Updates on Bioequivalence (BE) Webpage (March 2017): Immediate Release Solid Oral Dosage Form
- 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 |
- Additional Comparators Added to the Existing Comparator List
|
No |
Active Ingredient |
Additional Comparators |
Manufacturer |
|
1 |
Dothiepin |
Dothep 75mg Tablet (MAL19970063AZ)
|
Alphapharm Pty Ltd, Australia |
- 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 |
- 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
- Active pharmaceutical ingredient added to “Biowaivers granted based on unavailability/ inaccessibility of comparator/innovator product (List B)”
- Carbinoxamine Maleate + Pseudoephedrine Hydrochloride
