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Updates on Bioequivalence (BE) Webpage

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

 

  1. New Active Ingredients Listed in the Product Comparator List

No

Active Ingredient

Comparators

Manufacturer

1

Crizotinib

Xalkori 200mg Hard Capsules

MAL12095102AZ

 

Pfizer Manufacturing Deutschland GmbH, Germany

2

Daclatasvir dihydrochloride

Daklinza 30mg Film-coated Tablets

MAL16045046ACRZ

 

Daklinza 60mg Film-coated Tablets

MAL16045037ACRZ

 

AstraZeneca Pharmaceuticals LP, United States

3

Dydrogesterone

Duphaston Tablet 10mg

MAL19920643AZ

 

Abbott Biologicals B.V., Netherlands

4

Febuxostat

Feburic 80mg Film-coated Tablets

MAL16075031ACRZ

 

Pantheon France, France

5

Fingolimod hydrochloride

Gilenya 0.5mg Hard Capsule

MAL12015017ARZ

 

Novartis Pharma Stein Ag, Switzerland

6

Lacosamide

Vimpat 50mg Film-coated Tablets

MAL12055002AZ

 

Vimpat 100mg Film-coated Tablets

MAL12055008AZ

 

Vimpat 150mg Film-coated Tablets

MAL12055009AZ

 

Vimpat 200mg Film-coated Tablets

MAL12055010AZ

 

Aesica Pharmaceuticals GmbH, Germany

7

Lapatinib ditosylate

Tykerb Film-coated Tablets 250mg

MAL20071677ACRZ

 

Glaxo Operations UK Ltd, United Kingdom

8

Linagliptin

Trajenta 5mg Film-coated Tablets

MAL12045094ACZ

 

Boehringer Ingelheim Roxane, Inc, United States

9

Nilotinib hydrochloride monohydrate

Tasigna 150mg Capsule

MAL11105040ARZ

 

Novartis Pharma Stein Ag, Switzerland

10

Pazopanib Hydrochloride

Votrient Film-coated Tablet 200mg

MAL20102071ACRZ

 

Votrient Film-coated Tablet 400mg

MAL20102072ACRZ

Glaxo Operations UK Ltd, United Kingdom

 

 

11

Pinaverium bromide

Dicetel 50mg Film-coated Tablet

MAL12045092AZ

 

Dicetel 100mg Film-coated Tablet

MAL20122215AZ

 

Abbott Healthcare SAS, France

 

 

Mylan Laboratories SAS, France

12

Prucalopride succinate

Resolor 1mg Film Coated Tablets

MAL12025075AZ

 

Resolor 2mg Film Coated Tablets

MAL12025076AZ

 

Janssen Cilag SPA, Italy

 

 

 

13

Sitagliptin

Januvia 25mg Tablet

MAL20071662ARZ

 

Januvia 50mg Tablet

MAL20071663ARZ

 

Januvia 100mg Tablet

MAL20071664ARZ

 

Merck Sharp & Dohme Ltd, United Kingdom

14

Sofosbuvir

Sovaldi 400mg Film-coated Tablets

MAL15095034AZ

 

Gilead Sciences Ireland UC, Ireland

15

Sunitinib Malate

Sutent 12.5mg Capsule

MAL20071632AZ

 

Sutent 25mg Capsule

MAL20071633AZ

 

Sutent 50mg Capsule

MAL20071634AZ

 

Pfizer Italia S.R.L., Italy

 

16

Telbivudine

Sebivo 600mg Tablets

MAL20071671ARZ

 

Novartis Pharma Stein Ag, Switzerland

17

Ulipristal Acetate

Ella Tablet 30mg

MAL12035079ACZ

 

Cenexi, France

18

Valganciclovir

Valcyte Tablets 450mg

MAL20040021ARZ

 

Patheon Inc, Canada

19

Ledipasvir + Sofosbuvir

HARVONI (Ledipasvir 90mg/Sofosbuvir 400mg) Film-coated Tablets

MAL16035013AZ

 

Gilead Sciences Ireland UC, Ireland

20

Drospirenone 2mg + Estradiol Hemihydrate 1mg

Angeliq Tablet

MAL20061594ARZ

 

Bayer Weimar GmbH und Co . KG, Germany

21

Amlodipine Camsylate +

Losartan Potassium

Cozaar XQ 5/100mg Tablet

MAL12025078ACRZ

 

Cozaar XQ 5/50 mg Tablet

MAL12025077ACRZ

 

Hanmi Pharm. Co., Ltd. (Paltan Site), South Korea

22

Artesunate + Mefloquine HCl

Artesunate and Mefloquine Hydrochloride Tablets 100/220mg

MAL12035082AZ

 

Artesunate and Mefloquine Hydrochloride Tablets 25/55 mg

MAL12035081AZ

 

Cipla Ltd, India

20

Tegafur +

Gimeracil +

Oteracil Potassium

TS-ONE Capsule 20

MAL12075066ARZ

 

TS-ONE Capsule 25

MAL12075067ARZ

 

Taiho Pharmaceutical Co. Ltd., Japan

21

Estradiol Valerate +

Norgestrel

Progyluton Tablets

MAL20021014AZ

 

Bayer Weimar GmbH und Co. KG, Germany

 

  1. Additional Comparators Added to the Existing Comparator List

No

Active Ingredient

Additional Comparators

Manufacturer

1

Dothiepin

Dothep 75mg Tablet

(MAL19970063AZ)

 

Alphapharm Pty Ltd, Australia

 

  1. Additional Manufacturing Site added to Existing Comparator List

No

Active Ingredient

Comparator List

Product Name

Additional Manufacturing Site

1

Pseudoephedrine HCl  +

Triprolidine HCl

 

FDC

Actifed Tablet

Glaxo Wellcome GmbH & Co., Bad Oldesloe, Germany

 

  1. Active pharmaceutical ingredient changed from “Biopharmaceutics Classification System (BCS)- Based Biowaiver (List A)” to “Biowaivers granted based on unavailability/ inaccessibility of comparator/innovator product (List B)

 

  • Quinine sulfate

 

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

 

  • Carbinoxamine Maleate + Pseudoephedrine Hydrochloride

 

 

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