Anand
☆    

India,
2015-05-19 09:33
(3262 d 05:03 ago)

Posting: # 14852
Views: 2,508
 

 Celecoxib Capsules 400mg Dissolution [Regulatives / Guidelines]

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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.
 
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