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

 

No

Active Ingredient

Additional Comparators

Manufacturer

1

Benzhexol

Apo-Trihex Tablet 2mg

(MAL19984756AZ)

Apotex Inc, Canada

 

2.    Additional Manufacturing Site added to Existing Comparator List

 

No

Active Ingredient

Comparator List

Product Name

Additional Manufacturing Site

1

Naltrexone Hydrochloride

BE

Revia Tablet 50mg

Bristol-Myers Squibb Australia Pty Ltd., Australia

Teva Canada Limited, Canada

2

Drosperinone 3mg + Ethinylestradiol 0.02mg

FDC

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

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
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