Zydus gets USFDA approval for Carbidopa and Levodopa Tablets USP, 10 mg/100 mg, 25 mg/100 mg, and 25 mg/250 mg

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Carbidopa and Levodopa Tablets USP, 10 mg/100 mg, 25 mg/100 mg, and 25 mg/250 mg (USRLD: Sinemet Tablets, 10 mg/100 mg, 25 mg/100 mg, and 25 mg/250 mg).

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’s 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 $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.