Data Packages

Antacid Data Packages for Dossiers

SPI Pharma Can Provide:

  • Completed data package for 400mg Aluminum Hydroxide and 400mg Magnesium Hydroxide Antacid tablet under CTD format: Module 2 (summary relative to the Module 3) and Module 3. Available immediately. 
  • Bibliography to support the writing of Module 5. Available immediately.
  • Option to supply the finished product from our contract manufacturing partner (from India) or to transfer the production to other sites. Supply prices available. Stability data for 3 years on 3 batches is complete.
  • Process validation on 3 batches is complete.
  • Technical file is available upon request.

*We are looking for partners who would be interested to register and launch these products (standard formula and/or sugar free formula) in their territories.

Prescription Prospectus

Data packages include information for facilitating development of a commercial ODT product. SPI will be pleased to provide our know-how and laboratory capabilities to assist your development on a fee for service basis. SPI acknowledges that manufacturing in your equipment may yield different results. For further details please use our guide below: 

Prescription Prospectus Guide