Celecoxib Capsules 400mg Dissolution [Regulatives / Guidelines]
Dear All,
Request to confirm as per USFDA Dissolution data base Celecoxib Capsules 400mg,200mg,100mg,50mg need to perform Tier 1 & 2.
Our formulation meets in Tier 2 but not in Tier 1. USFDA can accept Tier 2 dissolution criteria for ANDA.
Due to 400mg for 75rpm & 200mg,100mg,50mg -50rpm.
Regards,
A.Anand.
Request to confirm as per USFDA Dissolution data base Celecoxib Capsules 400mg,200mg,100mg,50mg need to perform Tier 1 & 2.
Our formulation meets in Tier 2 but not in Tier 1. USFDA can accept Tier 2 dissolution criteria for ANDA.
Due to 400mg for 75rpm & 200mg,100mg,50mg -50rpm.
Regards,
A.Anand.
Complete thread:
- Celecoxib Capsules 400mg DissolutionAnand 2015-05-19 07:33 [Regulatives / Guidelines]