Glimepiride Tablets Manufacturer India

What We Manufacture

Glimepiride Tablet — specifications & clinical context

Product Specifications

Generic Name	Glimepiride
Strength / Dosage	1mg · 2mg · 3mg · 4mg
Dosage Form	Tablet
Route of Administration	Oral
Pack Size	Strip of 10
Packaging	Alu-Alu cold form blister
Storage	Store below 25°C · Protect from moisture
Shelf Life	24 months
Manufacturing Facility	WHO-GMP Certified · Birkoni, Chhattisgarh
Regulatory Status	DCGI Approved · Manufacturing Licence Held
Available For	Contract manufacturing · Third-party manufacturing · Direct institutional supply

Clinical Context

Glimepiride is the most widely prescribed sulfonylurea in India — preferred over older generation sulfonylureas (Glibenclamide, Glipizide) due to lower hypoglycaemia risk, once-daily dosing and reduced weight gain. Used as second-line therapy after Metformin monotherapy failure and in Metformin + Glimepiride combination (one of India’s most prescribed antidiabetic combinations). Low-dose tablet requiring exceptional content uniformity.

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Why 9M India

How Glimepiride Tablet is manufactured at 9M India

WHO-GMP certified manufacturing process

Glimepiride is a very low-dose drug (1–4mg) requiring validated geometric dilution blending to achieve content uniformity within ±5% of label claim. Direct compression preferred. Alu-Alu cold form blister packaging used across all strengths due to moisture sensitivity. Content uniformity testing at each tablet press head during compression.
In-house QC release testing — every batch

Dissolution (>75% in 30 min) · Assay by HPLC · Content uniformity (essential — USP acceptance value <15) · Related substances · Microbial limits — all in-house.
Complete documentation within 24 hours

Manufacturing Licence · DCGI approvals · WHO-GMP Certificate · COA · COC · Stability data — pre-prepared, available within 24 hours.