Hot Pursuit     06-Apr-23
Zydus Life gets final USFDA nod for two drugs
The drug maker announced that it has received final approval from US Food and Drug Administration (USFDA) to manufacture and market Acetazolamide tablets and Carbidopa and Levodopa tablets.
Acetazolamide tablets is equivalent to reference listed drug, Diamox tablets, 125 mg and 250 mg.

Acetazolamide is used to treat glaucoma, a condition in which increased pressure in the eye can lead to gradual loss of vision. Acetazolamide decreases the pressure in the eye. Acetazolamide is also used to reduce the severity and duration of symptoms (upset stomach, headache, shortness of breath, dizziness, drowsiness, and fatigue) of altitude (mountain) sickness. The drug is used with other medicines to reduce edema (excess fluid retention) and to help control seizures in certain types of epilepsy.

The product will be manufactured at the group's formulation manufacturing facility in Baddi, Himachal Pradesh (India).

Acetazolamide tablets USP, 125 mg and 250 mg had annual sales of $16 million in the United States (IQVIA MAT December 2022).

Carbidopa and Levodopa Tablets is equivalent to reference listed drug, 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 $75 million in the United States (IQVIA MAT December 2022).

As on 31st December 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 is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.

The company's consolidated net profit jumped 24.5% to Rs 622.90 crore on 17.9% rise in net sales to Rs 4,159.80 crore in Q3 FY23 over Q3 FY22.

The scrip rose 0.32% to Rs 494.90 on the BSE.

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