m2 3 a appendices
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7/23/2019 m2 3 a Appendices
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Loprazolam 2 mg Tablets PRIMEGEN Limited
2.3 Quality Oerall !ummary Noember 2"#$
2.3. A.1 Facilities and Equipments (Loprazolam 2 mg Tablets, P!"E#E$
Limited%
Not Applicable.
1
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Loprazolam 2 mg Tablets PRIMEGEN Limited
2.3 Quality Oerall !ummary Noember 2"#$
2.3. A.2 Ad&entitious Agents 'aet) E&aluation (Loprazolam 2 mg Tablets,
P!"E#E$ Limited%
Not Applicable.
2
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Loprazolam 2 mg Tablets PRIMEGEN Limited
2.3 Quality Oerall !ummary Noember 2"#$
2.3. A.3 E*cipients
No novel excipients were used in the formulation.
3