Metformin Tablets Manufacturer India

What We Manufacture

Metformin Tablet — specifications & clinical context

Product Specifications

Generic Name	Metformin Hydrochloride
Strength / Dosage	500mg · 850mg · 1000mg (IR and ER)
Dosage Form	Immediate-Release Tablet · Extended-Release Tablet
Route of Administration	Oral
Pack Size	Strip of 10 · Bottle of 500
Packaging	Alu-PVC blister · HDPE bottle
Storage	Store below 25°C · Protect from moisture
Shelf Life	36 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

Metformin is the first-line pharmacological treatment for Type 2 diabetes in all major international guidelines — WHO Essential Medicines List. With 101 million diabetic patients in India and hundreds of millions more globally, Metformin is one of the highest-volume tablets in the world. The ER formulation reduces GI side effects (nausea, diarrhoea) significantly, improving patient compliance for long-term diabetes management.

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Why 9M India

How Metformin Tablet is manufactured at 9M India

WHO-GMP certified manufacturing process

Metformin IR tablets manufactured through direct compression — Metformin HCl has excellent tableting properties. Metformin ER tablets use validated HPMC matrix technology delivering controlled release over 24 hours. Large tablet masses (up to 2g total weight for 1000mg ER) require validated compression parameters for hardness and friability. Both IR and ER formats validated for multi-point dissolution profiling.
In-house QC release testing — every batch

IR: Dissolution (>80% in 30 min) · ER: Multi-point profile (20% at 1h, 45% at 4h, 70% at 8h, >80% at 12h) · Assay by HPLC · Related substances · Content uniformity · 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.