Zydus receives final approval from the USFDA for Carbidopa and Levodopa Tablets

Zydus receives final approval from the USFDA for Carbidopa and Levodopa Tablets

By: IPP Bureau

Last updated : April 07, 2023 10:15 am



Carbidopa and Levodopa is used to treat symptoms of Parkinson's disease or Parkinson-like symptoms


Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Carbidopa and Levodopa Tablets USP.

Carbidopa and Levodopa is used to treat symptoms of Parkinson's disease or Parkinson-like symptoms (such as shakiness, stiffness, difficulty moving). This medicine is also used to treat Parkinson symptoms caused by carbon monoxide, carbon monoxide poisoning or manganese intoxication. The product will be manufactured at the group’s formulation manufacturing facility in SEZ Ahmedabad, (India).

Carbidopa and Levodopa Tablets USP, 10 mg/100 mg, 25 mg/100 mg, and 25 mg/250 mg had annual sales of US $75 million in the United States (IQVIA MAT Dec. 2022).

The group now has 359 approvals and has so far filed over 440 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences Limited USFDA

First Published : April 07, 2023 12:00 am