Pure & Cure Healthcare gets CDSCO Panel nod to study Ferric Maltol Capsules 30 mg
Written By : Dr. Divya Colin
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-09-28 12:30 GMT | Update On 2024-09-28 12:30 GMT
Advertisement
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.
Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.