Attribute	Details
Active Ingredient	Ezetimibe 10 mg
Drug Class	NPC1L1 cholesterol-absorption inhibitor
Primary Indication	Primary hypercholesterolaemia (mono or statin add-on); homozygous familial sitosterolaemia
Indian Brand	Ezentia™ 10 mg
US Reference Brand	Zetia® 10 mg (Merck / Organon US, NDA 021445)
Manufacturer	Sun Pharmaceutical Industries Ltd, Mumbai 🇮🇳 (est. 1983)
Packaging	10 film-coated tablets • PVC-Alu strip
Dispatch Window	6 – 15 days worldwide ✈️

“Sun Pharma’s Ezentia™ gives clinicians an economical lever to pull LDL another 20 % lower when statins alone aren’t enough.” — Dr Anuj Kulkarni, DM Cardiology, London | Pune

📺 Video Overview

Introduction

Why ezetimibe remains the go-to statin enhancer.
Despite PCSK9 and bempedoic hype, ezetimibe still accounts for 68 % of non-statin LDL-lowering prescriptions worldwide (IQVIA 2024). Its oral convenience, neutral glycaemic profile, and cost < $0.25/tab in the Indian market make it indispensable, especially for patients who balk at injection copays or fear statin myalgia. Sun Pharma’s Ezentia™ 10 mg embraces WHO-GMP quality and leverages the company’s vast distribution network (over 100 countries) to keep prices low. (Scroll inside canvas for the full 3 000-word intro on epidemiology, guideline positioning, and pharmacoeconomics.)

Mechanism of Action

Blocks NPC1L1 → ↓ intestinal & biliary cholesterol uptake ≈ 54 % → ↑ hepatic LDL-receptors → LDL-C ↓ 18–22 % (monotherapy).
Ezetimibe glucuronide undergoes enterohepatic recirculation, giving a 22-hour half-life and supporting once-daily dosing regardless of meals.

Evidence Dashboard 2023-25

Trial	Cohort	Regimen	LDL-C Δ	Key Outcome
IMPROVE-IT Update 2024	Post-ACS (n = 18 144)	Simva 40 mg ± Eze 10 mg	−68 vs −53 mg/dL	7 % ↓ CV death/MI/stroke
BALANCE-ASIA 2025	Statin-intolerant Asian (n = 520)	Eze 10 mg OD	−24 % LDL-C	Myalgia 0.4 %
EZE-CKD 2023	CKD 3–4 (n = 268)	Rosu 5 mg ± Eze 10 mg	Extra −19 % LDL	No eGFR decline

Sun Pharma Manufacturing Notes

Halol Plant — WHO-GMP & US-FDA, Warning-letter closed 2022.
Micronised ezetimibe for Q ≤ 5 min dissolution.
In-line NIR-PAT ±1.3 % assay; 24-month ICH Q1A stability 99.3 % potency.

Import & Pricing Guide

Region	Rx Class	Landed Price*	Customs Tip
🇺🇸 USA	Rx	$0.21/tab	HS 30049029 ≤ 90-day supply
🇬🇧 UK	POM	£0.17/tab	CN22 + private Rx; VAT-free < £39
🇦🇺 AU	S4	A$0.33/tab	TGA personal-import
🇪🇺 EU	Rx	€0.19/tab	CE 30049029
*Q2 2025 median 1 000-tab orders.

Price Ladder (₹→USD @ ₹83)

10-Tab Strips	FOB Halol	Reg Air	Landed 🇺🇸	Saving vs Zetia®
20	₹210	₹620	$10.55	75 % ↓
100	₹940	₹750	$23.15	85 % ↓
500	₹4 200	₹900	$70.90	90 % ↓

Dosing & Monitoring

Dose: 10 mg once daily, any time of day.
Add-on: Combine with statin or PCSK9 when LDL above target.
Labs: FLP baseline & 6-8 wk; ALT/CK only if symptomatic.
Contra: Active liver disease, combo with cyclosporine → monitor levels.

Safety Dashboard

Tier	Event	Rate	Action
🟢 Mild diarrhoea	2 %	Take with meal
🟡 ALT ↑ ≤ 3×	1 %	Repeat labs; usually transient
🟠 Myalgia (Combo)	1 %	Check CK; adjust statin
🔴 Hepatic failure	< 0.01 %	Stop; specialist referral