Medicine
Xalkori 50 mg capsule
Xalkori 50 mg capsule is a prescription medicine containing Crizotinib for oral use, marketed by Pfizer 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.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at room temperature 20° to 25°C (68° to 77°F), excursions permitted…
Key facts
- Active ingredient (INN)
- Crizotinib
- Brand
- Xalkori
- Strength
- 50 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 60 capsules
- Marketing authorisation holder
- Pfizer Laboratories
- Manufacturer
- Pfizer Laboratories
- Origin register
- US FDA, United States
- Storage
- Store at room temperature 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01ED01 Crizotinib
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 20 November 2023
- Identifiers
- RxCUI 1148498, 1148502, 1148504 +7DailyMed set ID 2a51b0de-47d6-455e-a94c-d2c737b04ff7NDC 0069-0507Application NDA217581
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 |
|---|---|---|---|
| 60 capsule, coated pellets in 1 bottle | 0069-0507-60 | Pfizer Laboratories | 20 November 2023 |
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 Crizotinib
Clinical summary
Crizotinib is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved test. MedsAcross supplies Crizotinib 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 CrizotinibFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Xalkori prescribing information (Pfizer Laboratories) · U.S. National Library of Medicine, DailyMed
- Xalkori: European public assessment report (EPAR) · European Medicines Agency
Need Xalkori 50 mg capsule 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.