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Drug product components:-
- Drug substance: or active pharmaceutical ingredient (API) which is responsible for pharmacological action.
- Inactive ingredient: or excipients which help the active ingredients to give the required action in the suitable time and place inside the human body in addition of some roles related to manufacturing facilitating and stabilizing of active ingredients from degradation.
- Primary packaging materials: the material which are in direct contact with the pharmaceutical dosage form as PVC/PVdC, Alu, HDPE bottle, glass bottle, Vial glass.
- Secondary packaging materials: the second packaging material which is not in contact with the pharmaceutical dosage form as product box.
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