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Soliqua 100/33 100 units/33 mcg per mL injection

Insulin glargine and Lixisenatide · Subcutaneous · Sanofi-Aventis
Available on requestPrescription onlyUS FDA Cold chain

Soliqua 100/33 100 units/33 mcg per mL injection is a prescription medicine containing Insulin glargine and Lixisenatide 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

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Cold chain

Prior to first use, SOLIQUA 100/33 pen should be stored in a refrigerator…

Key facts

Active ingredient (INN)
Insulin glargine and Lixisenatide
Brand
Soliqua 100/33
Strength
100 units/33 mcg per mL
Dosage form
Injection
Route
Subcutaneous
Packs
1 syringe, 5 syringes
Marketing authorisation holder
Sanofi-Aventis
Manufacturer
Sanofi-Aventis
Origin register
US FDA, United States
Storage
Prior to first use, SOLIQUA 100/33 pen should be stored in a refrigerator, 36°F–46°F (2°C–8°C). Do not freeze. After first use, store at room temperature up to 77°F (25°C). Protect from light. Replace the pen cap after each use to protect from light. Remove the needle after each injection and store the SOLIQUA 100/33 pen without a needle attached.
Cold chain
Yes, shipped temperature controlled
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
A10AE54 Insulin glargine and Lixisenatide
HS code (indicative)
3004.31Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
21 November 2016
Identifiers
RxCUI 1858995, 1859000DailyMed set ID 4bba538b-cf7c-4310-ae8f-cb711ed21bccNDC 0024-5761Application BLA208673

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

PackCodeLabelerMarketed since
1 syringe in 1 carton / 3 mL in 1 syringe0024-5761-01Sanofi-Aventis21 November 2016
5 syringe in 1 carton / 3 mL in 1 syringe0024-5761-05Sanofi-Aventis21 November 2016

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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 21 November 2016Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS 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

Clinical summary

Insulin glargine and Lixisenatide is a fixed-dose combination of a GLP-1 receptor agonist and an insulin analog. It is available as injection for subcutaneous use. MedsAcross supplies Insulin glargine and Lixisenatide 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 glargine and Lixisenatide

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Soliqua 100/33 100 units/33 mcg per 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.