-Lansoprazole is a proton pump inhibitor and is one of the blockbuster molecule used in the treatment of ulcer. The quality of the pellets is based on the in-vitro dissolution test besides the assay and the impurity profile.
-Pre-finished formulation of Lansoprazole is in form of pellets using Aqueous based technology.
-The dissolution values are direct measures of the coating efficiency and hence optimum therapeutic efficacy.
-Quality- Comparison with the Innovator.
-Variations of the Product Percentage: 7.5%, 8.5% and 10%
-Mesh Size: 12 to 14, 14 to 16, 16 to 18, 18 to 20, 20 to 22, 22 to 24, 24 to 30, 30 to 40, and 40 to 60 available.
Advantages:
-Ready to fill any size of capsules.
-No processing prior to capsule and dry syrup filling resulting in substantial cost and time saving.
-No organic solvents used during coating or at any other stage of manufacturing.
- Better in-vitro and in-vivo absorption profile (matching with innovator’s profile) for long term Pharmacological action.
-The plant has been audited & approved for GMP compliance as per ICH guidelines & manufacturing by European Union (EU), WHO-GMP; vide statutory site audits by Indian FDA, Local GMP issued by FDA.
-The only pelletization unit in India that has been accorded the status of being a 100% Export Oriented Unit (EOU).
Packaging Details: 25 Kg HDEP drum and Custom packing will be done.