Medicine
Sovuna 300 mg tablet
Sovuna 300 mg tablet is a prescription medicine containing Hydroxychloroquine for oral use, marketed by ANI Pharmaceuticals, 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 room temperature between 20°C and 25°C (68°F and 77°F), allow…
Key facts
- Active ingredient (INN)
- Hydroxychloroquine
- Brand
- Sovuna
- Strength
- 300 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets
- Marketing authorisation holder
- ANI Pharmaceuticals
- Manufacturer
- ANI Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at room temperature between 20°C and 25°C (68°F and 77°F), allow excursions between 15°C and 30°C (59°F and 86°F). Storage Dispense in a tight, light-resistant container as defined in the USP/NF.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- P01BA02 Hydroxychloroquine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 15 September 2023
- Identifiers
- RxCUI 979092, 2569283, 2665282 +1DailyMed set ID dd441154-b196-4d4c-bc56-2e37f345ef8dNDC 70954-805Application NDA214581
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 |
|---|---|---|---|
| 100 tablet, film coated in 1 bottle | 70954-805-10 | ANI Pharmaceuticals | 15 September 2023 |
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 |
| US FDA | First approved 18 April 1955 | Drugs@FDA |
| 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 Hydroxychloroquine 300 mg tablet.
Other strengths and forms of Hydroxychloroquine
Clinical summary
Hydroxychloroquine is an antimalarial indicated for the treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients, among other approved uses. MedsAcross supplies Hydroxychloroquine 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 HydroxychloroquineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Plaquenil prescribing information (Advanz Pharma) · U.S. National Library of Medicine, DailyMed
Need Sovuna 300 mg tablet 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.