Tablets Amlodipine Tablets Manufacturer

What We Manufacture

Amlodipine Tablet — specifications & clinical context

Product Specifications

Generic Name	Amlodipine Besylate
Strength / Dosage	2.5mg · 5mg · 10mg
Dosage Form	Tablet
Route of Administration	Oral
Pack Size	Strip of 10 · Bottle of 100
Packaging	Alu-PVC blister · Alu-Alu blister
Storage	Store below 30°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

Amlodipine is the most widely prescribed calcium channel blocker globally and the most prescribed antihypertensive in India. On the WHO Essential Medicines List. Indicated for hypertension (once-daily dosing) and stable angina. Long half-life (35-50 hours) enables once-daily dosing with excellent patient compliance. The 5mg starting dose and 10mg maximum dose are the most commonly prescribed strengths. Core government NHM hypertension programme drug and a standard CGHS formulary item.

Enquire Now

Why 9M India

How Amlodipine Tablet is manufactured at 9M India

WHO-GMP certified manufacturing process

Amlodipine tablets are low-dose formulations (2.5–10mg) requiring excellent content uniformity — validated blending with geometric dilution for 2.5mg tablets, blend uniformity sampling at multiple points per batch. Direct compression preferred where possible to minimise manufacturing steps. Amlodipine Besylate is light-sensitive — light-protective packaging required.
In-house QC release testing — every batch

Dissolution (>80% in 30 min) · Assay by HPLC (95.0–105.0%) · Content uniformity (essential for low-dose tablets, ±10% acceptance criterion) · Related substances · Microbial limits — all in-house.
Complete documentation within 24 hours

Manufacturing Licence · DCGI product approvals · WHO-GMP Certificate · Certificate of Analysis · Certificate of Conformance · Stability data (real-time and accelerated, ICH-aligned) — pre-prepared and available within 24 hours for tender submission, export registration or contract manufacturing due diligence.