ChemLifeIntel
CHEMICAL & LIFE SCIENCES INTELLIGENCE
Access

Apipharma

HIGH RISKHQ: — · Private · Founded —
LISTINGPrivateFOUNDED0
FOCUS THERAPY AREAS
Manufacturer
COMPANY INTELLIGENCE SNAPSHOTlive
0
Manufacturing Sites
1
Intelligence Briefs
0
Active Regulatory Actions
HQ Country
NO ACTIVE REGULATORY ACTIONSClean compliance footprint across 0 monitored sites · HQ
View regulatory detail

INTELLIGENCE

Showing 1 of 1 briefs on Apipharma
REGULATORY INTELLIGENCE·Recall

FDA Initiates Class II Recall of Apipharma's Hemopropin Ointment Over CGMP Deviations from Croatian Facility

Apipharma faces an FDA Class II recall for 4,218 boxes of Hemopropin Ointment, citing Current Good Manufacturing Practice (CGMP) deviations at its Zagreb, Croatia facility. This action, initiated by the firm, highlights critical quality control failures, posing significant supply chain and regulatory compliance challenges for global procurement and regulatory affairs teams sourcing similar topical formulations.

90-Day Activity
ApipharmaHemopropin Ointment
CMCatherine Morrow· Senior Regulatory Intelligence Analyst
2025-04-30