Zydus receives final approval from the USFDA for Carbidopa and Levodopa Tablets USP, 10 mg/100 mg, 25 mg/100 mg, and 25 mg/250 mg

Zydus receives final approval from the USFDA for Carbidopa and Levodopa Tablets USP, 10 mg/100 mg, 25 mg/100 mg, and 25 mg/250 mg Ahmedabad, India, 6 April, 2023 Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) 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 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 USD 75 mn 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. (*as of 31st December 2022) ***

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