Formulation Development
We can help companies primarily in the area of formulation research and Development
Formulation Tech Packages
We can provide Tech packages for many old and new API's to potential clients who are looking only for the Technology part of the formulation development.
And the Tech packages gives all the information as below:
- Introduction and Literature
- Quality overall summary
- Drug substance and specifications
- Drug Product
- Product development report
- Innovator characterization
- Dissolution profile
- Compatibility studies
- Manufacturing process and batch formula
- List of Equipment's and specifications
- Control on critical parameters
- Excipients specifications
- In process specifications
- Finished product specifications
- Analytical Standard testing procedures
- Stability data
- Packing details and specifications
- Bio equivalence summary and reports
Formulation Tech Transfers
We can provide Tech Packages as above plus Demonstrate 3 Exhibit batches at client site.
Outright Sale of ANDA's
This involves outright sale of ANDA's with complete transfer of ownerships to the clients.