Omeprazole commands a market size of $7 billion and is marketed as an enteric release formulation.
The product is offered as a semi-finished formulation in a pelletized form. The API is manufactured under a strict control with stringent specifications on the impurity profile as well as the particle size not to mention, the use of correct polymorphs also. The excipients used are specifically chosen and are non-infringing. The product can also be offered in a pellet size suitable for use in a suspension or for compression in tablets.
The DMF file for Omeprazole Pellets 8.5% is submitted to the USFDA and is awaiting review.
The EDMF file for Omeprazole Pellets 8.5% is submitted with the National Authorities is Greece and Romania and is awaiting review.
Omeprazole Pellets 8.5% BA/BE Studies have been successfully completed by the end users.