Omeprazole Pellets 8.5%, 10%, 20%, 22%, 22.5%, 30% – Suitable for Capsules (Dose: 10 mg, 20 mg, 40 mg)

Omeprazole is a widely used proton pump inhibitor that is used in the treatment of peptic ulcers.

  • Omeprazole delayed-release oral suspension is a proton pump inhibitor (PPI). It works by decreasing the amount of acid produced in the stomach.
  • The product developed is comparable with innovator with respect to dissolution profile of the marketed product.
  • We offer complete technical package for registrations in all regulated/semi regulated markets
  • 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.
  • Products protected by ongoing Patents are not offered by MKPPL.

 



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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.

Registrations:
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.

Additional information
Percentage

8.5%, 10%, 20%, 22%, 22.5%, 30%

Mesh Size

12#16, 12#14, 14#18, 16# 20, 18#20, 20#24, 24#30, 30#40, 40#60

Release Type

Delayed Release

Target Formulations

Capsules, Tablets

Documentation Available:

DMF in CTD Format

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