Alembic Pharma Gets CDSCO Panel Nod to Study FDC Carbidopa, Levodopa ER Capsule for export purpose only

This came after Alembic Pharmaceutical presented a proposal along with the BE Study protocol for export purposes only.

The combination of Carbidopa and Levodopa treats the symptoms of Parkinson's disease. It works by increasing the amount of dopamine in the brain, a substance that helps manage body movements and coordination. This reduces the symptoms of Parkinson's, such as body stiffness and tremors.

Carbidopa and levodopa are a medication that decreases the amount of dopamine in the brain that manages movement and coordination. It treats the symptoms of Parkinson's disease, like stiffness and tremors.

Carbidopa is a dopa decarboxylase inhibitor used in combination with levodopa for the symptomatic treatment of idiopathic Parkinson disease and other conditions associated with parkinsonian symptoms. Carbidopa presents a chemical denomination of N-amino-alpha-methyl-3-hydroxy-L-tyrosine monohydrate. It potently inhibits aromatic amino acid decarboxylase (DDC) and due to its chemical properties, it does not cross the blood-brain barrier. Due to its activity, carbidopa is always administered concomitantly with levodopa.

Levodopa crosses the blood-brain barrier where it is converted to dopamine by decarboxylation in the presynaptic terminals of dopaminergic neurons. After release, it is transported back into the dopaminergic terminals or is metabolized either by catechol-O-methyltransferase (COMT) or by monoamine oxidase (MAO).

At the recent SEC meeting for Neurology and Psychiatry held on 12th and 13th December 2023, the expert panel reviewed the proposal presented by the drug major Alembic Pharmaceutical along with the BE study protocol for export purposes.

After deliberation, the committee recommended for BA/BE study for export purposes only.

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