Omeprazole Capsule Manufacturer in India

About

About Omeprazole Capsules — 9M India

9M India manufactures Omeprazole enteric-coated pellet hard gelatin capsules at its WHO-GMP certified facility in Birkoni, Chhattisgarh. Omeprazole is a proton pump inhibitor (PPI) and one of the most prescribed gastroenterological medicines globally. The enteric-coated pellet capsule formulation protects the active ingredient from gastric acid degradation, ensuring full bioavailability in the small intestine. Available in 20mg and 40mg strengths, our capsules conform to BP/USP standards with full stability data and export documentation.

Capsule formulation specifications

Specification	Details
Molecule	Omeprazole
Dosage Form	Hard Gelatin Capsule — Enteric-coated pellets
Available Strengths	20mg, 40mg
Pharmacopoeial Standard	BP / USP / IP
Therapeutic Class	Gastrointestinal — Proton Pump Inhibitor (PPI)
Pack Options	14 capsules / 28 capsules per strip; bulk packs available
Storage	Store below 25°C, protect from moisture
Shelf Life	24 months
MOQ	As per enquiry — contact us

Therapeutic use & clinical indications

Omeprazole irreversibly inhibits the H+/K+ ATPase enzyme system (the proton pump) on gastric parietal cells, suppressing both basal and stimulated gastric acid secretion. The enteric-coated pellet design ensures the drug bypasses gastric acid and is absorbed in the small intestine.

Primary Indications:

Gastro-oesophageal reflux disease (GERD)
Peptic ulcer disease — gastric and duodenal
Helicobacter pylori eradication — combination regimens
Zollinger-Ellison syndrome
NSAID-associated gastropathy — prevention and treatment
Stress ulcer prophylaxis in ICU patients

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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 Omeprazole capsule supply

Whether you are a pharmaceutical distributor, institutional buyer, government procurement agency or export partner, 9M India is equipped to supply Omeprazole 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 — Omeprazole capsules

01

Yes. 9M India manufactures Omeprazole enteric-coated pellet hard gelatin capsules at its WHO-GMP certified facility. The enteric-coated pellet design protects the active ingredient from gastric acid degradation, ensuring full bioavailability in the small intestine. Available in 20mg and 40mg strengths.
02

Omeprazole is acid-labile and degrades rapidly in gastric acid. Enteric-coated pellet capsules contain hundreds of tiny pellets individually coated with an acid-resistant polymer, ensuring the drug bypasses the stomach and dissolves in the small intestine. This design provides more reliable and consistent absorption compared to simple tablet formulations.
03

9M India manufactures Omeprazole enteric-coated pellet capsules in 20mg and 40mg strengths. The 20mg dose is standard for GERD and ulcer prevention, while 40mg is used for more severe conditions including Zollinger-Ellison syndrome and H. pylori eradication regimens.
04

Yes. Omeprazole is listed on the WHO Model List of Essential Medicines. 9M India actively supplies institutional buyers, hospital procurement departments and government programmes with Omeprazole capsules at scale, with full documentation support.
05

Omeprazole capsules are available in 14-capsule and 28-capsule strips as standard retail pack formats. Bulk institutional packaging is available for hospital and tender supply. Custom pack formats can be arranged — please contact our export team with specific requirements.
06

Yes. Stability studies for Omeprazole capsules are conducted per ICH Zone IVb conditions (30°C/75% RH), which is applicable to most tropical and subtropical export markets. Real-time and accelerated stability data is available as part of the regulatory dossier package.