Medicine
Semglee 100 IU/mL injection
Semglee 100 IU/mL injection is a prescription medicine containing Insulin glargine for subcutaneous use, marketed by Biocon Biologics, 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
Store unused SEMGLEE in a refrigerator between 2° to 8°C (36° to 46°F). Do not…
Key facts
- Active ingredient (INN)
- Insulin glargine
- Brand
- Semglee
- Strength
- 100 IU/mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 1 vial, 1 syringe, 5 syringes
- Marketing authorisation holder
- Biocon Biologics
- Manufacturer
- Biocon BiologicsIndia
- Origin register
- US FDA, United States
- Storage
- Store unused SEMGLEE in a refrigerator between 2° to 8°C (36° to 46°F). Do not freeze. Storage conditions are summarized in the following table: Not in-use (unopened) Refrigerated (2° to 8°C [36° to 46°F]) Not in-use (unopened) Room Temperature (up to 30°C [86°F]) In-use (opened) 10 mL multiple-dose vial Until expiration date 28 days 28 days Refrigerated or room temperature 3 mL…
- 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
- 28 July 2023
- Identifiers
- RxCUI 2563971, 2563973, 2563976 +1DailyMed set ID 8cf5544f-87d6-468b-f6ae-898b1fdb5d80NDC 83257-012, 83257-011Application BLA761201
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 |
|---|---|---|---|
| 1 vial, multi-dose in 1 carton / 10 mL in 1 vial, multi-dose | 83257-011-11 | Biocon BiologicsIndia | 28 July 2023 |
| 1 syringe in 1 carton / 3 mL in 1 syringe | 83257-012-31 | Biocon BiologicsIndia | 28 July 2023 |
| 5 syringe in 1 carton / 3 mL in 1 syringe | 83257-012-33 | Biocon BiologicsIndia | 28 July 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 100 IU/mL injection.
- Insulin glargine 100 IU/mL injectionAvailable on request—US FDA8 packs Cold chain
- Lantus Solostar 100 IU/mL injectionAvailable on requestSanofi-AventisUS FDA3 packs Cold chain
- Lantus 100 IU/mL injectionAvailable on requestSanofi-AventisUS FDA2 packs Cold chain
- Rezvoglar KwikPen 100 IU/mL injectionAvailable on requestEli LillyUS FDA2 packs Cold chain
- BASAGLAR KwikPen 100 IU/mL injectionAvailable on requestEli LillyUS FDA1 pack Cold chain
- Langlara 100 IU/mL injectionAvailable on requestLanexa BiologicsUS FDA1 pack Cold chain
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 Semglee 100 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.