Medicine
Carglumic acid 200 mg tablet for oral suspension
Carglumic acid 200 mg tablet for oral suspension is a generic prescription medicine for oral use, made by 3 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
Do not refrigerate. Store at 20° to 25°C (68°F to 77°F), excursions permitted…
Key facts
- Active ingredient (INN)
- Carglumic acid
- Brand
- Sold under the generic name
- Strength
- 200 mg
- Dosage form
- Tablet for oral suspension
- Route
- Oral
- Packs
- 60 tablets, 1 bottle, 5 tablets and 1 more
- Manufacturers
- NavintaBurel PharmaceuticalsEton Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Do not refrigerate. Store at 20° to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). After first opening of the bottle: Store at room temperature between 15°C and 30°C (59°F and 86°F). Keep the bottle tightly closed between openings in order to protect from moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A16AA05 Carglumic acid
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 20 December 2021
- Identifiers
- RxCUI 905390DailyMed set ID 59e73eb8-edf8-4fad-93c2-deb6b23497f8, 591f95ca-3d99-4fb6-a402-e5a383a746d0, 2aee4281-402b-4cd6-9e6a-08945262e1a1NDC 68475-006, 71863-114, 35573-459Application ANDA213395, ANDA213729
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 |
|---|---|---|---|
| 60 tablet, for suspension in 1 bottle | 35573-459-60 | Burel Pharmaceuticals | 19 December 2022 |
| 1 bottle in 1 carton / 60 tablet, for suspension in 1 bottle | 71863-114-60 | Eton Pharmaceuticals | 20 December 2021 |
| 5 tablet, for suspension in 1 bottle | 68475-006-01 | Navinta | 1 August 2022 |
| 60 tablet, for suspension in 1 bottle | 68475-006-02 | Navinta | 1 August 2022 |
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 Carglumic acid 200 mg tablet for oral suspension.
Clinical summary
Carglumic acid is a carbamoyl phosphate synthetase 1 activator indicated in pediatric and adult patients as adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency. MedsAcross supplies Carglumic acid 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 Carglumic acidFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Carbaglu prescribing information (Recordati Rare Diseases) · U.S. National Library of Medicine, DailyMed
- Carbaglu: European public assessment report (EPAR) · European Medicines Agency
- Ucedane: European public assessment report (EPAR) · European Medicines Agency
Need Carglumic acid 200 mg tablet for oral suspension 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.