Medicine
Infasurf 35.7 mg/mL inhalation suspension
Infasurf 35.7 mg/mL inhalation suspension is a prescription medicine containing Calfactant for endotracheal use, marketed by ONY Biotech, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
INFASURF (calfactant) intratracheal suspension is an off-white suspension…
Key facts
- Active ingredient (INN)
- Calfactant
- Brand
- Infasurf
- Strength
- 35.7 mg/mL
- Dosage form
- Inhalation suspension
- Route
- Endotracheal
- Packs
- 1 vial
- Marketing authorisation holder
- ONY Biotech
- Manufacturer
- ONY Biotech
- Origin register
- US FDA, United States
- Storage
- INFASURF (calfactant) intratracheal suspension is an off-white suspension available in a sterile, rubber-stoppered glass single-dose vial packaged as one vial per carton: 105 mg/3 mL (35 mg/mL) (NDC 61938-456-03) 210 mg/6 mL (35 mg/mL) (NDC 61938-456-06) Refrigerate INFASURF (calfactant) intratracheal suspension at 2°C to 8°C (36°F to 46°F) and protect from light.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 18 October 1999
- Identifiers
- DailyMed set ID 315c128a-272d-4c57-bfbe-1a8b3402af08NDC 61938-456Application BLA020521
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 vial, glass in 1 carton / 3 mL in 1 vial, glass | 61938-456-03 | ONY Biotech | 12 December 2002 |
| 1 vial, glass in 1 carton / 6 mL in 1 vial, glass | 61938-456-06 | ONY Biotech | 18 October 1999 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 1 July 1998 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Clinical summary
Calfactant is a surfactant. It is available as inhalation suspension for endotracheal use. MedsAcross supplies Calfactant for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about CalfactantFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- INFASURF prescribing information (ONY Biotech) · U.S. National Library of Medicine, DailyMed
Need Infasurf 35.7 mg/mL inhalation suspension for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.