Updates on Bioequivalence (BE) Webpage (August 2016): Immediate Release Solid Oral Dosage Form

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Updates on Bioequivalence (BE) Webpage (August 2016): Immediate Release Solid Oral Dosage Form

 

1.New Active Ingredients Listed in the Product Comparator List

No

Active Ingredient

Comparators

Manufacturer

1

Eplerenone

Inspra 25mg Film-Coated Tablets

MAL20081801ARZ

 

Inspra 50mg Film-Coated Tablets

MAL20081802ARZ

 

Pfizer Pharmaceuticals LLC, United States

 

Pfizer Pharmaceuticals LLC, United States

2

Itopride Hydrochloride

Ganaton Tablet 50mg

MAL20051433AZ

 

Mylan EPD G.K., Japan

3

Mesna

Uromitexan Tablet 400mg

MAL20014208AZ

 

Uromitexan Tablet 600mg MAL20014209AZ

 

Temmler Pharma GmbH & Co KG, Germany

 

Temmler Pharma GmbH & Co KG, Germany

 

4

Pramipexole Dihydrochloride Monohydrate

Sifrol Tablet 0.125mg

MAL20000717AZ

 

Sifrol Tablet 0.25mg

MAL20000718AZ

 

Sifrol Tablet 1mg

MAL20000719AZ

 

Boehringer Ingelheim Pharma GmbH & Co. KG, West Germany

 

Boehringer Ingelheim Pharma GmbH & Co. KG, West Germany

 

Boehringer Ingelheim Pharma GmbH & Co. KG, West Germany

 

5

Rivaroxaban

Xarelto 20mg Film-Coated Tablet

MAL11115001AZ

 

Xarelto 15mg Film-Coated Tablet

MAL11115002AZ

 

Bayer Pharma AG, Germany

 

 

Bayer Pharma AG, Germany

 

6

Roflumilast

Daxas 500mcg Film-Coated Tablets

MAL20112164AZ

 

Takeda GmbH, Germany

7

Tretinoin

Vesanoid Soft-Gelatin Capsule 10mg

MAL19960996ACZ

Catalent Germany Eberbach GmbH, Germany

 

8

Levodopa + Carbidopa Monohydrate + Entacapone

Stalevo 75/18.75/200mg Film-coated Tablet

MAL11030095ACR

 

Stalevo 125/31.25/200mg Film-coated Tablet

MAL11030094ACR

 

 

Stalevo 200/50/200mg Film-coated Tablet

MAL09102942ACR

 

Stalevo 150/37.5/200mg Film-coated Tablets

MAL20051355AR

 

Stalevo 50/12.5/200mg Film-coated Tablets

MAL20051345AR

 

Stalevo 100/25/200mg Film-coated Tablets

MAL20051339AR

 

Orion Corp, Finland

 

 

 

Orion Corp, Finland

 

 

 

 

Orion Corp, Finland

 

 

Orion Corp, Finland

 

 

 

Orion Corp, Finland

 

 

 

Orion Corp, Finland

9

Telmisartan + Amlodipine Besilate

Twynsta Tablet 40/5mg

MAL20112135AC

 

Twynsta Tablet 40/5mg

MAL20112136AC

 

Twynsta Tablet 80/5mg

MAL20112137AC

 

Twynsta Tablet 80/10mg

MAL20112138AC

 

Cipla Limited, India

 

 

Cipla Limited, India

 

 

Cipla Limited, India

 

 

Cipla Limited, India

10

Rifampicin + Ethambutol HCl + Pyrazinamide + Isoniazide

Akurit-4 Tablet

MAL20051429AZ

Lupin Limited, India

12

Dutasteride + Tamsulosin HCl

Duodart 0.5mg/0.4mg Capsules

MAL20112150ACZ

 

Catalent Germany Schorndorf GmbH, Germany

  2.Additional Comparators Added to the Existing Comparator List

No

Active Ingredient

Comparator List

Additional Comparators

Manufacturer

1

Cimetidine

3

Apo-Cimetidine Tablet 200mg MAL19984721ARZ

 

