Last Updated on December 31, 2023 by The Health Master
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.
These Indian Pharma Cos seek nod from DCGI for marketing Anti Covid drug Molnupiravir
DCGI nod for device-aided therapy for Parkinson’s patients
Drug to treat Dengue developed, DCGI nod for trial
Biological E seeks DCGI nod for phase-3 trial for Booster dose
Molbio gets DCGI nod for Truenat Scrub T test for Scrub Typhus
Govt notifies new protocol for post-mortem procedure
Govt to implement PTUA scheme soon for Pharma MSMEs
Sun Pharma to introduce Molnupiravir in India
PCI issues further advisory to Pharmacy Colleges regarding salaries to Teachers
A woman doing illegal MTPs arrested: Haryana
International Conference on National Education Policy will be held at …
IPC adds new impurities and Reference Standards: Download the list
Drug alert: 36 out of 1061 samples declared as NSQ in October 2021
Latest Circulars by the Govt of India, Dept of Pharmaceuticals, Health…
Latest Notifications regarding Pharmaceuticals
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
