List of Comparator Products for Bioequivalence Studies11062013 V1

LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES

(JUNE 2013)

Bil.

TEST PRODUCTS

(Pharmaceutical

name)

Comparator Products

Trade Mark/Registration No./

Reference No. Manufacturer

1. Acarbose GLUCOBAY TABLET 50MG MAL19940745A

GLUCOBAY TABLET 100MG

MAL19940746A

BAYER SCHERING

PHARMA AG,

LEVERKUSEN, GERMANY

2. Acebutolol hydrochloride

SECTRAL CAPSULE 100MG

(MAL19870251A)

SECTRAL CAPSULE 200MG

(MAL19870052A)

SECTRAL TABLET 400MG

(MAL19870053A)

MAY & BAKER LTD, MAY

& BAKER LTD,

DAGENHAM, ESSEX,

RM107XS, ENGLAND

SECTRAL 200MG CAPSULE

MAL19920620A

RHONE-POULENC RORER,

JL LAWANG GINTUNG,

BOGUR, WEST JAVA,

INDONESIA

3. Acemetacin RANTUDIL CAPSULE 60MG (MAL19986936A)

BAYER AG, WEST

GERMANY

RANTUDIL RETARD 90MG

CAPSULE

(MAL19992054A)

BAYER SCHERING

PHARMA AG, GERMANY

4. Acetazolamide DIAMOX TABLET 250MG

AMERICAN CYANAMID

CO.,US

DIAMOX TABLET 250MG

LEDERLE LABS DIV

CYANAMID, UNITED

KINGDOM

5. Acipimox OLBETAM CAPSULE 250 MG (MAL19900589A)

PHARMACIA S.P.A, ITALY

6. Acitretin NEOTIGASON CAPSULE 10 MG (MAL06091392AC)

NEOTIGASON CAPSULE 25 MG

(MAL06091393AC)

PATHEON INC, CANADA

NEOTIGASON HARD GELATIN

CAPSULE 10MG

(MAL19921411A)

NEOTIGASON HARD GELATIN

CAPSULE 25*

(MAL19921412A)

ROCHE PRODUCTS LTD,

UNITED KINGDOM

7. Acrivastine SEMPREX CAPSULE 8MG (MAL19900013A)

SMITHKLINE BEECHAM

PHARM, UNITED

KINGDOM


(JUNE 2013)

Bil.

TEST PRODUCTS

(Pharmaceutical

name)

Comparator Products



8. Adefovir HEPSERA TABLET 10MG MAL20040907A

GLAXOSMITHKLINE

(TIANJIN) CO. LTD.,

CHINA

9. Allopurinol ZYLORIC 100MG TABLETS MAL19973571AS

ZYLORIC TABLET 300MG

MAL19972499AS

ASPEN PORT ELIZABETH

(PTY) LTD

CNRS FAIRCLOUGH

ROAD AND GIBAUD

ROAD, KORSTEN PORT

ELIZABETH, 6020

REPUBLIC OF SOUTH

ARICA , SOUTH AFRICA.

10. Allyoestrenol GESTANIN TABLET 5MG MAL19870680A

ORGANON LABS LTD,

SCOTTLAND

11. Alverin citrate SPASMAVERINE TABLET 0.04G MAL19871806A

LABORATOIR BELLON,

FRANCE

12. Amantadine hydrochloride

SYMMETREL SOFT GELATIN

CAPSULE 100*

1986040644A

NOVARTIS PHARMA

STEIN AG, SWITZERLAND

13. Amantadine sulphate PK-MERZ TABLET 100MG MAL19860850A

MERZ PHARMA GMBH &

CO. KGAA,GERMANY

14. Amiodarone hydrochloride

CORDARONE 200MG

MAL19987968AR

SANOFI WINTHROP

INDUSTRIE, FRANCE

15. Amisulpride SOLIAN 100MG SCORED TABLET MAL20032239A

SOLIAN 400MG SCORED FILM-

COATED TABLET

MAL20032240A

SANOFI WINTHROP

INDUSTRIE, FRANCE

16. Amodiaquine CAMOQUIN PFIZER, UNITED KINGDOM

17. Anastrozole ARIMIDEX TABLET 1MG MAL19987960AR

ASTRAZENECA

PHARMACEUTICALS LP,

UNITED STATES

18. Aprepitant EMEND 80MG CAPSULE MAL20040905AR

EMEND 125MG CAPSULE

MAL20040906AR

MERCK SHARP & DOHME

CORP.*, UNITED STATES

19. Atomoxetine STRATTERA 60MG CAPSULE MAL20051406A

STRATTERA 40MG CAPSULES

MAL20051405A


LILLY S.A, MADRID,

SPAIN


(JUNE 2013)

Bil.

TEST PRODUCTS

(Pharmaceutical

name)

Comparator Products



MAL20051004A


MAL20051403A


MAL20051402A

20. Baclofen LIORESAL 10MG TABLET MAL20000748AC

NOVARTIS FARMA S.P.A.,

ITALY

21. Bacampicillin As agreed upon in Mesyuarat Jawatankuasa Kerja Bioekuivalens Kebangsaan 1/2012 13 September 2012, the following requirement to be submitted in place of bioequivalence report :-

i) Validation process report for 3 consecutive batches ii) Comparative dissolution profile for 3 consecutive batches (time

points : 0, 5, 15, 30 & 45 minutes )

22. Benfluorex MEDIAXAL TABLET 150MG MAL19870176A

LES LABS SERVIER

INDUSTRIE, FRANCE

23. Benzhexol ARTANE TABLET 2MG PBKD861498A

ARTANE TABLET 2MG

PBKD861497A

AMERICAN CYANAMID

CO, UNITED STATES

CYANAMID OF GREAT

BRITAIN, UNITED

KINGDOM

This product can be obtained from Nagoya, Japan (Information

updated from Pfizer on 25th

January 2013 via a letter)

24. Benztropine mesylate COGENTIN TABLET 2MG MAL19870343AR

MERCK SHARP & DOHME

INT, UNITED STATES

25. Betahistine dihydrochloride

BETASERC 24MG TABLET

MAL07061394A

BETASERC 16MG TABLETS

MAL19972468A

ABBOTT HEALTHCARE

SAS, FRANCE

26. Betahistine mesylate MERISLON TABLET 6MG MAL19861236A

EISAI CO LTD, JAPAN

27. Betamethasone

BETNELAN TABLET 0.5MG,

MAL19870589A

GLAXO WELLCOME

OPERATIONS UNITED

KINGDOM

As agreed upon in Mesyuarat Jawatankuasa Kerja Bioekuivalens Kebangsaan 1/2013 13 March 2013, the following requirement to be submitted in place of bioequivalence report :-

i) Validation process report for 3 consecutive batches ii) Comparative dissolution profile for 3 consecutive batches

(time points : 0, 5, 15, 30 & 45 minutes )


(JUNE 2013)

Bil.

