Hi Mehul;
If you propose to add additional source of api for the same drug substance then you should provide the following cmc information.
- comparision n justification of comparibility of physiochemical properties n impurities of the drug substance from each source.
- stability from 3 batches of drug product from first api source used in BE studies
- A single pilot scale batch of Drug product bio strength manf by using second api source.
- stab data on the strength manf from each api source.
Details on the requirements can be referred from the usfda guidance doc ANDAs: stability testing of drug substance and products question n. Answers. Section c: drug product manufacturing n packing Q.12
Regards.
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Sandesh Shetty
Apotex
Bangalore
India
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Original Message:
Sent: 8/6/2014 9:27:25 AM
From: mjgovani@gmail.com
Subject: Multiple API suppliers
Hello All,
Can we submit an ANDA submission with two API suppliers?. If yes, do we need to make 3 batches of each (API supplier) for stability data? Once the ANDA is approved, how can we switch between the suppliers. What kind of studies would be needed to show equivalency.
Appreciate your input on this.
Thanks,
Mehul
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Mehul Govani
Regulatory Specialist
United States
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