Conduct bioequivalence study: CDSCO Panel Tells Emcure Pharmaceutical on Ferric Maltol Capsules
Written By : Dr. Divya Colin
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-03-23 12:30 GMT | Update On 2024-03-23 12:30 GMT
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New Delhi: Citing there is an unmet medical need, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined Emcure Pharmaceutical to conduct the bioequivalence study (BE) of the Ferric Maltol Capsules 30mg, a complexed iron supplement used to treat iron deficiency in adults.
This came after Emcure Pharmaceutical presented its proposal for a grant of permission to manufacture and market the drug along with BE study protocol vide no. VRL-24-001, Version no. 2.0, dated 09.01.2024, along with a request for Phase III Clinical trial waiver before the committee.
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