TEST PRODUCTS

(Pharmaceutical

name)

Comparator Products



28. Betaxolol KERLONE TABLET 20MG MAL19872264A

SANOFI WINTHROP

INDUSTRIE, FRANCE

29. Bezafibrate BEZALIP COATED TABLET 200MG 1993010002A

ROCHE DIAGNOSTICS

GMBH, GERMANY

30. Bicalutamide CASODEX TABLET 50MG MAL19990958ACR

CASODEX 150MG TABLET

MAL20040082AR

CORDEN PHARMA GMBH,

GERMANY.

ASTRAZENECA GMBH ,

GERMANY

31. Bisoprolol fumarate CONCOR 2.5MG TABLET MAL20020792A

CONCOR 5 FILM COATED TABLET

MAL19890389A

CONCOR 10 FILM-COATED

TABLET

MAL19890390A

MERCK KGAA, GERMANY

32. Bosentan monohydrate

TRACLEER TABLET 62.5 MG

MAL20041084ACR

TRACLEER TABLET 125 MG

MAL20041085ACR

PATHEON INC., CANADA

33. Brompheniramine maleate

DIMETANE TABLET 4MG

1986041234A

A.H.ROBINS PTY LTD,

AUSTRALIA

34. Buclizine hydrochloride

LONGIFENE TABLET 25MG

MAL19861193A

UCB S.A. SECTOR

PHARMA,

BELGIUM

35. Bumetanide BURINEX TABLET 1MG MAL19913216A

LEO PHARM PRODUCTS,

DENMARK

36. Busulphan MYLERAN TABLETS 2MG MAL05051050AC

EXCELLA GMBH,

GERMANY

37. Butropium bromide COLIOPAN TABLET 5MG MAL19910111A

EISAI TAIWAN INC,

TAIWAN

38. Cabergoline DOSTINEX TABLET 0.5MG MAL19971775A

PFIZER ITALIA S.R.L.,

ITALY

39. Candesartan Cilexetil Tablet

ATACAND TABLET 16MG

MAL2001219AR

ATACAND TABLET 4MG

MAL20001217A

ATACAND TABLET 32MG

MAL09042471A

ASTRAZENECA AB,

SWEDEN

ASTRAZENECA AB,

SWEDEN

ASTRAZENECA AB,

SWEDEN

40. Capecitabine XELODA TABLET 150MG MAL20000001A

XELODA TABLET 500MG

MAL20000002A

PRODUCTOS ROCHE S.A

DE C.V, MEXICO


(JUNE 2013)

Bil.

TEST PRODUCTS

(Pharmaceutical

name)

Comparator Products



41. Carbimazole NEOMERCAZOLE TABLET 5 MG MAL05092230AC

APTUIT (EDINBURGH)

LIMITED, UNITED

KINGDOM

42. Cefaclor DISTACLOR CAPSULE 250MG MAL19962114A

DISTACLOR CAPSULE 500MG

MAL19962115A

ELI LILLY &C0 (TAIWAN)

INC, TAIWAN

43. Cefadroxil monohydrate

DURICEF CAPSULE 500MG

MAL19860523A

DURICEF TABLET 1GM

MAL19940665A

BRISTOL-M

BARCELONETA INC,

PUERTO RISO, UNITED

STATES

44. Cefdinir OMNICEF CAPSULE 100MG MAL19991688AC

UPHA PHARMACEUTICAL

MFG. (M) SDN BHD,

MALAYSIA

45. Cefprozil PROCEF TABLET 250MG MAL19940487A

PROCEF TABLET 500MG

MAL19940483A

BRISTOL-M

BARCELONETA INC,

UNITED STATES

46. Ceftibuten CEDAX CAPSULE 200MG MAL19950228A

CEDAX CAPSULE 400MG

MAL19950227A

SIFI S.P.A., ITALY

47. Celecoxib CELEBREX CAPSULE 100MG MAL20000004AR

CELEBREX CAPSULE 200MG

MAL20000005AR

CELEBREX 400MG CAPSULES

MAL08051748AR

PFIZER

PHARMACEUTICAL LLC,

PUERTO RICO

48. Cephradine VELOSEF CAPSULE 500MG MAL19920468A

BRISTOL-MYERS SQUIBB

AEBE, GREECE

49. Chloroquine NIVAQUINE TABLET 200MG MAL19912313A

MAY & BAKER LTD,

UNITED KINGDOM

50. Chlorothiazide CHLOTRIDE TABLET 500MG REF.NO1986040263A

MERCK SHARP & DOHME

INT, UNITED STATES

51. Chlorpheniramine maleate

PIRITON TABLET 4MG

MAL07082871AC

HAUPT PHARMA

WULFING GMBH,

GERMANY

52. Chlorpropamide DIABENESE TABLET 250MG MAL19986461A

PFIZER AUSTRALIA PTY.

LTD., AUSTRALIA

DIABINESE TABLET 250MG

MAL19870382A

PFIZER PHARM DIV.,

PHILIPINES


(JUNE 2013)

Bil.

TEST PRODUCTS

(Pharmaceutical

name)

Comparator Products



53. Chlortetracycline AUREOMYCIN CAPSULE 250MG MAL19871950A

INTERTHAI

PHARMACEUTICAL

MANUFACTURING LTD,

THAILAND

54. Chlorthalidone HYGROTON TABLET 25MG PBKD870184A

HYGROTON TABLET 50MG

PBKD870185A

NOVARTIS PHARMA


55. Chlorzoxazone SOLAXIN TABLET 200MG PBKD861510A

EISAI CO. LTD, JAPAN

As agreed upon in Mesyuarat Jawatankuasa Kerja Bioekuivalens Kebangsaan 1/2013 13 March 2013, the following requirement to be submitted in place of bioequivalence report :-

iii) Validation process report for 3 consecutive batches iv) Comparative dissolution profile for 3 consecutive batches


56. Cilostazol PLETAAL 50MG TABLETS MAL20061476A

PLETAAL 100MG TABLETS

MAL20061475A

KOREA OTSUKA

PHARMACEUTICAL CO

LTD, KOREA

57. Cinnarizine STUGERON 25MG TABLET MAL19871481A

JANSSEN CILAG SPA,

ITALY

58. Clemastine fumarate TAVEGYL TABLET 1MG PBKD861195A

NOVARTIS PHARMA AG,

SWITZERLAND

59. Clenbuterol hydrochloride

SPIROPENT TABLET 0.01MG

MAL19870785A

BOEHRINGER INGELHEIM

INTERNATIONAL GMBH,

GERMANY

60. Clodronate OSTAC CAPSULE 1989120003A

ROCHE DIAGNOSTICS

GMBH, GERMANY

61. Clomiphene CLOMID TABLET 50MG MAL19950686A

PATHEON FRANCE S.A.,

FRANCE

62. Clonazepam RIVOTRIL ROCHE TABLET 0.5MG MAL19860961A

ROCHE FARMA S.A.,

SPAIN

RIVOTRIL ROCHE TABLET 2MG

MAL19860962A

63. Clonidine DIXARIT TABLET 25MCG MAL19870080A


INTERNATIONAL GMBH,

GERMANY.

DIXARIT SUGAR-COATED

TABLET 0.025MG


FRANCE, FRANCE.


(JUNE 2013)

Bil.

