Medicine
Omlyclo 300 mg/2 mL injection
Omlyclo 300 mg/2 mL injection is a prescription medicine containing Omalizumab for subcutaneous use, marketed by Celltrion, 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
OMLYCLO prefilled syringe should be shipped and stored under refrigerated…
Key facts
- Active ingredient (INN)
- Omalizumab
- Brand
- Omlyclo
- Strength
- 300 mg/2 mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 1 syringe of 2 mL, 2 syringes of 2 mL
- Marketing authorisation holder
- Celltrion
- Manufacturer
- Celltrion
- Origin register
- US FDA, United States
- Storage
- OMLYCLO prefilled syringe should be shipped and stored under refrigerated conditions 36°F to 46°F (2°C to 8°C) in the original carton. The total combined time out of the refrigerator may not be more than 7 days. Do not freeze. Do not use if prefilled syringe is left at temperatures above 77°F (25°C ). OMLYCLO prefilled syringe can be removed from and placed back in the refrigerator if needed.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- R03DX05 Omalizumab
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 5 October 2026
- Identifiers
- RxCUI 2726001, 2726008, 2726010 +3DailyMed set ID dbd8709f-1636-45d9-ba94-5a3bc5f22f84NDC 72606-054Application BLA761399
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
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.
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
Alternatives
Other makers and brands of Omalizumab 300 mg/2 mL injection.
Other strengths and forms of Omalizumab
Clinical summary
Omalizumab is an anti-IgE indicated for moderate to severe persistent asthma in adults, among other approved uses. It is available as injection for subcutaneous use. MedsAcross supplies Omalizumab 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 OmalizumabFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- XOLAIR prescribing information (Genentech) · U.S. National Library of Medicine, DailyMed
- Xolair: European public assessment report (EPAR) · European Medicines Agency
- Omlyclo: European public assessment report (EPAR) · European Medicines Agency
Need Omlyclo 300 mg/2 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.