- Dosage: 100 IU/mL, 3ml cartridge
- Volume: 3ml cartridge
- Packaging: Sterile cartridge for injection, 3ml cartridge/tray*1 box*10/catron
- Shelf Life: 36 months
Package:
Product Description
Insulin Glargine Injection 100IU/mL 3ml Cartridge: What the Published Guidance Says
Human and analogue insulins alongside the oral hypoglycaemics and cardiorenal-metabolic agents added to the WHO Model List in its September 2025 revision.
Insulin Glargine Injection 100IU/mL 3ml Cartridge sits in the Diabetes & Insulin range. The notes below are the ones that most often change a specification, a label or a tender submission.
- 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. WHO eEML — Medicines for diabetes
- 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. WHO — Essential medicines list updated to include key cancer and diabetes treatments (5 Sep 2025)
- 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). WHO — Essential medicines list updated to include key cancer and diabetes treatments (5 Sep 2025)
We quote these sources rather than paraphrase them loosely, because the detail matters commercially for Insulin Glargine Injection 100IU/mL 3ml Cartridge. Where your national list differs from the WHO listing, the national list governs what may be supplied and promoted locally.
Insulin Glargine Injection 100IU/mL 3ml Cartridge — Supply Parameters
| Product Name | Insulin Glargine Injection (Long-Acting Basal Insulin Analogue, Recombinant DNA Origin) |
| Specification | 100 IU/mL — 3mL Cartridge (300 IU total) |
| Dosage Form | Sterile, Nonpyrogenic, Clear, Colorless Aqueous Solution for Subcutaneous Injection (long-acting basal insulin analogue) |
| Active Ingredient | Insulin Glargine (recombinant DNA origin; human insulin analogue with A21 glycine substitution and two additional arginine residues at B30) |
| Pharmacological Class | Antidiabetic Agent / Pancreatic Hormone / Long-Acting Basal Insulin Analogue (Blood Glucose Regulating Agent) |
| Route of Administration | Subcutaneous injection only (abdomen, thigh, deltoid, or buttock). NOT for intravenous or intramuscular injection. NOT to be mixed with any other insulin formulation. |
| Storage | Unopened: Store refrigerated at 2°C to 8°C, protected from light. Do NOT freeze. In-use (opened): Store at room temperature (below 25°C) for up to 28 days, away from direct heat and light. Discard after 28 days even if unused. |
| Therapeutic group | Diabetes & Insulin — Diabetes & Insulin |
| Manufacturer | Sinophare Bio-technology Co., Ltd. (GMP, China) |
| Documentation supplied | COA, HPLC/GC data, stability data, dossier package |
The same therapeutic range is supplied in several presentations, so one purchase order can cover a mixed requirement: Mixed Protamine Human Insulin 30R, Isophane Protamine Human Insulin 100IU/mL 3ml, Human Insulin Injection 3ml 300IU Cartridge & 10ml 1000IU Vial, Dapagliflozin 10mg Tablets, Canagliflozin 300mg Tablets, Empagliflozin 25mg Tablets, Ertugliflozin 15mg Tablets, Finerenone 20mg Tablets.
Quality Control, Pharmacopoeial Standards & Documentation
Products are manufactured and tested against USP, EP, BP and CP monographs, with incoming raw-material inspection, in-process monitoring and full finished-product testing.
Every batch of Insulin Glargine Injection 100IU/mL 3ml Cartridge is tested to the monograph stated on the purchase order. Where a monograph is silent on the presentation, we agree a written specification with you in advance and reference it on the certificate of analysis.
Standardised GMP production workshops with an independent R&D laboratory and a complete quality-inspection centre.
A typical release panel for this presentation covers:
- Testing for heavy metals and elemental impurities
- Testing for packaging integrity and seal testing
- Testing for description and identification
- Testing for assay of the active substance
- Testing for related substances and impurities
- Testing for dissolution or release profile (solid oral forms)
COA, HPLC and GC data, DMF and dossier packages, plus registration support documents for national marketing-authorisation filings.
Packaging, Labelling & Export
- Pack size: 3mL glass cartridge (for use with compatible insulin pen devices). Non-standard pack sizes can be quoted against your artwork.
