Medicine
HYLENEX Recombinant 150 units/mL injection
HYLENEX Recombinant 150 units/mL injection is a prescription medicine containing Hyaluronidase (human recombinant) for subcutaneous use, marketed by Antares Pharma, 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 unopened in a refrigerator at 2°C to 8°C (36°F to 46°F). DO NOT FREEZE.
Key facts
- Active ingredient (INN)
- Hyaluronidase (human recombinant)
- Brand
- HYLENEX Recombinant
- Strength
- 150 units/mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 4 boxes
- Marketing authorisation holder
- Antares Pharma
- Manufacturer
- Antares Pharma
- Origin register
- US FDA, United States
- Storage
- Store unopened in a refrigerator at 2°C to 8°C (36°F to 46°F). DO NOT FREEZE.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 2 December 2005
- Identifiers
- RxCUI 630936, 630939DailyMed set ID 3023cc56-ed4b-4e87-b3a1-81b20943f658NDC 18657-117Application BLA021859
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 |
|---|---|---|---|
| 4 box in 1 carton / 1 vial in 1 box / 1 mL in 1 vial | 18657-117-04 | Antares Pharma | 2 December 2005 |
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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
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 Hyaluronidase (human recombinant) 150 units/mL injection.
Clinical summary
Hyaluronidase (human recombinant) is an endoglycosidase. It is available as injection for subcutaneous use. MedsAcross supplies Hyaluronidase (human recombinant) 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 Hyaluronidase (human recombinant)For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- HYLENEX Recombinant prescribing information (Antares Pharma) · U.S. National Library of Medicine, DailyMed
Need HYLENEX Recombinant 150 units/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.