New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted permission to Pure and Cure Healthcare to conduct the bio-equivalence study of Ferric Maltol Capsules 30 mg as per the protocol presented.
This came after the firm presented the proposal for grant of permission to manufacture and market of Ferric Maltol Capsules 30 mg along with bioequivalence study protocol (No. VRL-23-004, Ver-1.0, dated: 01.09.2023 and Phase III clinical trial waiver justification before the committee.
Ferric maltol is a complex iron supplement used to treat iron deficiency in adults. Ferric maltol dissociates as the iron atom is donated to unknown iron uptake mechanisms, possibly beta 3 integrin or divalent metal transporter 1, in the ileum and duodenum. Once the iron is in circulation, it is associated with transferrin and ferritin.
At the recent SEC meeting for Hematology held on September 10, 2024, the expert panel reviewed the proposal for the grant of permission to manufacture and market Ferric Maltol Capsules 30 mg along with the bioequivalence study protocol (No. VRL-23-004, Ver-1.0, dated: 01.09.2023, and Phase III clinical trial waiver justification before the committee.
After detailed deliberation, the committee recommended the grant of permission to conduct a bio-equivalence study as per the protocol presented.
Furthermore, the expert panel suggested that the result of the bio-equivalence study should be presented before the committee for further consideration.
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