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GeminiBio Submits Drug Master File (DMF) to FDA

News

Mar 13, 2025

GeminiBio Submits Drug Master File (DMF) for its cGMP-grade GemCell™ Human AB Serum to FDA - Simplifying IND and BLA filings for cell therapy developers

coaC424007 – BSA 30% – 700-110

coa

Mar 11, 2025

coaC423009 -GemCell Newborn Calf Serum – 100-504

coa

Mar 11, 2025

coaA424043 – AbSolute Low IgG FBS – 100-120

coa

Mar 11, 2025

coaA324001 – BenchMark FBS – 100-106

coa

Mar 11, 2025

coaC122014 – BSA Fraction-V Cohn – 700-108P

coa

Mar 11, 2025

coaA121039 – Stasis Stem Cell Qualified FBS – 100-525

coa

Mar 11, 2025

coaM123058 – GemPure WFI Quality Water (USP Grade) – 901-001-103

coa

Mar 11, 2025

coaH423032 – GemCell Plus HSAB Xeno-Free – 100-912

coa

Mar 11, 2025

coaH423032 – GemCell Plus HSAB Xeno-Free – 100-912

coa

Mar 11, 2025

coaG424162 -BDNF – 300-104P

coa

Mar 11, 2025

coaG424124 – TPO – 300-351P

coa

Mar 11, 2025

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