Updates on Bioequivalence Webpage

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Updates on Bioequivalence (BE) Webpage (November 2017): Immediate Release Solid Oral Dosage Form


1.    Additional Comparators Added to the Existing Comparator List



Active Ingredient

Additional Comparators




Apo-Trihex Tablet 2mg


Apotex Inc, Canada


2.    Additional Manufacturing Site added to Existing Comparator List



Active Ingredient

Comparator List

Product Name

Additional Manufacturing Site


Naltrexone Hydrochloride


Revia Tablet 50mg

Bristol-Myers Squibb Australia Pty Ltd., Australia

Teva Canada Limited, Canada


Drosperinone 3mg + Ethinylestradiol 0.02mg


Yaz Tablets

Bayer Weimar GmbH und Co. KG, Germany


3.    Active pharmaceutical ingredient added to “Other considerations (List C)

(i)    Destromethorphan HBr + Phenylephedrine HCl + Paracetamol

(ii)  Dextromethorphan HBr + Pseudoephedrine HCl + Paracetamol


Bioequivalence Webpage

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