Medicine
Genglycos kit
Genglycos kit is a prescription medicine containing Pariglasgene brecaparvovec, marketed by Ultragenyx Pharmaceutical, 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
If necessary, an intact vial (stopper not yet punctured) that has been thawed…
Key facts
- Active ingredient (INN)
- Pariglasgene brecaparvovec
- Brand
- Genglycos
- Dosage form
- Kit
- Packs
- 1 kit and 10 more
- Marketing authorisation holder
- Ultragenyx Pharmaceutical
- Manufacturer
- Ultragenyx Pharmaceutical
- Origin register
- US FDA, United States
- Storage
- If necessary, an intact vial (stopper not yet punctured) that has been thawed can be stored refrigerated 2°C-8°C (36°F - 46°F) for up to 12 days, upright and protected from light (e.g., in the original carton). Store upright at ≤ -60ºC (-76ºF). Store in the original carton until ready to use.
- 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
- 17 September 2026
- Identifiers
- RxCUI 2753322, 2753329, 2753331 +7DailyMed set ID ef9144f5-10c3-47d9-a7c6-ab5ff11e9bf8NDC 69794-339, 69794-333, 69794-337 +10Application BLA125858
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 * 2 mL in 1 vial | 69794-333-03 | Ultragenyx Pharmaceutical | 17 September 2026 |
| 1 kit in 1 carton * 2 mL in 1 vial | 69794-334-03 | Ultragenyx Pharmaceutical | 17 September 2026 |
| 1 kit in 1 carton * 2 mL in 1 vial | 69794-335-03 | Ultragenyx Pharmaceutical | 17 September 2026 |
| 1 kit in 1 carton * 2 mL in 1 vial | 69794-336-03 | Ultragenyx Pharmaceutical | 17 September 2026 |
| 1 kit in 1 carton * 2 mL in 1 vial | 69794-337-03 | Ultragenyx Pharmaceutical | 17 September 2026 |
| 1 kit in 1 carton * 2 mL in 1 vial | 69794-338-03 | Ultragenyx Pharmaceutical | 17 September 2026 |
| 1 kit in 1 carton * 2 mL in 1 vial | 69794-339-03 | Ultragenyx Pharmaceutical | 17 September 2026 |
| 1 kit in 1 carton * 2 mL in 1 vial | 69794-340-03 | Ultragenyx Pharmaceutical | 17 September 2026 |
| 1 kit in 1 carton * 2 mL in 1 vial | 69794-341-03 | Ultragenyx Pharmaceutical | 17 September 2026 |
| 1 kit in 1 carton * 2 mL in 1 vial | 69794-342-03 | Ultragenyx Pharmaceutical | 17 September 2026 |
| 1 kit in 1 carton * 2 mL in 1 vial | 69794-343-03 | Ultragenyx Pharmaceutical | 17 September 2026 |
| 1 kit in 1 carton * 2 mL in 1 vial | 69794-344-03 | Ultragenyx Pharmaceutical | 17 September 2026 |
| 1 kit in 1 carton * 2 mL in 1 vial | 69794-345-03 | Ultragenyx Pharmaceutical | 17 September 2026 |
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
Clinical summary
Pariglasgene brecaparvovec is a prescription medicine indicated to reduce daily cornstarch intake as an adjunct to nutritional management in adult and pediatric patients 8 years of age and older with glycogen storage disease type Ia (GSDIa). MedsAcross supplies Pariglasgene brecaparvovec 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 Pariglasgene brecaparvovecFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- GENGLYCOS prescribing information (Ultragenyx Pharmaceutical) · U.S. National Library of Medicine, DailyMed
Need Genglycos 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.