TEST PRODUCTS

(Pharmaceutical

name)

Comparator Products



MAL19986979A

CATAPRES TABLET 0.15MG

MAL19861621A


LTD, SOUTH KOREA

64. Clorazepate dipotassium

TRANXENE CAPSULE 5MG

PBKD861331AR

TRANXENE CAPSULE 10MG

PBKD861332AR

SANOFI WINTHROP

INDUSTRIE, FRANCE

65. Cyproterone acetate ANDROCUR 50MG TABLET MAL19993023AR

DELPHARM LILLE S.A.S.,

FRANCE

66. Danazol LADOGAL CAPSULE 50MG PBKD870433A

LADOGAL CAPSULE 100MG

PBKD870434A

LADOGAL CAPSULE 200MG

PBKD870435A

NYCOMED PUERTO RICO

INC, PUERTO RICE

NYCOMED PUERTO RICO

INC, PUERTO RICE

NYCOMED PUERTO RICO

INC, PUERTO RICE

Product is available in Taiwan & Philliphines

(Information obtained via an email from Sanofi Aventis (M) Sdn. Bhd

dated 22 May 2013)

67. Dapsone AVLOSULFON TABLET 0.1G 1986043833A

ASTRAZENECA UK

LIMITED, UNITED

KINGDOM

68. Dasatinib SPRYCEL 20MG TABLET MAL20071695AR

SPRYCEL 50MG TABLET

MAL20071696AR

SPRYCEL 70MG TABLET

MAL20071697AR


COMPANY, UNITED

STATES

69. Deferiprone

FERRIPROX 500MG TABLET

MAL20033480AC

APOTEX INC CANADA

70. Desloratadine AERIUS TABLET MAL20020876AR

SCHERING PLOUGH SPA,

ITALY

AERIUS TABLET 5MG

MAL10053655AS

SCHERING-PLOUGH

LABO N.V., BELGIUM

71. Dexchlorpheniramine maleate

POLARAMINE 2MG TABLET

MAL09072776A

SCHERING-PLOUGH

LABO N.V., BELGIUM

72. Dexketoprofen trometamol

KETESSE 25MG FILM COATED

TABLET

MAL20061602A

A. MENARINI

MANUFACTURING

LOGISTIES AND

SERVICES S.R.L, ITALY

73. Diacerein ARTRODAR MAL20041211A

TRB PHARMA S.A,

ARGENTINA


(JUNE 2013)

Bil.

TEST PRODUCTS

(Pharmaceutical

name)

Comparator Products



74. Diclofenac potassium VOLTAREN DOLO 12.5 MG FILM-COATED TABLETS

MAL06071043A

NOVARTIS

FARMACEUTICA S.A.,

SPAIN

CATAFLAM 25MG TABLETS

MAL19960970A


ITALY

CATAFLAM TABLET 50MG

MAL19960971A

NOVARTIS SAGLIK,

TURKEY

75. Diclofenac sodium VOLTAREN TABLET 25MG MAL19861069A

VOLTAREN TABLET 50MG

MAL19861068A

NOVARTIS SAGLIK,

TURKEY

76. Diflunisal DOLOBID TABLET 250MG MAL19861106AR

DOLOBID TABLET 500MG

MAL19890178AR

MERCK SHARP & DOHME

INT, UNITED STATES

77. Dihydroergotamine mesylate

SEGLOR CAPSULE 5MG

MAL19870274A

SANOFI WINTHROP

INDUSTRIE, FRANCE

78. Dimenhydrinate DRAMAMINE TABLET 50MG MAL19870328A

PROQUALIX PTY LTD,

AUSTRALIA

Product is available in Costa Rica, Dominican Republic, El Salvador,

Guatemala, Honduras, Mexico, Nicarague, Panama, Colombia,

Peru and Chile.

(Information obtained via an email from Johnson & Johnson Malaysia

dated 27th

Sept 2012)

79. Diphenidol hydrochloride

CEPHADOL TABLET 25MG

MAL19861237A

NIPPON SHINYAKU CO

LTD, JAPAN

80. Dipyridamole PERSANTIN TABLET 75MG MAL19870161A


INTERNATIONAL GMBH,

GERMANY

81. Domperidone MOTILIUM TABLET 10MG MAL19872254AR

JANSSEN CILAG, FRANCE

82. Donepezil ARICEPT F.C. 5MG MAL20013565A

ARICEPT TABLET 10MG

MAL05020190AC

EISAI TAIWAN INC,

TAIWAN

83. Doxazosin CARDURA TABLET 2MG MAL19990562AS


LTD., AUSTRALIA

84. Dronedarone Hydrochloride

MULTAQ 400MG FILM-COATED

TABLETS

MAL20102016A

SANOFI WINTHROP

INDUSTRIE, FRANCE

85. Drotaverine NO-SPA TABLETS 40MG MAL19900596A

CHINOIN

PHARMACEUTICAL &


(JUNE 2013)

Bil.

TEST PRODUCTS

(Pharmaceutical

name)

Comparator Products



NO-SPA FORTE TABLET

MAL20001801A

CHEMICAL WORKS

PRIVATE CO LTD,

HUNGARY

Product is available in Mexico, Vietnam, China & Pakistan

(Information obtained via an email from Sanofi Malaysia dated 8th

March 2013)

86. Dutasteride AVODART SOFT GELATIN CAPSULES

MAL20040194AR

RP SCHERER SA, FRANCE

87. Eletriptan hydrobromide

RELPAX 20MG TABLET

MAL20021359A

RELPAX 40MG TABLET

MAL20021360A

RELPAX 80MG TABLET

MAL20021361A


LTD., AUSTRALIA

88. Entacapone COMTAN TABLET 200MG MAL19992996A

ORION CORP, FINLAND

89. Entecavir BARACLUDE TABLET 0.5 MG MAL20061502AR


COMPANY, UNITED

STATES

90. Eperisone hydrochloride

MYONAL TABLET 50MG

MAL19940448A

MISATO PLANT OF EISAI

CO, JAPAN

91. Esomeprazole magnesium

NEXIUM 20MG TABLET

MAL20020238AR

NEXIUM 40MG TABLET

MAL20020239AR

ASTRAZENECA AB,

SWEDEN

92. Estradiol PROGYNOVA 1MG TABLET MAL09020971AC

PROGYNOVA TABLET 2MG

MAL09020972AC

DELPHARM LILLE S.A.S.,

FRANCE

93. Estramustine sodium phosphate

ESTRACYT CAPSULE 140MG

MAL19990993A


ITALY

94. Etoricoxib ARCOXIA 60MG TABLET MAL20034170AR

ARCOXIA 90MG TABLET

MAL20034179AR

ARCOXIA 120MG TABLET

MAL20034182AR

MERCK & CO INC,

UNITED STATES

95. Exemestane AROMASIN TABLET 25MG MAL08111847A

AROMASIN 25MG TABLETS

MAL20013341A


ITALY


(JUNE 2013)

Bil.

