Is Calfactant registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Calfactant, including INFASURF 35 MG/ML INTRATRACHEAL SUSPENSION (35 mg/ml, Suspension, SAR 892.25).

Is Calfactant approved by the US FDA?

Drugs@FDA lists 1 application product line for Calfactant, including INFASURF PRESERVATIVE FREE (Prescription).

Active substance

Calfactant

SFDA 2
US FDA 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
INFASURF 35 MG/ML INTRATRACHEAL SUSPENSION	35 mg/ml	Suspension · Intratracheal use	1 Vial	SAR 892.25	NCE · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
INFASURF 35 MG/ML INTRATRACHEAL SUSPENSION	35 mg/ml	Suspension · Intratracheal use	1 Vial	SAR 1726.20	NCE · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid

Indications — CHI Daman Drug Formulary

NEONATAL RESPIRATORY DISTRESS SYNDROME (NRDS)

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
INFASURF PRESERVATIVE FREE	35MG/ML	suspension · intratracheal	ONY	Prescription	1 Jul 1998

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.