Are anyone claim 36 month expiry of Drug Product where drug substance have 30 month expiry

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Shikha Chauhan's picture

Answer: 
Yes,But with the justification, that the drug Product remains stable and data generated from the Accelerated and Long term studies during 36 months supports this.

Thanks and Regards, Shikha Chauhan http://www.pharmainfo.net/shikhachauhan/biography Lecturer (Pharmaceutics) Amity Institute of Pharmacy Amity University Noida Email: schauhan@amity.edu

Pushpendra Jain's picture

Answer: 
thnx shikha

Mind Hunter; Jiyo aur Jine do

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