- Storage: Unopened: Store refrigerated at 2°C to 8°C, protected from light. Do NOT freeze. In-use (opened): Store at room temperature (below 25°C) for up to 28 days, away from direct heat and light. Discard after 28 days even if unused..
- Shelf life: 36 months (unopened, refrigerated). Stability data for the marketed pack is included in the dossier.
- Labelling: artwork can be produced in English, Arabic, French, Russian and Spanish, with your own brand and language mix, subject to the labelling rules of the destination market.
- Export: GMP certificate, COA, certificate of origin, packing list and, where required, the free-sale or marketing authorisation certificate from the country of manufacture.
Registration, Dossier & Tender Support
Documents for Insulin Glargine Injection 100IU/mL 3ml Cartridge are issued by Sinophare Bio-technology Co., Ltd. — DML Number Jin20160068 (medicines) and Jin20160069 (paracetamol API).. Keeping one legal manufacturer across the COA, the GMP certificate and the registration file avoids assessment queries later.
- CTD dossier modules 1–5 in editable and PDF form, with the finished-product and API sections cross-referenced.
- Site Master File and GMP certificate for the manufacturing workshops.
- Method validation, stability protocol and the shelf-life justification for the marketed pack.
- Answers to authority questions during assessment, handled by the regulatory contact who prepared the file.
- Tender and framework documentation, including pre-qualification questionnaires and sample logistics.
The context for Insulin Glargine Injection 100IU/mL 3ml Cartridge is its place among medicines for diabetes listed in the WHO Model List. Listing status informs how programmes specify a product; it is not a substitute for the import licence or marketing authorisation of the destination country.
Frequently Asked Questions
What pack size is available for Insulin Glargine Injection 100IU/mL 3ml Cartridge?
This presentation is normally supplied as 3mL glass cartridge (for use with compatible insulin pen devices). Where your market requires a different count, bottle or carton, we quote to your artwork and extend the stability file to the new pack.
What documentation comes with a shipment of Insulin Glargine Injection 100IU/mL 3ml Cartridge?
Shipments are accompanied by a certificate of analysis covering identification, assay and related substances, together with the marketed-pack stability data and the manufacturing site GMP certificate. Shelf life: 36 months.
Does the batch documentation for Insulin Glargine Injection 100IU/mL 3ml Cartridge support a registration filing?
Shipments are accompanied by a certificate of analysis covering identification, assay and related substances, together with the marketed-pack stability data and the manufacturing site GMP certificate. Shelf life: 36 months. The full CTD dossier and the authority assessment file are supplied as part of a registration order; routine shipments carry the COA and stability data only.
Do you supply human insulin as well as analogues?
Yes. We supply human short-acting, isophane and premixed 30/70 protamine human insulin, and insulin glargine. The Model List notes that quality-assured biosimilars are included in its analogue listings.
Which SGLT2 inhibitors do you supply?
Empagliflozin, dapagliflozin, canagliflozin and ertugliflozin in tablet form. Empagliflozin is the molecule specifically listed in section 18.5.2 of the Model List, with canagliflozin and dapagliflozin named as therapeutic equivalents.
Related Diabetes & Insulin Products
- Mixed Protamine Human Insulin 30R — 100IU
- Isophane Protamine Human Insulin 100IU/mL 3ml — 100IU
- Human Insulin Injection 3ml 300IU Cartridge & 10ml 1000IU Vial — 100IU
- Dapagliflozin 10mg Tablets — 10mg
- Canagliflozin 300mg Tablets — 300mg
- Empagliflozin 25mg Tablets — 25mg
Browse the full Diabetes & Insulin range; all Injectables; the complete product catalogue.
Request a Quotation for Insulin Glargine Injection 100IU/mL 3ml Cartridge
For tenders and programme supply, send the line item, pack size, quantity and destination for Insulin Glargine Injection 100IU/mL 3ml Cartridge 100IU. We return a quotation with lead time, documentation list and sample availability in one response.
Sources & Regulatory Notes
- WHO eEML — Medicines for diabetes
- WHO — Essential medicines list updated to include key cancer and diabetes treatments (5 Sep 2025)
Reference information only. The published guidance summarised on this page is quoted for professional and regulatory-context purposes and does not constitute medical advice, a prescribing recommendation or a promotion of any product for a particular indication. Prescribing decisions must follow the approved product information and national treatment guidelines in the market of use.
