Medicine
Insulin glargine U-300 300 IU/mL injection
Insulin glargine U-300 300 IU/mL injection is a prescription medicine containing Insulin glargine for subcutaneous use, marketed by Sanofi-Aventis, 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
conditions are summarized in the following table: Insulin Glargine, U-300 Not…
Key facts
- Active ingredient (INN)
- Insulin glargine
- Brand
- Insulin glargine U-300
- Strength
- 300 IU/mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 3 syringes
- Marketing authorisation holder
- Sanofi-Aventis
- Manufacturer
- Sanofi-Aventis
- Origin register
- US FDA, United States
- Storage
- conditions are summarized in the following table: Insulin Glargine, U-300 Not in-use (unopened) Refrigerated 36°F–46°F (2°C–8°C) In-use (opened) To prevent degradation, always store the prefilled pens with the cap on during in-use period.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A10AE04 Insulin glargine
- HS code (indicative)
- 3004.31Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 April 2023
- Identifiers
- RxCUI 1604539, 2002419DailyMed set ID 99ea856d-9562-443a-9422-1006a3cff2f4NDC 0955-3900Application BLA206538
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 |
|---|---|---|---|
| 3 syringe in 1 carton / 1.5 mL in 1 syringe | 0955-3900-03 | Sanofi-Aventis | 1 April 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.
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 Insulin glargine 300 IU/mL injection.
Other strengths and forms of Insulin glargine
Clinical summary
Insulin glargine is an insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. MedsAcross supplies Insulin glargine 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 Insulin glargineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- BASAGLAR KwikPen prescribing information (Eli Lilly) · U.S. National Library of Medicine, DailyMed
- Lantus: European public assessment report (EPAR) · European Medicines Agency
- Toujeo (previously Optisulin): European public assessment report (EPAR) · European Medicines Agency
Need Insulin glargine U-300 300 IU/mL injection 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.