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Updates on Bioequivalence Webpage

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

 

  1. New Active Ingredients Listed in the Product Comparator List

No

Active Ingredient

Comparators

Manufacturer

1

Dienogest

Visanne 2mg Tablet

MAL12105068ARZ

 

Bayer Weimar GmbH Co. Kg, Germany

2

Ivabradine Hydrochloride

 

Corolan 5mg Film-Coated Tablets

MAL20081755AZ

 

Corolan 7.5mg Film-Coated Tablets

MAL20081756AZ

 

Les Labs Servier Industrie, France

3

Rebamipide

Mucosta Tablets 100mg

MAL20071711ARZ

 

Korea Otsuka Pharmaceutical Co Ltd, South Korea

 

  1. Additional Comparators Added to the Existing Comparator List

No

Active Ingredient

Additional Comparators

Manufacturer

1

Trifluoperazine

Apo-Trifluoperazine 5mg

(MAL19984755AZ)

 

Apotex Inc, Canada

2

Ketoconazole

 

Ketozotan Tablet 200mg

(MAL19987372AZ)

 

Yucomy Tablet 200mg

(MAL19986498AZ)

 

Duopharma (M) Sdn. Bhd.

 

 

Y.S.P. Industries (M) Sdn. Bhd.

 

  1. Additional Manufacturing Site added to Existing Comparator List

No

Active Ingredient

Comparator List

Product Name

Additional Manufacturing Site

1

Spironolactone

BE

Aldactone Tablet 25mg

(1986030143A)

Piramal Healthcare UK Ltd, United Kingdom

 

2

Tadalafil

BE

Cialis 10mg Film Coated Tablet

(MAL20034164AZ)

 

Cialis 20mg Film Coated Tablet

(MAL20034166AZ)

 

Lilly Del Caribe Inc., Puerto Rico

3

 

Terbinafine Tablet

List 8

Lamisil 250mg Tablet

(MAL20000273ACRZ)

Novartis Pharma Produktions GmbH, Wehr, Germany

 

 

  

  1. Active pharmaceutical ingredient added to “Biowaivers granted based on unavailability/ inaccessibility of comparator/innovator product (List B)

 

  • Cycloserine

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