Diabetes, Insulin & Cardiorenal Metabolic Care
Human and analogue insulins alongside the oral hypoglycaemics and cardiorenal-metabolic agents added to the WHO Model List in its September 2025 revision.
The WHO Model List specifies human short-acting and intermediate-acting insulin down to the vial, cartridge and pre-filled pen format, with long-acting and rapid-acting analogues listed and quality-assured biosimilars included. Section 18.5.2 lists empagliflozin 10 mg and 25 mg, with canagliflozin and dapagliflozin as therapeutic equivalents.
At a glance
- Human short-acting, isophane and premixed 30/70 insulin, plus insulin glargine.
- The Model List specifies insulin at 40 IU/mL and 100 IU/mL in 10 mL vials and 100 IU/mL in 3 mL cartridges or pens.
- Empagliflozin 10/25 mg is listed; canagliflozin and dapagliflozin are named therapeutic equivalents.
- September 2025 added GLP-1 receptor agonists for type 2 diabetes with cardiovascular or kidney disease and obesity.
- Shipments travel temperature-controlled with temperature records provided for the whole consignment.
01What the published guidance says
Every statement below is drawn from WHO or MSF published material and linked to its source. We summarise; we do not reproduce. Statements marked as our own are commercial positions, not clinical guidance.
The Model List details the insulin presentations and strengths
Section 18.5.1 of the 24th WHO Model List (2025) lists human short-acting insulin as an injection solution of 40 IU/mL or 100 IU/mL in 10 mL vials and 100 IU/mL in 3 mL cartridges or pre-filled pens. Human intermediate-acting insulin is listed as an injection suspension in the same strengths, as compound insulin zinc suspension or isophane insulin. Long-acting and rapid-acting analogues are listed with glargine, degludec and detemir named among the therapeutic alternatives — a footnote notes that quality-assured biosimilars are included.
SGLT2 inhibitors are on the Model List
Section 18.5.2 lists empagliflozin as a 10 mg and 25 mg tablet for type 2 diabetes mellitus, with canagliflozin and dapagliflozin named as therapeutic equivalents.
September 2025 added the GLP-1 class
WHO added the GLP-1 receptor agonists semaglutide, dulaglutide and liraglutide, and the dual GLP-1/GIP agonist tirzepatide, for adults with type 2 diabetes where cardiovascular disease or chronic kidney disease is established and obesity is present (BMI ≥ 30 kg/m²).
The scale of the access problem
WHO reports that more than 800 million people were living with diabetes in 2022, with half going untreated, and that more than one billion people worldwide are affected by obesity with rates rising fastest in low- and middle-income countries.
02Products in this therapeutic group
Each entry links to its full specification page.
| Product | Dosage form | Presentation notes | Detail |
|---|---|---|---|
| Human Insulin Injection | Injection | View Human Insulin Injection → | |
| Isophane Protamine Human Insulin | Injection | View Isophane Protamine Human Insulin → | |
| Insulin Glargine Injection | Injection | View Insulin Glargine Injection → | |
| Sotagliflozin 400mg tablets | Tablet | View Sotagliflozin 400mg tablets → | |
| Repaglinide 2 mg Tablets | Tablet | View Repaglinide 2 mg Tablets → | |
| Finerenone 20 mg tablets | Tablet | View Finerenone 20 mg tablets → | |
| Ertugliflozin tablets 15mg | Tablet | View Ertugliflozin tablets 15mg → | |
| Empagliflozin 25mg Tablets | Tablet | View Empagliflozin 25mg Tablets → | |
| Canagliflozin 300mg Tablets | Tablet | View Canagliflozin 300mg Tablets → | |
| Dapagliflozin 10mg Tablets | Tablet | View Dapagliflozin 10mg Tablets → | |
| Mixed Protamine Human Insulin 30R | Injection | 30/70 Premixed Diabetes Injection | View Mixed Protamine Human Insulin 30R → |
11 products in this group · part of 186 finished dosage forms across 14 therapeutic areas.
03Specifying your order
The five things worth stating on a purchase order for this group, so the quotation comes back right first time.
Insulin classification
State human or analogue, and the release profile. Two insulins with similar names can have very different onset and duration.
Concentration
Specify 40 IU/mL or 100 IU/mL. Supplying the wrong concentration is a recognised patient-safety hazard.
Container platform
Vial, cartridge or pre-filled pen. The device is a separate regulatory object from the insulin and needs its own registration.
Cold chain
Confirm the destination's temperature requirements and whether continuous temperature records must accompany the shipment.
Device compatibility
If a pen is required, confirm which needle platform and pen body your market has approved.
04How we supply it
Standardised GMP production workshops with an independent R&D laboratory and a complete quality-inspection centre.
Insulin range
Human short-acting, isophane (intermediate-acting) and premixed 30/70 protamine human insulin, plus insulin glargine.
Cold chain
Insulins are shipped under temperature-controlled conditions with shipment temperature records. Confirm the cold-chain requirement for your route before ordering.
Oral and cardiorenal
SGLT2 inhibitors, repaglinide and finerenone across tablet strengths aligned to the Model List where listed.
Registration support
DMF and dossier packages, COA with assay and impurity data, and registration support documents for insulin and oral hypoglycaemic filings.
05Safety, labelling & regulatory notes
Points worth carrying into your tender, label review or clinical briefing.
- Insulin is a biologic: store at 2 °C to 8 °C before opening, do not freeze, and request temperature records for the entire shipment.
- Two insulins with similar names can carry very different release profiles. Specify the exact INN, strength, formulation (solution or suspension) and container on the purchase order.
- Confirm the pre-filled pen or cartridge platform is registered in your market — the device is a separate regulatory object from the insulin itself.
- Not every molecule on this page is on the WHO Model List. Confirm current listing status for the specific product against the Model List and your national essential medicines list.
06Questions buyers ask
6 answers covering specification, documentation and regulatory questions for this group.
Do you supply human insulin as well as analogues?
Which SGLT2 inhibitors do you supply?
How is insulin shipped?
Can you support an insulin registration dossier?
Do you supply premixed human insulin?
Which SGLT2 inhibitors do you supply?
07Related therapeutic areas
Adjacent groups you may want to combine on one purchase order.
Request a quotation for Diabetes & Insulin
Send us the products, strengths and pack sizes you need, together with the destination country, and we will return a quotation with the documentation package and lead time. Registration support documents are provided with every order.
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