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2.3. A.1 Facilities and Equipments (Loprazolam 2 MG Tablets, PRIMEGEN Limited)

The document provides information on the quality and safety of Loprazolam 2 mg tablets manufactured by PRIMEGEN Limited. It states that facilities and equipment are not applicable. It also states that an adventitious agents safety evaluation is not applicable. Finally, it notes that no novel excipients were used in the formulation of the Loprazolam 2 mg tablets.

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43 views

2.3. A.1 Facilities and Equipments (Loprazolam 2 MG Tablets, PRIMEGEN Limited)

The document provides information on the quality and safety of Loprazolam 2 mg tablets manufactured by PRIMEGEN Limited. It states that facilities and equipment are not applicable. It also states that an adventitious agents safety evaluation is not applicable. Finally, it notes that no novel excipients were used in the formulation of the Loprazolam 2 mg tablets.

Uploaded by

nikjadhav
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
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Loprazolam 2 mg Tablets

2.3 Quality Overall Summary

2.3. A.1
Limited)

PRIMEGEN Limited
November 2014

Facilities and Equipments (Loprazolam 2 mg Tablets, PRIMEGEN

Not Applicable.

Loprazolam 2 mg Tablets
2.3 Quality Overall Summary

PRIMEGEN Limited
November 2014

2.3. A.2
Adventitious Agents Safety Evaluation (Loprazolam 2 mg Tablets,
PRIMEGEN Limited)
Not Applicable.

Loprazolam 2 mg Tablets
2.3 Quality Overall Summary

2.3. A.3

PRIMEGEN Limited
November 2014

Excipients

No novel excipients were used in the formulation.

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