Medicine
Xenleta 600 mg tablet
Xenleta 600 mg tablet is a prescription medicine containing Lefamulin for oral use, marketed by Meitheal Pharmaceuticals, 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
Store in a refrigerator. Do not freeze. The diluent bags should be stored in…
Key facts
- Active ingredient (INN)
- Lefamulin
- Brand
- Xenleta
- Strength
- 600 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 10 tablets
- Marketing authorisation holder
- Meitheal Pharmaceuticals
- Manufacturer
- Meitheal Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store in a refrigerator. Do not freeze. The diluent bags should be stored in barrier overwrap at 2°C to 25°C (36°F to 77°F) until ready to use.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- J01XX Antibiotics for systemic use, subgroup J01X, subgroup J01XX
- HS code (indicative)
- 3004.20Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 9 September 2019
- Identifiers
- RxCUI 2198948, 2198953, 2198961 +3DailyMed set ID eb972ea8-7502-422e-84bb-66cb8e93ca06NDC 71288-037Application NDA211672
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 tablet, coated in 1 blister pack | 71288-037-10 | Meitheal Pharmaceuticals | 9 September 2019 |
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
Other strengths and forms of Lefamulin
Clinical summary
Lefamulin is a pleuromutilin antibacterial indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by susceptible microorganisms, among other approved uses. It is available as injection and tablets for intravenous and oral use. MedsAcross supplies Lefamulin 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 LefamulinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Xenleta prescribing information (Meitheal Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Xenleta: European public assessment report (EPAR) · European Medicines Agency
Need Xenleta 600 mg tablet 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.