Medicine
Sirolimus 1 mg/mL oral solution
Sirolimus 1 mg/mL oral solution 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. 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
Sirolimus oral solution bottles should be stored protected from light and…
Key facts
- Active ingredient (INN)
- Sirolimus
- Brand
- Sold under the generic name
- Strength
- 1 mg/mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 1 carton, 1 bottle and 6 more
- Manufacturers
- Camber PharmaceuticalsIndiaNovadoz PharmaceuticalsIndiaAmneal Pharmaceuticals NYApotexBryant Ranch PrepackMylan PharmaceuticalsNorthStar RxRising Pharma HoldingsVistaPharm
- Origin register
- US FDA, United States
- Storage
- Sirolimus oral solution bottles should be stored protected from light and refrigerated at 2°C to 8°C (36°F to 46°F). If necessary, the patient may store the bottles at room temperatures up to 25°C (77°F) for a short period of time (e.g., not more than 15 days for the bottles).
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L04AH01 Sirolimus
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 28 January 2019
- Identifiers
- RxCUI 314230DailyMed set ID 384cb547-55a4-47fc-a0a6-054c18a51b84, 400da0a5-2a85-44ab-a2c5-bb9161750db3, f9843d49-0e16-4427-9cea-9f66f32b97f7 +6NDC 59762-1205, 16571-806, 72162-2641 +6Application NDA021083, ANDA215116, ANDA216728 +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 carton in 1 kit / 1 bottle, glass in 1 carton / 60 mL in 1 bottle, glass | 31722-316-31 | Camber PharmaceuticalsIndia | 16 September 2024 |
| 1 bottle, glass in 1 carton / 60 mL in 1 bottle, glass | 72205-099-78 | Novadoz PharmaceuticalsIndia | 14 February 2023 |
| 1 carton in 1 kit / 1 bottle, glass in 1 carton / 60 mL in 1 bottle, glass | 69238-1594-3 | Amneal Pharmaceuticals NY | 25 October 2019 |
| 1 bottle, glass in 1 carton / 60 mL in 1 bottle, glass | 60505-6197-2 | Apotex | 20 May 2020 |
| 1 carton in 1 kit / 1 bottle, glass in 1 carton / 60 mL in 1 bottle, glass | 59762-1205-6 | Mylan Pharmaceuticals | 22 July 2019 |
| 1 carton in 1 kit / 1 bottle, glass in 1 carton / 60 mL in 1 bottle, glass | 16571-806-06 | Rising Pharma Holdings | 15 July 2025 |
| 1 carton in 1 kit / 1 bottle in 1 carton / 60 mL in 1 bottle | 66689-347-02 | VistaPharm | 28 January 2019 |
| 1 bottle, glass in 1 carton / 60 mL in 1 bottle, glass | 72162-2641-6 | Bryant Ranch Prepack | 6 May 2026 |
| 1 bottle, glass in 1 carton / 60 mL in 1 bottle, glass | 72603-409-01 | Northstar Rx | 1 November 2025 |
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
Other strengths and forms of Sirolimus
Clinical summary
Sirolimus is a kinase inhibitor indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants, among other approved uses. MedsAcross supplies Sirolimus 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 SirolimusFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Sirolimus prescribing information (Mylan Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Hyftor: European public assessment report (EPAR) · European Medicines Agency
- Rapamune: European public assessment report (EPAR) · European Medicines Agency
Need Sirolimus 1 mg/mL oral solution 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.