Fresenius Told To Submit Approval Basis, Phase III Data for Calcium Chloride Dihydrate Infusion Proposal
New Delhi: In response to the proposal presented by Fresenius Medical Care, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended the firm to submit basis of approval along with Phase-III clinical trial data of the Calcium chloride dihydrate and Post marketing surveillance data in approved countries for further deliberation.
This came after the firm presented their proposal for grant of permission to manufacture and marketing of Calcium chloride dihydrate 100 mmol/l Solution for infusion for ‘calcium substitution in continuous renal replacement therapies (CRRT), sustained low efficiency (daily) dialysis (SLEDD) and therapeutic plasma exchange (TPE) using citrate for anticoagulation. Product is indicated in adults and children’ along with justification for Phase-III and Phase IV Clinical trial waiver.
The committee noted that the applied product is approved in Portugal, United Kingdom, Brazil, Switzerland, France, Denmark and other European countries.
Calcium chloride dihydrate is the chemical compound CaCl2·2H2O, a form of calcium chloride containing two water molecules per unit of calcium chloride. It is a white crystalline solid, readily soluble in water, and hygroscopic, meaning it absorbs moisture from the air.
Calcium Chloride Dihydrate is a compound that, when dissolved in methanol, is used as a solvent system for the dissolution of chitin. It plays a crucial role in breaking down the crystalline structure of chitin for various applications in chemistry.
At the recent SEC meeting for Renal held on 20th May 2025, the expert panel reviewed the proposal for grant of permission to manufacture and marketing of Calcium chloride dihydrate 100 mmol/l Solution for infusion for ‘calcium substitution in continuous renal replacement therapies (CRRT), sustained low efficiency (daily) dialysis (SLEDD) and therapeutic plasma exchange (TPE) using citrate for anticoagulation. Product is indicated in adults and children’ along with justification for Phase-III and Phase IV Clinical trial waiver.
After detailed deliberation, the committee recommended to submit basis of approval along with Phase-III clinical trial data and Post marketing surveillance data in approved countries for further deliberation by the committee.
Also Read: CDSCO Panel Clears Sanofi's Updated Myozyme Insert, Seeks Revision on Administration Guidance