Apo-Cimetidine Tablet 400mg MAL19984723ARZ

 

Apotex Inc., Canada

 

 

Apotex Inc., Canada

2

Meloxicam

6

Mobic Tablet 7.5 mg

MAL11060027ASZ

 

Boehringer Ingelheim Ellas A.E, Greece

3

Flutamide

7

FLUTA-cell 250mg Tablets MAL06021302ACZ

 

Rottendorf Pharma GmbH, Germany

4

Anagrelide

9

Agrylin 0.5mg Capsules MAL13055062ACRZ

DSM Pharmaceuticals, Inc., United States

5

Oxcarbazepine

-

Trileptal 300mg

MAL20021155ARZ

 

Novartis Farma S.P.A., Italy

 

6

Tadalafil

-

Cialis 2.5mg Film-Coated Tablets

MAL14125151AZ

 

Cialis 5mg Film-Coated Tablets

MAL14125149AZ

 

Lilly Del Caribe Inc., Puerto Rico

 

 

 

Lilly S.A., Spain

 

3.Additional Manufacturing Site added to Existing Comparator List

No

Active Ingredient

Comparator List

Product Name

Additional Manufacturing Site

1

Cyclosporin

1

Sandimmun Neoral 10mg Capsule

MAL20001791ARZ

 

Sandimmun Neoral Capsule 100mg MAL19962140ACRZ

 

Sandimmun Neoral Capsule 25mg

MAL19962142ACRZ

 

Catalent Germany Eberbach GmbH, Germany

 

2

Duloxetine

9

Cymbalta Capsule 30mg

MAL05092473AZ

 

Cymbalta Capsule 60mg

MAL05092474AZ

Lilly del Caribe Inc., Puerto Rico

 

 

Lilly del Caribe Inc., Puerto Rico

 

 

3

Ezetimibe

-

Ezetrol 10mg

MAL20034627AR

MSD International GmbH (Puerto Rico Branch) LLC, United States

 

4

Finasteride

-

Propecia Tablet

MAL19992040ACRZ

 

Proscar 5mg Tablet

MAL19985910ACRZ

 

Aiac International Pharma, LLC, United States

5

Imatinib mesylate

-

Glivec Tablet 100mg

MAL06011679AZ

 

Novartis Pharma Produktions GmbH, Germany

6

Isotretinoin

-

Roaccutane Capsule 20mg

MAL19991721ACZ

 

Roaccutane Capsule 10MG

MAL19991720ACZ

Catalent Germany Eberbach GmbH, Germany

 

Catalent Germany Eberbach GmbH, Germany

 

7

Moxifloxacin HCl

-

Avelox Tablet

MAL20012664A

 

Bayer Pharma AG, Germany

8

Isosorbide dinitrate

-

Isordil Oral Tablet 10mg

Interphil, Phillippines

9

Nystatin

-

Mycostatin Oral Tablet

 

Bristol Myers Squibb, Mexico

10

Tenoxicam

-

Tilcotil 20mg Tablet

 

Cenexi SAS, France

11

Cyproterone Acetate 2.0mg + Ethinyl Estradiol 0.035mg

FDC

Diane 35 Tablet

MAL19900568A

 

Bayer Weimar GmbH und Co. KG, Germany

 

12

Lamivudine 150mg + Zidovudine 300mg

FDC

Combivir Tablet

MAL19991350ARZ

GlaxoSmithKline Pharmaceuticals SA, Poland

 

 

13

Amiloride HCl + Hydrochlorothiazide

FDC

Moduretic Tablet

Aspen Port Elizabeth Pty Ltd, South Africa

 

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

•  Chloroquine Phosphate

•  L-tryptophan

 

5.Active pharmaceutical ingredients added to “Biowaivers List C ”

•  Orphenadrine citrate

 

 

 

 

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