Medicine
Xiaflex kit
Xiaflex kit is a prescription medicine containing Collagenase clostridium histolyticum, marketed by Endo, 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
Do not freeze. and Stability Prior to reconstitution, the vials of XIAFLEX and…
Key facts
- Active ingredient (INN)
- Collagenase clostridium histolyticum
- Brand
- Xiaflex
- Dosage form
- Kit
- Packs
- 1 kit, 2 cartons
- Marketing authorisation holder
- Endo
- Manufacturer
- Endo
- Origin register
- US FDA, United States
- Storage
- Do not freeze. and Stability Prior to reconstitution, the vials of XIAFLEX and diluent should be stored in a refrigerator at 2°C to 8°C (36°F to 46°F). The reconstituted XIAFLEX solution can be kept at room temperature (20°C to 25°C/68°F to 77°F) for up to 1 hour or refrigerated at 2°C to 8°C (36°F to 46°F) for up to 4 hours prior to administration.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- D03BA02 Collagenase clostridium histolyticum
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 22 February 2010
- Identifiers
- RxCUI 898495, 898499DailyMed set ID 805cecd0-fd1f-11dd-87af-0800200c9a66NDC 66887-003Application BLA125338
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 kit in 1 carton * 1 injection, powder, lyophilized, for solution in 1 vial * 3 mL in 1 vial | 66887-003-01 | Endo | 22 February 2010 |
| 2 carton in 1 carton / 1 kit in 1 carton * 1 injection, powder, lyophilized, for solution in 1 vial * 3 mL in 1 vial | 66887-003-02 | Endo | 22 February 2010 |
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 Collagenase clostridium histolyticum
Clinical summary
Collagenase clostridium histolyticum is a collagen-specific enzyme indicated for the treatment of adult patients with Dupuytren’s contracture with a palpable cord, among other approved uses. It is available as kits and ointment for topical use. MedsAcross supplies Collagenase clostridium histolyticum 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 Collagenase clostridium histolyticumFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- XIAFLEX prescribing information (Endo) · U.S. National Library of Medicine, DailyMed
Need Xiaflex kit 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.