Medicine
Krystexxa 8 mg/50 mL injection
Krystexxa 8 mg/50 mL injection is a prescription medicine containing Pegloticase for intravenous use, marketed by Horizon Therapeutics, 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
Before the preparation for use, KRYSTEXXA must be stored in the carton and…
Key facts
- Active ingredient (INN)
- Pegloticase
- Brand
- Krystexxa
- Strength
- 8 mg/50 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 50 mL
- Marketing authorisation holder
- Horizon Therapeutics
- Manufacturer
- Horizon Therapeutics
- Origin register
- US FDA, United States
- Storage
- Before the preparation for use, KRYSTEXXA must be stored in the carton and maintained at all times under refrigeration between 2°C to 8°C (36°F to 46°F). Do not shake or freeze. Protect from light.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- M04AX02 Pegloticase
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 29 August 2025
- Identifiers
- DailyMed set ID 6e566303-d93a-4130-b764-25749829aa95NDC 75987-058Application BLA125293
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 in 1 carton / 50 mL in 1 vial | 75987-058-01 | Horizon Therapeutics | 29 August 2025 |
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 Pegloticase
Clinical summary
Pegloticase is a uric acid-specific enzyme indicated , for the treatment of chronic gout in adult patients refractory to conventional therapy. It is available as injection for intravenous use. MedsAcross supplies Pegloticase 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 PegloticaseFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Krystexxa prescribing information (Horizon Therapeutics) · U.S. National Library of Medicine, DailyMed
Need Krystexxa 8 mg/50 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.