Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello All,

How many submission batches would be needed for an ANDA submission for a product with multiple strength and flavors. For example: If a product has two strengths X and Y and 3 flavors A, B & C.

Would it be required to make:

1) 3 batches of strength X with flavor A
2) 3 batches of strength Y with Flavor A
3) 3 batches of strength X with flavor B
4) 3 batches of strength Y with Flavor B
5) 3 batches of strength X with flavor C
6) 3 batches of strength Y with Flavor C

Or would it be satisfactory to make 6 batches with flavor A and 1 batch of each strength with flavor B and C?

Please note that both strengths X and Y are proportionally similar.


Thank you.

It would be satisfactory to make 6 batches with flavor A and 1 batch of each strength with flavor B and C.

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Gaurang Bhavsar, MS, RAC
Manager, R&D and RA
Sunrise Pharmaceutical, Inc.
Rahway, NJ 07065
USA
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Original Message:
Sent: 05-Mar-2019 11:50
From: Anonymous Member
Subject: Exhibit batch requirements ANDA

This message was posted by a user wishing to remain anonymous

Hello All,

How many submission batches would be needed for an ANDA submission for a product with multiple strength and flavors. For example: If a product has two strengths X and Y and 3 flavors A, B & C.

Would it be required to make:

1) 3 batches of strength X with flavor A
2) 3 batches of strength Y with Flavor A
3) 3 batches of strength X with flavor B
4) 3 batches of strength Y with Flavor B
5) 3 batches of strength X with flavor C
6) 3 batches of strength Y with Flavor C

Or would it be satisfactory to make 6 batches with flavor A and 1 batch of each strength with flavor B and C?

Please note that both strengths X and Y are proportionally similar.


Thank you.