Dear All,
We are researching in the following products.
Can you help with us?
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.
Trace Elements List CAS No Quantity Amounts Document Informations
Ferrous (II) Chloride Tetrahydrate
(There may also be different types of hydrates) 13478-10-9 500 g
Zinc Chloride 7646-85-7 500 g
Manganese (II) Chloride Tetrahydrate 13446-34-9 25 g
Cupric Chloride Dihydrate
(There may also be different types of hydrates) 10125-13-0 250 g
Chromic (III) Chloride Hexahydrate 10060-12-5 250 g
Sodium Molybdate Dihydrate 10102-40-6 25 g
Sodium Selenite Pentahydrate
(There may also be different types of hydrates) 26970-82-1 25 g
Sodium Fluoride 7681-49-4 25 g
Potassium Iodine 7681-11-0 25 g
