Medicine
Cytalux 3.2 mg/1.6 mL injection
Cytalux 3.2 mg/1.6 mL injection is a prescription medicine containing Pafolacianine for intravenous use, marketed by On Target Laboratories, 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
Storage Condition Condition Temperature Range Maximum Single Period…
Key facts
- Active ingredient (INN)
- Pafolacianine
- Brand
- Cytalux
- Strength
- 3.2 mg/1.6 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 10 cartons of 1.6 mL
- Marketing authorisation holder
- On Target Laboratories
- Manufacturer
- On Target Laboratories
- Origin register
- US FDA, United States
- Storage
- Storage Condition Condition Temperature Range Maximum Single Period Permissible Freeze-Thaw Cycles Frozen -25°C to -15°C (-13°F to 5°F) Until Expiration Date Not applicable Refrigeration 2°C to 8°C (36°F to 46°F) Up to 30 days Three Room Temperature 20°C to 25°C (68°F to 77°F) Up to 24 hours Three Do not use the product past the expiration date Store vials in their original cartons to protect…
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 29 November 2021
- Identifiers
- DailyMed set ID d21952b9-7c4e-3a56-e053-2a95a90a0ab0NDC 81052-138Application NDA214907
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 |
|---|---|---|---|
| 10 carton in 1 carton / 1 vial, single-dose in 1 carton / 1.6 mL in 1 vial, single-dose | 81052-138-10 | On Target Laboratories | 29 November 2021 |
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 29 November 2021 | 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
Pafolacianine is an optical imaging agent indicated as an adjunct for intraoperative identification of malignant lesions in adult patients with ovarian cancer. It is available as injection for intravenous use. MedsAcross supplies Pafolacianine 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 PafolacianineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Cytalux prescribing information (On Target Laboratories) · U.S. National Library of Medicine, DailyMed
Need Cytalux 3.2 mg/1.6 mL injection 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.