Medicine
Glycerol phenylbutyrate 1.1 g/mL oral liquid
Glycerol phenylbutyrate 1.1 g/mL oral liquid is a generic prescription medicine for oral use, made by 9 labelers, 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 20º to 25ºC (68º to 77ºF), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Glycerol phenylbutyrate
- Brand
- Sold under the generic name
- Strength
- 1.1 g/mL
- Dosage form
- Oral liquid
- Route
- Oral
- Packs
- 1 bottle, 4 bottles and 8 more
- Manufacturers
- Camber PharmaceuticalsIndiaNovadoz PharmaceuticalsIndiaAurobindo PharmaIndiaLupinIndiaZydus LifesciencesIndiaNavintaPAI PharmaPar HealthTeva Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20º to 25ºC (68º to 77ºF), excursions permitted to 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
- A16AX09 Glycerol phenylbutyrate
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 17 October 2025
- Identifiers
- RxCUI 1368453DailyMed set ID 15c4da9f-f5e0-4628-b55f-3730be3e1c39, e78f2dfd-fb39-4e4b-a639-64591d282ca6, 11981aec-dbf1-4906-acfd-3c10708fe0a6 +6NDC 68475-807, 49884-264, 59651-988 +6Application ANDA220568, ANDA205742, ANDA220313 +4
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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle, glass in 1 carton / 25 mL in 1 bottle, glass | 59651-988-25 | Aurobindo PharmaIndia | 15 April 2026 |
| 1 bottle in 1 carton / 25 mL in 1 bottle | 31722-605-31 | Camber PharmaceuticalsIndia | 21 August 2026 |
| 4 bottle in 1 carton / 25 mL in 1 bottle | 31722-605-32 | Camber PharmaceuticalsIndia | 21 August 2026 |
| 1 bottle in 1 carton / 25 mL in 1 bottle | 70748-425-01 | LupinIndia | 20 October 2025 |
| 1 bottle in 1 carton / 25 mL in 1 bottle | 72205-331-57 | Novadoz PharmaceuticalsIndia | 16 April 2026 |
| 4 bottle in 1 carton / 25 mL in 1 bottle | 72205-331-58 | Novadoz PharmaceuticalsIndia | 16 April 2026 |
| 1 bottle in 1 carton / 25 mL in 1 bottle | 70710-2193-5 | Zydus LifesciencesIndia | 4 May 2026 |
| 1 bottle in 1 carton / 25 mL in 1 bottle | 68475-807-01 | Navinta | 11 July 2026 |
| 1 bottle in 1 carton / 25 mL in 1 bottle | 0121-1049-25 | PAI Pharma | 12 October 2026 |
| 1 bottle in 1 carton / 25 mL in 1 bottle | 49884-264-95 | Par Health | 17 October 2025 |
| 1 bottle in 1 carton / 25 mL in 1 bottle | 0480-3777-58 | Teva Pharmaceuticals | 16 April 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.
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 Glycerol phenylbutyrate 1.1 g/mL oral liquid.
Clinical summary
Glycerol phenylbutyrate is a nitrogen binding agent indicated as a nitrogen-binding agent for chronic management of patients with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. MedsAcross supplies Glycerol phenylbutyrate 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 Glycerol phenylbutyrateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Ravicti prescribing information (Horizon Therapeutics) · U.S. National Library of Medicine, DailyMed
- Ravicti: European public assessment report (EPAR) · European Medicines Agency
Need Glycerol phenylbutyrate 1.1 g/mL oral liquid 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.