Omeprazole 20mg capsules (e/c) PAC/100

General Description
Omeprazole 20mg capsules (e/c), blister of 10 capsules, pack of 100 capsules

Technical Specifications
The capsule should contain 20mg Omeprazole complying with one of the pharmacopeias:
·BP
·Ph. Eur.
·USP
The capsules should comply with one of the pharmacopeias:
·Gastro-resistant Omeprazole Capsules BP, general monograph for capsules and general notices
·Ph.Eur. general monograph for capsules and general notices
·Ph.Int. general monograph for capsules and general notices
·Omeprazole Delayed-Release Capsules USP and general notices and requirements

Preference will be given to formulations with long term stability studies conducted under Zone IV b conditions. If formulation with long term stability studies conducted under zone IVa is awarded, the manufacturer is expected to commit to initiate long term stability studies under zone IVb conditions.

Packaging and Labelling
As per UNICEF Technical Requirements.
Patient information leaflet should be included in each pack.