TEST PRODUCTS

(Pharmaceutical

name)

Comparator Products



96. Ezetimibe EZETROL 10MG MAL20034627AR

SCHERING PLOUGH

PRODUCTS, UNITED

STATES

97. Famciclovir FAMVIR TILTAB TABLET 250MG MAL19950237A

NOVARTIS

FARMACEUTICA S.A.,

SPAIN

98. Famotidine PEPCIDINE 20MG TABLET MAL19900506A

MERCK SHARP & DOHME

(AUSTRALIA) PTY LTD,

AUSTRALIA

99. Fenofibrate LIPANTHYL SUPRA 160MGFILM-COATED TABLET

MAL20020488A

LIPANTHYL PENTA 145 FILM

COATED TABLET

MAL10053648A

RECIPHARM FONTAINE,

FRANCE

LIPANTHYL MICRO CAPSULE

MAL19983968A

LIPANTHYL MICRO 267 CAPSULE

MAL20014486A

LABS FOURNIER SA,

FRANCE

Product is available in Indonesia, Philippines, Singapore,

Switzerland, Thailand & Vietnam

(Information obtained via an email from Abbott Malaysia dated 12 April

2013)

100. Fexofenadine hydrochloride

TELFAST 30MG TABLET

MAL20031923A

TELFAST 60MG TABLET

MAL20051395AR

AVENTIS PHARMA INC,

UNITED STATES

TELFAST 120MG

MAL20000714A

HOECHST MARION

ROUSSEL INC, UNITED

STATES

TELFAST 180MG TABLET

MAL20000715A

SANOFI-AVENTIS U.S.

LLC, UNITED STATES

101. Finasteride PROPECIA TABLET MAL19992040AR

PROSCAR 5MG TABLET

MAL19985910AR

MERCK SHARP & DOHME

QUIMICA DE PUERTO

RICO LTD, UNITED

STATES

102. Flavoxate URISPAS 200 TABLET MAL20033669A

RECORDATI INDUSTRIA

CHIMICA E

FARMACEUTICA S.P.A.,

ITALY

103. Flecainide TAMBOCOR TABLET 100MG MAL19871528AR

3M HEALTHCARE LTD,

UNITED KINGDOM


(JUNE 2013)

Bil.

TEST PRODUCTS

(Pharmaceutical

name)

Comparator Products



104. Flucloxacillin STAPHLEX 250 CAPSULE MAL19940106A

STAPHLEX 500 CAPSULE

MAL19940107A

PACIFIC PHARM LTD,

NEW ZEALAND

PACIFIC PHARM LTD,

NEW ZEALAND

105. Fludarabine FLUDARA 10MG FILM COATED TABLETS

MAL05051075AC

BAYER SCHERING

PHARMA AG, GERMANY

106. Fludrocortisone acetate

FLORINEF 0.1MG TABLET

MAL19990027A


PTY LTD, AUSTRALIA

107. Flunarizine hydrochloride

SIBELIUM CAPSULE 5MG

MAL19880179AR

SIBELIUM TABLET 5 MG

MAL09100238A

JANSSEN-CILAG S.P.A.,

ITALY

108. Fluoxymesterone HALOTESTIN TABLETS 5MG (BELGIUM)

MAL19920022A

PHARMACIA & UPJOHN

S.A., BELGIUM

109. Flupentixol dihydrochloride

FLUANXOL TABLET 0.5MG

MAL19890543A

FLUANXOL TABLETS 3MG

MAL19980544A

FLUANXOL TABLETS 1MG

MAL19900451A

H.LUNDBECK A/S,

DENMARK

110. Flurazepam Monohydrochloride

DALMADORM 15MG CAPSULES

MAL07050892AC

LABIANA

PHARMACEUTICALS SL,

SPAIN

111. Flurbiprofen FROBEN TABLET 50MG MAL19861117A

THE BOOTS COMPANY

PLC, UNITED KINGDOM

112. Fosinopril sodium MONOPRIL TABLET 10MG MAL19992695AS

PT BRISTOL-MYERS

SQUIBB INDONESIA TBK

MONOPRIL TABLET 10MG

MAL19950242A

MONOPRIL TABLET 20MG

MAL19950243A


PTY LTD, AUSTRALIA

113. Gabapentin NEURONTIN 100MG CAPSULE MAL06071076A

NEURONTIN 300MG CAPSULE

MAL19984786AS


MAL19984785AS

PFIZER

MANUFACTURING

DEUTSCHLAND GMBH,

GERMANY


MAL19962169A


PFIZER

PHARMACEUTICALS LLC,

UNITED STATES


(JUNE 2013)

Bil.

TEST PRODUCTS

(Pharmaceutical

name)

Comparator Products



MAL19962170A

NEURONTIN TABLET 600MG

MAL20031747A

NEURONTIN TABLET 800MG

MAL20031748A

114. Galantamine hydrobromide

REMINYL TABLET 4MG

MAL20020123A

REMINYL TABLET 8MG

MAL20020124A

REMINYL TABLET 12MG

MAL20020125A

JANSSEN CILAG SPA,

ITALY

115. Ganciclovir CYMEVENE CAPSULE 250MG MAL19993019AR

ROCHE PRODUCTS LTD,

UNITED KINGDOM

CYMEVENE HARD-GELATIN

CAPSULE 250MG

MAL19970079A

SYNTEX PUERTO RICO

INC, UNITED STATES

116. Gemfibrozil LOPID CAPSULE 300MG MAL19990998A

LOPID 600MG TABLET

MAL19900442AR

LOPID 600MG TABLET

MAL19984784AS

PARKE DAVIS PTY LTD,

AUSTRALIA

LOPID 450MG TABLET

MAL19921617ARS

GOEDECKE A.G, WEST

GERMANY

Products are available in Argentina, Australia, Austria, Brazil,

Switzerland, Chile, Germany, Denmark, Spain, France, United

Kingdom, Greece, Hong Kong, Indonesia, India, Ireland, Italy,

Mexico, Netherlands, Norway, Peru, Portugal, Philippines, Sweden,

Thailand, Turkey, Taiwan, United States

117. Gestrinone DIMETRIOSE CAPSULE MAL19940494A

ROUSSEL LABS LTD,

UNITED KINGDOM

118. Glipizide MINIDIAB 5MG TABLET MAL19913361A


ITALY

119. Granisetron hydrochloride

KYTRIL TABLET 1MG

MAL19940574A

F.HOFFMANN-LA ROCHE

LTD, SWITZERLAND

120. Hyoscine butylbromide

BUSCOPAN TABLET 10MG

MAL09051577A

DELPHARM REIMS,

FRANCE

121. Hydroxycarbamide HYDREA CAPSULE 500MG, MAL19962497A

HYDREA CAPSULE 500MG,

MAL19993027A

BRISTOL MYERS SQUIBB

US


S.R.L, ITALY


(JUNE 2013)

Bil.

TEST PRODUCTS

(Pharmaceutical

name)

Comparator Products



122. Hydroxyurea/ Hydroxycarbamide


MAL19962497A


MAL19993027A


US


S.R.L, ITALY

123. Hydrochlorothiazide DICHLOTRIDE TABLET 25MG, MAL19870271AR DICHLOTRIDE

TABLET 50MG, MAL19870201AR

MERCK SHARP & DOHME

UNITED KINGDOM

DICHLOTRIDE 25MG TABLET,

MAL19940018AS DICHLOTRIDE

50MG TABLET, MAL19940019AS

MERCK SHARP & DOHME


AUSTRALIA

124. Hydrocortisone CORTEF TABLET 10MG CATALENT PHILADELPHIA

Product is available in Bosnia, Canada, Georgia, Croatia, Hungary,

Poland, Russia, Saudi Arabia, Thailand, Tunisia, United States.

