Amlodipine Capsule Manufacturer in India

About

About Amlodipine Capsules — 9M India

9M India manufactures Amlodipine Besylate hard gelatin capsules at its WHO-GMP certified facility in Birkoni, Chhattisgarh. Amlodipine is a long-acting dihydropyridine calcium channel blocker and one of the most widely prescribed antihypertensive and antianginal agents globally. Available in 5mg and 10mg strengths, our capsules conform to BP/USP pharmacopoeial standards with complete in-house analytical testing, stability data and export documentation.

Capsule formulation specifications

Specification	Details
Molecule	Amlodipine Besylate
Dosage Form	Hard Gelatin Capsule
Available Strengths	5mg, 10mg
Pharmacopoeial Standard	BP / USP / IP
Therapeutic Class	Cardiovascular — Calcium Channel Blocker (Antihypertensive)
Pack Options	10 capsules / 15 capsules per strip; bulk packs available
Storage	Store below 30°C, protect from moisture
Shelf Life	24 months
MOQ	As per enquiry — contact us

Therapeutic use & clinical indications

Amlodipine blocks voltage-gated L-type calcium channels in vascular smooth muscle and cardiac muscle, resulting in peripheral vasodilation, reduced peripheral vascular resistance and lowering of blood pressure. Its long half-life (35–50 hours) permits once-daily dosing with stable plasma levels.

Primary Indications:

Hypertension — mild to moderate
Chronic stable angina pectoris
Vasospastic angina (Prinzmetal’s angina)
Combination antihypertensive therapy — with ACE inhibitors, ARBs, diuretics

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Export Markets & Regulatory

Export markets & regulatory readiness

9M India exports Omeprazole capsules to regulated and semi-regulated markets across the Middle East, CIS countries, Africa, ASEAN and Latin America. All formulations are manufactured under WHO-GMP conditions and supported by complete regulatory documentation including CTD/ACTD dossiers, Certificate of Pharmaceutical Product (CoPP), Free Sale Certificate (FSC), and Certificate of Analysis (CoA).

WHO-GMP Certificate
DCGI Manufacturing Licence
Certificate of Pharmaceutical Product (CoPP)
Certificate of Analysis (CoA) — batch-wise
CTD / ACTD Dossier — on request
Stability Data — ICH Zone IVb (30°C/75% RH)

Partner with 9M India for Amlodipine capsule supply

Whether you are a pharmaceutical distributor, institutional buyer, government procurement agency or export partner, 9M India is equipped to supply Amlodipine capsules at scale — with full regulatory support and flexible packaging options.

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WHO-GMP
Certified
Export
Ready
15+ Countries
Supplied
DCGI
Approved

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We keep answer short

Frequently asked questions — Amlodipine capsules

01

Yes. 9M India manufactures Amlodipine Besylate hard gelatin capsules in 5mg and 10mg strengths at its WHO-GMP certified facility in Birkoni, Chhattisgarh. The formulation is DCGI approved and exported to cardiovascular markets across the Middle East, CIS, Africa and ASEAN.
02

9M India manufactures Amlodipine Besylate hard gelatin capsules in 5mg and 10mg strengths. The 5mg dose is the standard starting dose for hypertension and angina, with 10mg used where additional blood pressure lowering is required.
03

Yes. Amlodipine is listed on the WHO Model List of Essential Medicines for cardiovascular disease management. 9M India manufactures to WHO-GMP standards and can supply to institutional and government procurement programmes with the required documentation.
04

Amlodipine has an exceptionally long plasma half-life of 35 to 50 hours, allowing once-daily dosing with stable therapeutic blood levels throughout the 24-hour period. This is a key compliance advantage, particularly for chronic hypertension management in resource-limited settings.
05

9M India manufactures Amlodipine as a standalone capsule and also in combination tablet formulations with Atenolol, Losartan, Telmisartan and Atorvastatin. Please contact our export team for the full cardiovascular portfolio including combination products.
06

Documentation available includes WHO-GMP Certificate, DCGI Manufacturing Licence, CoPP, batch-wise CoA, ICH Zone IVb stability data and CTD/ACTD dossiers on request. Our team can support market registration in both semi-regulated and regulated markets.