The documents we request for the following raw materials are as follows:

• Excipient GMP (Excipact GMP certificate issued by an independent organization with a GMP audit)
• Polifarma needs to inspect the relevant facilities (PF can recognize the GMP audit they have previously undergone, and the report can also be purchased, the situation will be determined)
• If there is a CEP in the excipient status, it would be great.

• If there is no CEP, even if it is in the excipient status, a general DMF with all parts open is required. Stability data should be provided long-term and expedited.
• LoA
• LoE
• TSE/BSE
• Non-GMO documents are requested.