(Information obtained from Pfizer via a letter dated 25/1/2013)

125. Ibandronic acid BONDRONAT FILM-COATED TABLET 50 MG

MAL20071698A

BONVIVA FILM-COATED

TABLETS 150 MG

MAL20071629A

F.HOFFMANN-LA ROCHE

LTD, SWITZERLAND

126. Imatinib mesylate GLIVEC 50MG CAPSULES MAL20020355A

GLIVEC 100MG CAPSULES

MAL20020356A

GLIVEC TABLET 100MG

MAL06011679A

GLIVEC TABLET 400MG

MAL06011681A

NOVARTIS PHARMA


127. Imidapril hydrochloride

TANATRIL 2.5MG TABLET

MAL20034616A

TANATRIL 5MG TABLET

MAL20034617A

TANATRIL 10MG TABLET

MAL20034618A

PT TANABE INDONESIA,

INDONESIA

128. Indapamide NATRILIX TABLET MAL19972491A

NATRILIX TABLET 0.0025G

MAL19870270AR

LES LABS SERVIER

INDUSTRIE, FRANCE

Product is available in Australia, Bangladesh, China, India,

Pakistan, France and United Kingdom (Information obtained from

Servier (M) Sdn. Bhd on 4th

April 2013)


(JUNE 2013)

Bil.

TEST PRODUCTS

(Pharmaceutical

name)

Comparator Products



129. Indomethacin INDOCID CAPSULE 25MG MAL19930412AS

MERCK SHARP & DOHME

(AUSTRALIA) PTY LTD

INDOCID CAPSULE 25MG

MAL19861080A

MERCK SHARP & DOHME

INT, UNITED STATES

As agreed upon in Mesyuarat Jawatankuasa Kerja Bioekuivalens Kebangsaan 1/2013 13 March 2013, the above products can be obtained from Aspen Pharmacare Australia and manufactured by Aspen

Pharmacare South Africa.

130. Isosorbide Dinitrate ISORDIL ORAL TABLET 10MG MAL19871489A

WYETH CANADA

ISORDIL SUBLINGUAL TABLET

5MG

PBKD871488A

WYETH CANADA

131. Isotretinoin ROACCUTANE ROCHE CAPSULE 20MG

PBKD861795A

F. HOFFMAN-LA ROCHE,

SWITZERLAND

ROACCUTANE ROCHE CAPSULE

10MG

PBKD861794A

F. HOFFMAN-LA ROCHE,

SWITZERLAND

ROACCUTANE CAPSULE 20MG

MAL19991721AC

R. P. SCHERER GMBH,

GERMANY

ROACCUTANE CAPSULE 10MG

MAL19991720A

132. Ketorolac Tromethamine

TORADOL 10 MG FILM-COATED

TABLET

MAL19973601A

ROCHE FARMA S.A,

SPAIN

133. Ketotifen fumarate ZADITEN 1MG TABLET MAL20000272A

NOVARTIS PHARM UK

LTD, UNITED KINGDOM

134. Labetalol TRANDATE TABLET 100MG, MAL19870059A

GLAXOSMITHKLINE

AUSTRALIA PTY LTD,

AUSTRALIA

135. Lansoprazole PREVACID 30MG CAPSULE MAL19961284AR

TAKEDA

PHARMACEUTICAL

COMPANY LIMITED,

JAPAN

This product is available in Anguilla, Aruba, Austria, Bahamas,

Bahrain, Barbados, Belgium, Benin, Bermuda Botswana, Burkina Faso,

Cambodia, Cameroon, Canada ,Cayman Islands, Chad,China,

Colombia, Congo, Costa Rica, Cote D'ivoire, Curacao, Dominican

Republic Ecuador, Egypt, El Salvador, France, Gabon, Germany,

Greece, Grenada, Guatemala, Guinea, Haiti, Honduras, Hungary, Iraq,


(JUNE 2013)

Bil.

TEST PRODUCTS

(Pharmaceutical

name)

Comparator Products



Italy, Ivory Coast, Jamaica Japan, Jordan, Jordan, Korea, Republic Of

[Kr] [South Korea], Kuwait, Lebanon Libyan Arab Jamahiriya,

Luxembour, Madagascar, Mali, Mauritania, Mexico, Morocco,

Myanmar, Namibia, Netherland, Nicaragua, Niger, Oman, Pakistan ,

Panama, Peru, Philippines, Portugal, Qatar, Saint Lucia, Saudi Arabia,

Senegal Singapore, South Africa, Spain, Switzerland, Syrian Arab

Republic, Taiwan, Province Of China, Thailand, Togo,Trinidad And

Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom,

United States, Venezuela, Yemen (information obtained from Invida

dated 25th

February 2013)

136. Leflunomide ARAVA 10MG TABLET MAL20001528A

ARAVA 20MG TABLET

MAL20001527A

ARAVA TABLET 100MG

MAL20001529A

SANOFI WINTHROP

INDUSTRIE, FRANCE

137. Levamisole hydrochloride

ERGAMISOL TABLET 50MG

MAL19990537A

JANSSEN

PHARMACEUTICA N.V.,

BELGIUM

138. Levetiracetam KEPPRA 250MG FILM COATED TABLET

MAL20031725A

KEPPRA 500MG FILM COATED

TABLET

MAL20031726A

KEPPRA 1000MG FILM COATED

TABLET

MAL20031727A

UCB S.A. SECTOR

PHARMA, BELGIUM

139. Levocetirizine dihydrochloride

XYZAL 5MG FILM COATED

TABLET

MAL20051323AR

UCB FARCHIM S.A.,

SWITZERLAND

140. Levonorgestrel POSTINOR-2 TABLET 0.75MG MAL19872263AR

GEDEON RICHTER PLC,

HUNGARY

141. Levothyroxine sodium

OROXINE 100MCG TABLET

MAL06071058A

OROXINE 50MCG TABLET

MAL06071059A

ASPEN BAD OLDESLOE

GMBH, GERMANY

142. Linezolid ZYVOX 400MG TABLETS MAL20020873AR

ZYVOX 600MG TABLETS

MAL20020874AR

PFIZER

PHARMACEUTICALS LLC,

PUERTO RICO


(JUNE 2013)

Bil.

