Dear all,
RLD Otic suspension product (nonsterile) having benzyl alcohol currently in Glass bottle, screw cap and with dropper. With ANDA application change to PLASTIC HDPE/LDPE Dropper bottle - what data package is required for US.
- Sterilisation cycle optimization & validation - no phase separation
- Leachables/extractables
- Drug product stability - minimum 6 months long term/accelerated, assuming highly stable, would enable maintaining current shelf-life of 24 months at a push with extra data provision during review.
Do we need to present in the pre-ANDA meeting?
Regards,
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sapna rathi
Regulatory specialist
AHME
India
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