SEVELAMER-DRLA sevelamer carbonate 800 mg film-coated tablet bottle, Dr Reddy's Laboratories (Australia) Pty Ltd, CON-303
Product name
SEVELAMER-DRLA sevelamer carbonate 800 mg film-coated tablet bottle
Sponsor name
Dr Reddy's Laboratories (Australia) Pty Ltd
Consent start
Consent no.
CON-303
Standard
Subsection 11(b) of the Therapeutic Goods Order No. 78 Standard for Tablets and Capsules (TGO 78).
Non-compliance with standard
The products do not meet the assay limits of 92.5-107.5% for the stated content
of sevelamer carbonate.
Conditions imposed
The products conform to the agreed assay titratable amines limit using the
agreed assay titratable amines test.
The limits to be applied for the content of sevelamer carbonate must be
90.0-110.0 % of labelled claim.
Therapeutic product type
Prescription medicines