TEST PRODUCTS

(Pharmaceutical

name)

Comparator Products



143. Lomefloxacin hydrochloride

MAXAQUIN 400MG TABLET

MAL19940539A

SEARLE DE MEXICO,

MEXICO

MAXAQUIN 400MG TABLET

MAL19940540AS

MONSANTO FRANCE SA,

FRANCE

144. Lomustine CEENU CAPSULE 40MG MAL19991719A


S.R.L., ITALY

145. Loperamide IMODIUM CAPSULE 2MG MAL19871473AR

JANSSEN CILAG, FRANCE

146. Mebeverine DUSPATALIN TABLET 100MG MAL19920644A

ABBOTT BIOLOGICALS

B.V., NETHERLAND

DUSPATALIN TABLET 135MG

MAL19940428A

ABBOTT HEALTHCARE

SAS, FRANCE

147. Meclozine As agreed upon in Mesyuarat Jawatankuasa Kerja Bioekuivalens Kebangsaan 2/2012 26 Disember 2012, the following requirement to be submitted in place of bioequivalence report :-

i) Validation process report for 3 consecutive batches ii) Comparative dissolution profile for 3 consecutive batches


148. Medroxyprogesterone acetate

FARLUTAL TABLET 100MG

MAL19991379A

FARLUTAL TABLET 500MG

MAL19991380A


ITALY

PROVERA TABLET 5MG

MAL19872113A

PHARMACIA & UPJOHN

CO, UNITED STATES

PROVERA 10MG TABLET

MAL20000997A

PROVERA 5MG TABLET

MAL06051306A

PFIZER

PHARMACEUTICAL LLC,

PUERTO RICO

149. Mefenamic acid

PONSTAN TABLET 500MG

MAL19990598AS

PT PFIZER (INDONESIA)

PONSTAN CAPSULES

MAL19985093A

PFIZER PHARM LTD,

CHINA

This product can be obtained from Hong Kong and New Zealand

(Information obtained via an email dated 7th

September 2012 from

Pfizer, Malaysia)

150. Mefloquine hydrochloride

LARIAM TABLET 250MG

MAL19921123A

F.HOFFMAN-LA ROCHE,

SWITZERLAND

151. Megestrol acetate MEGACE TABLET 160MG MAL19962089A


AUSTRALIA PTY LTD,

AUSTRALIA


(JUNE 2013)

Bil.

TEST PRODUCTS

(Pharmaceutical

name)

Comparator Products



MEGACE TABLET 40MG

MAL19962090A

HAUPT PHARMA

REGENSBURG GMBH,

GERMANY

152. Melphalan ALKERAN TABLETS 2MG MAL07101257AC

EXCELLA GMBH,

GERMANY

153. Memantine hydrochloride

EBIXA FILM-COATEDTABLET

10MG

MAL20061488ACR

EBIXA FILM-COATED TABLET 20

MG

MAL10120014ACR

ROTTENDORF PHARMA

GMBH, GERMANY

154. Mequitazine PRIMALAN TABLET 5MG MAL19871736A

MAY & BAKER LTD,

UNITED KINGDOM

155. Mercaptopurine PURI-NETHOL TABLET 50MG MAL19861668A

THE WELLCOME

FOUNDATION LTD,

UNITED KINGDOM

156. Mesterolone PROVIRONUM TABLET 25MG MAL09122025AC

SCHERING DA BRASIL

QUIMICAE

FARMACEUTICA LTDA.,

BRAZIL

157. Methimazole TAPAZOLE (T-1765) TABLET 5MG 1986042151A

ELI LILLY &C0 (TAIWAN)

INC, TAIWAN

158. Methoxsalen OXSORALEN-ULTRA CAPSULES 10MG

MAL19920052A

ICN PHARM INC, UNITED

STATES

MELADININE TABLET 10MG

MAL05090015AC

LABOBORATOIRES

MACORS, FRANCE

159. Methyldopa ALDOMET-M 125MG TABLET MAL19920191A

ALDOMET 250MG TABLET

(AUSTRALIA)

MAL19920190A

MERCK SHARP & DOHME


AUSTRALIA

As agreed upon in Mesyuarat Jawatankuasa Kerja Bioekuivalens Kebangsaan 1/2013 13 March 2013, the above products can be obtained from Aspen Pharmacare Australia and manufactured by Aspen

Pharmacare South Africa.

160. Methylphenidate hydrochloride

RITALIN TABLET 10MG

MAL19910002A

NOVARTIS

FARMACEUTICA S.A.,

SPAIN

161. Methylprednisolone MEDROL TABLET 4MG MAL19990558A

PHARMACIA & UPJOHN

CO, UNITED STATES


(JUNE 2013)

Bil.

TEST PRODUCTS

(Pharmaceutical

name)

Comparator Products



MEDROL TABLET 16MG

MAL19990559A

162. Metoclopramide hydrochloride

MAXOLON TABLET 10MG

MAL19921400A

BEECHAM PHARM,

UNITED KINGDOM

This product can be obtained from South Africa and Pakistan.

(Information obtained via email dated 26th

Sept 2012 from GSK,

Malaysia)

163. Mianserin hydrochloride

TOLVON TABLET 10MG

MAL19900637A

TOLVON TABLET 30MG

MAL19900638A

TOLVON TABLET 60MG

MAL19900639A

N.V. ORGANON,

NETHERLANDS

164. Midazolam DORMICUM ROCHE TABLET 7.5 MG

MAL19890299A

DORMICUM FILM-COATED

TABLET 15MG

MAL19920037A

PRODUCTOS ROCHE

MEXICO

F.HOFFMAN-LA ROCHE,

SWITZERLAND

165. Miglitol DIASTABOL 50MG MAL19990973A

DIASTABOL 100MG

MAL19990974A

BAYER AG, GERMANY

166. Milnacipran hydrochloride

IXEL 25MG HARD CAPSULES

MAL20061611A

IXEL 50MG HARD CAPSULES

MAL20061612A

PIERRE FABRE

MEDICAMENT

PRODUCTION, FRANCE

167. Minoxidil LONITEN 5MG TABLETS MAL20014500AR

LONITEN 10MG TABLETS

MAL20014501AR

GLOBAL PHARM LTD,

CANADA

LONITEN TABLET 5MG

MAL19861624A

LONITEN TABLET 10MG

MAL19861623A

UPJOHN LTD, UNITED

KINGDOM

This product can be obtained from Australia, Brazil, Canada, France,

Germany, Ireland, Italy, Netherlands, New Zealand, South Africa,

Spain, Switzerland, Taiwan & United Kingdom (Information

obtained via email dated 3rd

May 2013 from Zeullig Pharma Sdn. Bhd.,

Malaysia)

168. Misoprostol CYTOTEC TABLET 200MCG MAL19890225AR

PIRAMAL HEALTHCARE

UK LIMITED, UNITED


(JUNE 2013)

Bil.

