This message was posted by a user wishing to remain anonymous
If the approval letter for API B via post approval PAS did not mention the expiry date it is assumed as 24 months similar to API A, then submit it in the AR for both API A and B to extend the expiry for DP to 36 months since the post approval stability protocol already covers till 36 months and API A has 36 month real time data.!
Original Message:
Sent: 17-Sep-2023 22:31
From: SUJAN BOSE
Subject: Shelf life extension
The second API was approved as a part of PAS.
Yes, for API A, stability protocol was approved covering 36 months.
In the approval letter for API B there is nothing written about shelf life.
The API A has 36 months data and API B has 18 months (real time) data. We are planning for 36 months expiry for the both sources.
Please advice.
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SUJAN BOSE
M.Pharm
Original Message:
Sent: 14-Sep-2023 08:49
From: Anonymous Member
Subject: Shelf life extension
This message was posted by a user wishing to remain anonymous
Was the second API approved as part of original ANDA or post approval?
For the API A, if the stability protocol in the ANDA was approved covering the proposed 36/48 etc. month expiry, then its AR.
If the API B was approved post approval, then check the approval letter it probably said 24?
Original Message:
Sent: 16-Jun-2017 04:55
From: Anonymous Member
Subject: Shelf life extension
This message was posted by a user wishing to remain anonymous
How confident you are in shelf life extension of finished product in below scenario.
Pdt has two approved API source. Existing expiry of finished product is 24 months.
- Available finished product stability data (long term) with API A- 36 months
- Available finished product stability data (long term) with API B- 12 months
If extension seems feasible, What category it could fall for Europe and US?