Gliclazide, Indian WHO-GMP supply for type 2 diabetes formulary programmes.
Gliclazide was formally added to the WHO Model List of Essential Medicines in September 2025, replacing glibenclamide as the core-list second-generation sulfonylurea. M Care sources gliclazide 80 mg immediate-release and 30/60 mg modified-release tablets from WHO-GMP certified Indian manufacturers for procurement desks aligning formularies to the updated list.
Gliclazide exporter and bulk supplier from India.
Gliclazide moves through standard oral solid-dose logistics with no cold chain requirement, which keeps bulk shipment and storage straightforward for tender-volume orders spanning the 80 mg IR and 30/60 mg MR presentations. We coordinate sourcing across WHO-GMP certified Indian manufacturing sites to consolidate IR and MR formulations into a single shipment where a buyer's formulary calls for both.
Source
WHO-GMP-certified Indian manufacturing line, named on every quote.
Minimum order
No blanket MOQ. Set by the source manufacturer's minimum batch-release quantity for the strength and pack ordered.
Pricing
On request. Indicative FOB or CIF quote, formal proforma on confirmation.
Incoterms
EXW, FOB, CIF, CIP or DAP.
Payment
Letter of credit (sight or usance) and telegraphic transfer.
Documentation
WHO-GMP certificate of the source line, product-specific CoPP, batch CoA, method of analysis, Free Sale Certificate, Certificate of Origin, CTD or eCTD dossier. On request.
Shelf-life
Minimum remaining shelf-life agreed per order and confirmed on the proforma.
Response
Availability and CoPP status within two working days; pre-alert documents before dispatch.
80 mg IR tablets; 30 mg and 60 mg MR tablets. Standard oral solid-dose handling, no cold chain. Documentation pack built for WHO EML-aligned tender submission.
Active ingredient
Gliclazide. Second-generation sulfonylurea.
Forms and strengths
80 mg (immediate-release); 30 mg (modified-release); 60 mg (modified-release).
Indications
Gliclazide is a second-generation sulfonylurea used in type 2 diabetes management, available as 80 mg immediate-release tablets and 30 mg or 60 mg modified-release tablets. It formally replaced glibenclamide as the core-list second-generation sulfonylurea in the WHO Model List of Essential Medicines, 24th list (September 2025), and carries documented lower severe-hypoglycaemia rates than glibenclamide in a large elderly cohort study.
Storage and handling
80 mg IR tablets; 30 mg and 60 mg MR tablets. Standard oral solid-dose handling, no cold chain. Documentation pack built for WHO EML-aligned tender submission.
Documentation
Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.
Hospital pharmacies, licensed importers and tender desks across our export markets.
India is our origin. We do not sell into the Indian market.
We work with national and institutional procurement bodies updating essential medicines lists to reflect the WHO's September 2025 EML revision, hospital and tender desks in the Gulf, Africa, and SE Asia sourcing a second-generation sulfonylurea with a lower documented hypoglycaemia burden than glibenclamide, and importers building or replenishing type 2 diabetes formulary stock across IR and MR presentations.
GCC registration routes
Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.
UK unlicensed routes
Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.
Tender desks
Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.
Dossier support
CTD documentation from the sourcing manufacturer, compiled for your regulator's format.
What the dispensing pharmacist checks on gliclazide.
Gliclazide is available as 80 mg immediate-release tablets and as 30 mg or 60 mg modified-release tablets, per the UK SmPC/EMC labelling and the Health Canada monograph. The MR formulation is designed for once-daily dosing consistent with its extended-release profile; IR and MR products are not interchangeable on a milligram-for-milligram basis and prescribing should follow the specific product's labelling.
The clinical case for gliclazide over glibenclamide rests on hypoglycaemia risk. A large elderly cohort study found hospital encounters for hypoglycaemia occurred in 1.58% of glibenclamide patients versus 0.18% of gliclazide patients, an odds ratio of 8.63, a finding supported by network meta-analysis. This is a documented difference in severe-hypoglycaemia rates between the two agents, not a claim of superior glycaemic efficacy, and dispensing pharmacists should counsel patients on hypoglycaemia recognition regardless of which sulfonylurea is supplied.
