Cadila gets CDSCO panel nod to manufacture, market Calcium Polystyrene Sulphonate suspension
New Delhi: Pharmaceutical major Cadila Healthcare has got a green signal from the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) for the manufacturing and marketing of Calcium Polystyrene Sulphonate suspension 15g/60ml indicated for the treatment of hyperkalemia associated with oliguria, anuria, or dialysis.
This came after the firm presented data/justification before the committee for approval of Calcium Polystyrene Sulphonate suspension 15g/60ml in accordance with the earlier SEC recommendation.
Polystyrene sulfonates are polymers derived from polystyrene by the addition of sulfonate functional groups. They are widely used as ion-exchange resins to remove ions such as potassium, calcium, and sodium from solutions in technical or medical applications. Additionally, they can be used to remove toxins.
Increased potassium levels in the blood are treated with calcium polystyrene sulphonate. It's given to those who have renal difficulties or are on dialysis.
Calcium polystyrene sulphonate is marketed by Zydus Cadila under the brand name K-Bind Powder. Other brands include Panacea Biotec's K Bait, Micro Lab's Seebind, Intas Pharmaceuticals' Renx and others.
Earlier, at the 88th SEC meeting for Cardiovascular and Renal dated 15.07.2021, the drug-maker Cadila Healthcare presented their proposal for the manufacturing and marketing of Calcium Polystyrene Sulphonate suspension 15g/60ml.
Responding to this, the committee opined that the firm should submit the stability data and compare it with the Calcium Polystyrene Sulphonate sachet formulation currently available on the market for further consideration by the committee.
In continuation, at the 92nd SEC meeting for Cardiovascular and Renal held on 10.11.2021 and 11.11.2021 at CDSCO, the drug-maker presented data/justification before the committee for approval of Calcium Polystyrene Sulphonate suspension 15g/60ml.
After detailed deliberation, the committee recommended the grant of permission for the manufacturing and marketing of Calcium Polystyrene Sulphonate suspension 15g/60ml, indicated for the treatment of hyperkalemia associated with oliguria, anuria, or dialysis.
