals and has so far filed over 300 ANDAs since the commencement of the filing process in FY 2003-04.

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