As of the WHO's 24th Model List of Essential Medicines (published September 2025), gliclazide at 30/60/80 mg formally replaced glibenclamide as the core-list second-generation sulfonylurea. Formulary and tender desks updating specifications to match the current EML should expect gliclazide, not glibenclamide, as the listed agent going forward.
The documentation pack a regulator actually asks for.
M Care does not manufacture gliclazide. We source it from Indian manufacturing sites holding WHO-GMP certification and compile the documentation pack international buyers require: certificates of analysis, certificates of pharmaceutical product (CoPP), stability data, and manufacturing site GMP certificates for each batch and presentation.
Because gliclazide now sits on the WHO's core Model List of Essential Medicines (24th list, September 2025) as the designated second-generation sulfonylurea, tender specifications referencing WHO EML alignment can be matched directly against our supply. We provide the IR and MR strength-specific documentation separately where a tender specifies one presentation over the other, and coordinate directly with the sourcing manufacturer on any additional country-specific registration documents a buyer's regulator requires.
CoA and MoA, per batch
Batch-specific certificate and method of analysis from the sourcing manufacturer's QC release.
CoPP, WHO-GMP, MFG licence
Certificate of pharmaceutical product and site GMP certification issued via CDSCO channels, naming the actual manufacturing site.
CTD Module 3
Chemistry, manufacturing and controls documentation available from the sourcing manufacturer for registration filings.
Pack insert, labels, artwork
Destination-language patient information and labelling to the local regulator's standard, locked before shipment.
Pharmacovigilance
A named PV contact arranged in the destination market where the registration requires one.
Adjacent lines procurement desks order alongside gliclazide.
Dapagliflozin+metformin XR
Combination oral option for type 2 diabetes formularies stocking beyond sulfonylurea monotherapy.
Insulin glargine biosimilar
Basal insulin for patients progressing past oral agents on the same formulary.
Levothyroxine sodium
Commonly co-managed endocrine line item on the same institutional tenders.
Diabetes & endocrine category hub
Full category listing for procurement desks building a diabetes formulary order.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Form and strength, pack preference, destination market and indicative volume for gliclazide.
- We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
- Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
- Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
- After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Gliclazide supply, the specific questions.
What strengths and formulations of gliclazide can M Care supply?
80 mg immediate-release tablets and 30 mg or 60 mg modified-release tablets, matching the UK SmPC/EMC and Health Canada monograph presentations.
Is gliclazide on the WHO Model List of Essential Medicines?
Yes. Gliclazide (30/60/80 mg) formally replaced glibenclamide as the core-list second-generation sulfonylurea in the WHO Model List of Essential Medicines, 24th list, published September 2025.
Does M Care manufacture gliclazide?
No. M Care is a merchant exporter. We source gliclazide from WHO-GMP certified Indian manufacturers and manage export documentation and logistics; we do not hold manufacturing WHO-GMP or WHO-PQ certification ourselves.
How does gliclazide compare to glibenclamide on hypoglycaemia risk?
A large elderly cohort study found hospital encounters for hypoglycaemia in 1.58% of glibenclamide patients versus 0.18% of gliclazide patients (odds ratio 8.63), a finding supported by network meta-analysis. This reflects documented lower severe-hypoglycaemia rates for gliclazide, not a general efficacy claim.
What documentation is included for tender submission?
Certificates of analysis, certificates of pharmaceutical product (CoPP), stability data, and manufacturing site GMP certificates, compiled per batch and presentation for the sourcing manufacturer.
Does gliclazide require cold chain shipping?
No. Gliclazide is a standard oral solid-dose product and ships and stores under normal conditions without cold chain requirements.
Send the specifics. You'll have a price inside one working day.
Form and strength, destination market and indicative volume. The Mumbai desk replies within one working day, including when the honest answer is that the route is not viable yet.