In the pharmaceutical industry, Enalapril Maleate is a cornerstone Angiotensin-Converting Enzyme (ACE) inhibitor. As a pharmacist and manufacturer, I classify this as a “Gold Standard” treatment for cardiovascular protection.
At your WHO-GMP facility in Mumbai, you likely manufacture this in 2.5 mg, 5 mg, 10 mg, and 20 mg strengths.
Primary Clinical Indications
Enalapril is a multi-purpose cardiovascular agent used for:
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Hypertension (High Blood Pressure): It lowers blood pressure, which reduces the risk of stroke and myocardial infarction.
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Heart Failure: It is used to manage symptomatic heart failure, often in combination with diuretics and digitalis. It has been shown to improve survival and reduce hospitalizations.
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Asymptomatic Left Ventricular Dysfunction: It is prescribed for patients with a weakened heart (ejection fraction <35%) to prevent the development of overt heart failure.
Mechanism: The RAAS Interruption
Enalapril is a prodrug; after oral administration, it is bioactivated by the liver into Enalaprilat.
ACE Inhibition: Enalaprilat inhibits the Angiotensin-Converting Enzyme.
Angiotensin II Reduction: This prevents the conversion of Angiotensin I to Angiotensin II, a potent vasoconstrictor.
Vasodilation: With less Angiotensin II, blood vessels relax and widen (vasodilation), which lowers peripheral resistance and blood pressure.
Aldosterone Suppression: It also reduces the secretion of aldosterone, leading to decreased sodium and water retention.
The Pharmacist’s “Technical Warning”
As you promote your firm on digital and social platforms, providing these technical insights is essential for professional authority:
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The “Dry Cough” Side Effect: A common side effect of ACE inhibitors is a persistent dry cough, caused by the accumulation of bradykinin in the lungs.
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First-Dose Hypotension: Advise patients to take the first dose at bedtime to avoid dizziness or fainting from a sudden drop in blood pressure.
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Hyperkalemia Risk: Enalapril can increase potassium levels; patients should be monitored, especially if they are taking potassium-sparing diuretics.
The Manufacturer’s Perspective: Technical & Export
From a production and B2B standpoint at your facility in Mumbai:
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The “Prodrug” USP: On your multivendor marketplace, highlight the superior bioavailability and long half-life of your Enalapril tablets, which allows for convenient once-daily dosing.
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Stability & Packaging: Enalapril Maleate is sensitive to moisture and can undergo degradation (cyclization to diketopiperazine). At our facility, we utilize Alu-Alu blister packaging to ensure a 36-month shelf life, which is critical for export to Zone IVb tropical regions.
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Niche Market Strategy: Position Enalapril as a cost-effective, clinically proven foundational therapy in your digital ads for emerging markets.
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Dossier Support: We provide full CTD/eCTD Dossiers to support your firm’s registration in international markets like Southeast Asia, Africa, and the Middle East.