TEST PRODUCTS

(Pharmaceutical

name)

Comparator Products



KINGDOM

169. Mizolastin MIZOLLEN TABLET 10MG MAL20001215A

SANOFI WINTHROP

INDUSTRIE, FRANCE

170. Moclobemide AURORIX FILM-COATED TABLET 150MG

MAL19910811A

AURORIX FILM-COATED TABLET

300MG

MAL19987972A

F.HOFFMANN-LA ROCHE

LTD, SWITZERLAND

171. Montelukast sodium SINGULAIR TABLET 10MG MAL19990957AR

MERCK SHARP & DOHME

LTD, UNITED KINGDOM

172. Morphine sulphate KAPANOL CAPSULES 20MG MAL19984000AR

KAPANOL CAPSULES 50MG

MAL19984001AR

KAPANOL CAPSULES 100MG

MAL19984002AR

F.H. FAULDING & CO LTD,

AUSTRALIA

173. Moxifloxacin hydrochloride

AVELOX TABLET

MAL20012664A

BAYER SCHERING

PHARMA AG,

LEVERKUSEN, GERMANY

174. Moxonidine PHYSIOTENS 0.2MG TABLET MAL20033335AR

PHYSIOTENS 0.3MG TABLET

MAL20033336AR

PHYSIOTENS 0.4MG TABLET

MAL20033337AR

ABBOTT HEALTHCARE

SAS, FRANCE

175. Naltrexone hydrochloride

REVIA TABLET 50MG

MAL20013367A

DUPONT PHARM

COMPANY, UNITED

STATES

176. Nateglinide STARLIX 60MG TABLET MAL20014476A

STARLIX 120MG TABLET

MAL20014477A


ITALY

177. Nebivolol NEBILET TABLET MAL20041163A

BERLIN-CHEMIE AG,

GERMANY

178. Neostigmine bromide PROSTIGMIN ROCHE TABLET 15MG

MAL19871818A

ROCHE PRODUCTS LTD,

UNITED KINGDOM

179. Nimodipine NIMOTOP TABLET 30MG MAL19940001A

BAYER SCHERING

PHARMA AG,

LEVERKUSEN, GERMANY


(JUNE 2013)

Bil.

TEST PRODUCTS

(Pharmaceutical

name)

Comparator Products



180. Nisoldipine SYSCOR CC 10MG TABLET MAL20000264AC

SYSCOR CC TABLET 20MG

MAL20000265AC


MAL20000266AC


MAL20000267AC

BAYER AG, WEST

GERMANY

181. Nizatidine PU 3144 AXID CAPSULE 150MG MAL19950508AC

LILLY S.A., SPAIN

182. Norethisterone PRIMOLUT-N TABLET 5MG MAL19900564A

ZUELLIG PHARMA SDN

BHD

183. Norgestrel POSTINOR-2 TABLET 0.75MG, MAL19872263AR

GEDEON RICHTER PLC,

HUNGARY

184. Nystatin MYCOSTATIN ORAL TABLET 500000 IU

MAL19921327A


PTY LTD, AUSTRALIA

This product can be obtained from Mexico. (Information obtained via

email dated 13th December 2012 from Bristol Myers Squibb, Asia

Pacific)

As agreed upon JKKBE 1/2013 Meeting dated 13th Mac 2013,

bioequivalence study can be waived. However, in-vitro comparative

dissolution profile study between the test and reference product need to

be performed and proved similarity.

185. Ondansetron hydrochloride

dihydrate

ZOFRAN TABLET 4MG

MAL19950007ACR

ZOFRAN TABLET 8MG

MAL19950013ACR

ASPEN BAD OLDESLOE

GMBH, GERMANY

186. Orlistat XENICAL CAPSULE 120MG MAL19992994A

F.HOFFMANN,LA ROCHE

LTD, SWITZERLAND

XENICAL CAPSULE 120 MG

MAL05032548A

ROCHE S.P.A., ITALY

187. Orphenadrine citrate NORFLEX TABLET 100MG MAL19861502A

INOVA

PHARMACEUTICALS


AUSTRALIA

188. Oxcarbazepine TRILEPTAL 600MG TABLETS MAL20021156A

NOVARTIS PHARMA


TRILEPTAL 600 MG FILM-COATED

TABLET


ITALY


(JUNE 2013)

Bil.

TEST PRODUCTS

(Pharmaceutical

name)

Comparator Products



MAL07050038AS

189. Oxybutynin hydrochloride

DRIPTANE TABLET 5MG

MAL19991351AR

LABS FOURNIER SA,

FRANCE

190. Oxycodone hydrochloride

OXYNORM 5MG CAPSULES

MAL10070560AC


MAL10070561AC


MAL10070562AC

BARD

PHARMACEUTICALS

LIMITED, UNITED

KINGDOM

191. Oxymetholone ANAPOLON 50 TABLET MAL19870679A

SYNTEX INCORPORATED,

CANADA

ANAPOLON 50 TABLET

MAL19870678A

SYNTEX PHARM LTD,

UNITED KINGDOM

192. Pantoprazole CONTROLOC 20MG TABLET MAL20032151A

CONTROLOC 40MG TABLET

MAL19972093AR

NYCOMED GMBH,

GERMANY

193. Paricalcitol ZEMPLAR CAPSULES 1 MCG MAL20071708AC

ZEMPLAR CAPSULES 2 MCG

MAL20071709AC

ZEMPLAR CAPSULES 4 MCG

MAL20071710AC

CATALENT PHARMA

SOLUTIONS, LLC, UNITED

STATES

194. Penicillamine ARTAMIN CAPSULE 250MG MAL20021153AC

HAUPT PHARMA BERLIN

GMBH, GERMANY

195. Pentoxifylline TRENTAL 400 TABLET MAL19990996A

SANOFI-AVENTIS DE

MEXICO SA DE CV

196. Phenobarbitone GARDENAL TABLET 30MG MAL19871467A

MAY & BAKER (INDIA)

LTD, INDIA

197. Phentermine DUROMINE CAPSULE 15MG MAL19871769AR

DUROMINE CAPSULE 30MG

MAL19871774AR

INOVA

PHARMACEUTICALS


AUSTRALIA

INOVA

PHARMACEUTICALS


AUSTRALIA

As agreed upon in Mesyuarat Jawatankuasa Kerja Bioekuivalens Kebangsaan 1/2013- 13 March 2013 :


(JUNE 2013)

Bil.

TEST PRODUCTS

(Pharmaceutical

name)

Comparator Products



i) Phentermine remain in BE list requirement.

ii) For Generic immediate release, oral solid dosage form product which

follows USP specification and bioequivalence study is not conducted,

the label need to state Not Interchangeable with Duromine and other

brand of product Containing Phentermine Resin.

iii) For Generic immediate release, oral solid dosage form product

which does not follow USP specification and bioequivalence study is

also not conducted, the label need to include statement no. (ii).

iv) For Generic immediate release, oral solid dosage form product

which performed BE study and found bioequivalent with Innovator

product (Duromine), there is no requirement to include the statement no.

(ii).

198. Phthalylsulphathiazole

THALAZOLE TABLET 500MG

MAY & BAKER LTD,

UNITED KINGDOM

199. Pindolol VISKEN TABLET 5MG PBKD870587A

VISKEN TABLET 10MG

PBKD870074A

NOVARTIS PHARMA AG,

SWITZERLAND

200. Pioglitazone ACTOS 15MG TABLET MAL20051432AR

ACTOS 30MG TABLET

MAL20051431AR

ACTOS 15MG TABLETS

MAL11100026ACR

TAKEDA

PHARMACEUTICAL LTD.,

JAPAN

TAKEDA

PHARMACEUTICAL LTD.,

JAPAN

DAITO

PHARMACEUTICAL

TOYOMA, JAPAN

201. Pipemidic acid URIXIN FILMTAB TABLET MAL19910050A

URIXIN FILMTAB 400MG

MAL19871869A

ABBOTT LABS,

PHILIPPINES

202. Piracetam NOOTROPIL TABLET 800 MG MAL07021408A

NOOTROPIL TABLET 1200 MG

MAL07021409A

UCB S.A. - SECTEUR

PHARMA, BELGIUM

203. Pizotifen malate SANDOMIGRAN TABLET 0.5MG MAL19860378A


ITALY

204. Pravastatin sodium PRAVACHOL TABLET 10MG BRISTOL-MYERS SQUIBB


(JUNE 2013)

Bil.

