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: