Description

Omeprazole EP

Omeprazole EP is a high-purity proton pump inhibitor (PPI) used in oral pharmaceutical formulations to treat gastric acid-related conditions such as gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome.

• It is compliant with European Pharmacopoeia (Ph. Eur.) standards
• It effectively suppresses gastric acid secretion by inhibiting H⁺/K⁺-ATPase enzyme
• It is suitable for delayed-release capsules, tablets, and combination formulations
• It is manufactured under cGMP-certified conditions
• It is supplied with full regulatory documentation, including CoA

Omeprazole EP acts as a selective and irreversible inhibitor of the gastric proton pump, reducing gastric acid production at the source. Its delayed-release profile is critical to ensure acid resistance and proper absorption in the small intestine. Omeprazole is a cornerstone therapy in managing acid-peptic diseases and is frequently used in conjunction with antibiotics to eradicate Helicobacter pylori infections.

This API is commonly formulated using enteric coatings to ensure bioavailability and protect against degradation in low-pH environments. CarboMer supplies Omeprazole EP with defined particle size and polymorphic consistency to meet formulation performance needs.

CarboMer provides Omeprazole EP in bulk formats suited for development and large-scale commercial production.

Every batch is tested to Ph. Eur. monograph requirements for identity, potency, dissolution, related substances, and microbial quality. Regulatory documentation supports EU submission strategies and includes full impurity profiling, method validation, and stability protocol alignment.

As with all CarboMer APIs, Omeprazole EP is backed by a team of experts offering regulatory, analytical, and formulation support to streamline development timelines and ensure commercial success.