Alembic Pharma secures USFDA final nod for Parkinson’s therapy tablets

Alembic Pharmaceuticals Limited on Friday, February 6, said it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Carbidopa, Levodopa and Entacapone tablets, strengthening its presence in the US generics market.

In a regulatory filing, the company said the approval covers multiple strengths of the combination therapy, including 12.5 mg/50 mg/200 mg, 18.75 mg/75 mg/200 mg, 25 mg/100 mg/200 mg, 31.25 mg/125 mg/200 mg, 37.5 mg/150 mg/200 mg and 50 mg/200 mg/200 mg. The product is therapeutically equivalent to Stalevo tablets of Orion Corporation, the reference listed drug.

Carbidopa, levodopa and entacapone tablets are indicated for the treatment of Parkinson’s disease, the company said, adding that usage is subject to the approved label.

With this approval, Alembic’s cumulative ANDA approvals from the USFDA now stand at 234, comprising 214 final approvals and 20 tentative approvals.

For the December quarter, the company reported a 10.8% year-on-year rise in revenue to ₹1,876.3 crore. EBITDA grew 12.8% to ₹293.5 crore, while margins improved marginally to 15.6% from 15.4% a year ago. Net profit declined 4.1% YoY to ₹132 crore, impacted by a one-time expense of ₹42 crore linked to employee benefits following changes under the new labour code.

Shares of Alembic Pharma were trading 2.45% down at ₹790.60 as of 12.08 pm on Friday. The stock has declined 16.63% in the past six months.

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