TEST PRODUCTS

(Pharmaceutical

name)

Comparator Products



MAL20032161A

PRAVACHOL TABLET 40MG

MAL19991374A

PTY LTD, AUSTRALIA

This products can be obtained from Canada, France, Germany,

Ireland and United Kingdom (Information obtained from Bristol

Myers Squibb Asia Pacific via an email dated 27th

March 2013)

205. Prazosin MINIPRESS TABLET 1MG MAL19870096A

MINIPRESS TABLET 2MG

MAL19870098A


MAL19870100A


LTD.


MAL19930148AC


MAL19930149AC


MAL19930150AC

PHARMANIAGA

MANUFACTURING

BERHAD

206. Primaquine phosphate

PRIMAQUINE TABLET

MAL19911192X

ASTRAZENECA UK

LIMITED, UNITED

KINGDOM

207. Primidone MYSOLINE 250MG TABLETS UNITED KINGDOM

208. Probenecid BENEMID TABLET 0.5G MAL19870994A

MERCK SHARP & DOHME

INT, UNITED STATES

209. Procaterol hydrochloride

MEPTIN TABLET 0.05MG

MAL19890453AC

OTSUKA

PHARMACEUTICAL CO.,

LTD, JAPAN

210. Prochlorperazine maleate

STEMETIL TABLET 5MG

MAL19861398A

MAY & BAKER LTD,

UNITED KINGDOM

This product can be obtained from Bangladesh, Denmark, Hong

Kong, Jamaica, Malta, Mauritius, Namibia, Pakistan, Thailand,

Ireland, South Africa and United Kingdom.

(Information obtained via an email dated 21st Sept 2012 from Sanofi

Aventis Malaysia)

211. Progesterone UTROGESTAN CAPSULE 100MG MAL19971796A

BESINS

MANUFACTURING

BELGIUM, BELGIUM

212. Proguanil hydrochloride

PALUDRINE TABLETS 100MG

PBKD911193A

ASTRAZENECA UK

LIMITED, UNITED

KINGDOM


(JUNE 2013)

Bil.

TEST PRODUCTS

(Pharmaceutical

name)

Comparator Products



213. Promethazine PHENERGAN TABLET 10MG PHENERGAN TABLET 25MG

SANOFI AVENTIS,

UNITED KINGDOM

214. Propafenone RYTMONORM TABLET 150MG MAL19880156A

ABBOT GMBH & CO. KG,

GERMANY

215. Propantheline PRO-BANTHINE TABLET 15MG PBKD861516A

PRO-BANTHINE TABLET 15MG

PBKD861515A

SEARLE LABS,

AUSTRALIA.

G.D. SEARLE & CO,

UNITED KINGDOM

216. Propiverine MICTONORM TABLET MAL20061584A

APOGEPHA

ARZNEIMITTEL GMBH,

GERMANY

217. Propylthiouracil PROPYLTHIOURACIL TABLET B.P. 50MG

EVANS MEDICAL LTD,

UNITED KINGDOM

218. Pseudoephedrine SUDAFED TABLET 60MG, MAL19870799A

WELLCOME AUSTRALIA

LTD, AUSTRALIA

As agreed upon in Mesyuarat Jawatankuasa Kerja Bioekuivalens Kebangsaan 1/2013 13 March 2013: Sudafed Tablet 60mg from different manufacturer (registered in other country) can also be used as a

comparator.

219. Pyridostigmine bromide

MESTINON TABLET 10MG

MAL05090001ACR

LABIANA

PHARMACEUTICALS, SL,

SPAIN

MESTINON DRAGEES 60MG

MAL04112698ACR

220. Repaglinide NOVONORM TABLET 0.5MG

MAL20001007AC


PHARMA KG, WEST

GERMANY

NOVONORM TABLET 1.0MG

MAL20001008AC

NOVONORM TABLET 2.0MG

MAL20001009AC


PHARMA GMBH & CO.KG,

WEST GERMANY

221. Reserpine SERPASIL TABLET 0.10MG 1986044940A

SERPASIL TABLET 0.25MG

1986044921A

NOVARTIS PHARMA


222. Ribavirin REBETOL CAPSULES 200MG MAL20001524A

SCHERING-PLOUGH

LABO N.V., BELGIUM

COPEGUS FILM-COATED TABLET

200MG

MAL05012334A

HOFFMANN-LA ROCHE

INC, UNITED STATES

COPEGUS FILM COATED TABLET

200MG

PATHEON INC, CANADA


(JUNE 2013)

Bil.

TEST PRODUCTS

(Pharmaceutical

name)

Comparator Products



MAL08051760ACS

223. Rifabutin MYCOBUTIN 150MG CAPSULES MAL19960957A

PFIZER ITALIA S.R.L.

224. Riluzole RILUTEK TABLETS 50MG MAL20051294A

SANOFI WINTHROP

INDUSTRIE, FRANCE

225. Risedronate sodium ACTONEL FILM-COATED TABLET 5MG

MAL20012657AR

ACTONEL 30MG TABLET

MAL20012656AR

OSG NORWICH PHARM

INC, UNITED STATES

ACTONEL 35MG TABLET

MAL20034605AR

NORWICH

PHARMACEUTICALS INC.,

UNITED STATES

226. Rivastigmine hydrogen tartrate

EXELON 1.5MG CAPSULES

MAL19990976A

EXELON 3MG CAPSULES

MAL19990977A

EXELON 4.5MG CAPSULES

MAL19990978A

EXELON 6MG CAPSULES

MAL19990979A

NOVARTIS

FARMACEUTICA S.A.,

SPAIN

227. Rizatriptan benzoate MAXALT TABLET 5MG MAL20000249AR

MAXALT TABLET 10MG

MAL20000250AR

MERCK SHARP & DOHME

LTD, UNITED KINGDOM

228. Ropinirole hydrochloride

REQUIP TABLET 0.25MG

MAL19990966A

REQUIP TABLET 1MG

MAL19990967A

REQUIP TABLET 2MG

MAL19990968A

REQUIP TABLET 5MG

MAL19990969A

SMITHKLINE BEECHAM

PHARM, UNITED

KINGDOM

229. Rosiglitazone AVANDIA TABLET 2MG MAL20000007A

AVANDIA TABLET 4MG

MAL20000008A

AVANDIA TABLET 8MG

MAL20000009A

GLAXO WELLCOME S.A.,

SPAIN

230. Rosuvastatin calcium CRESTOR 10MG TABLET MAL20041089AR

IPR PHARMACEUTICALS

INC, PUERTO RICO


(JUNE 2013)

Bil.

TEST PRODUCTS

(Pharmaceutical

name)

Comparator Products



CRESTOR 20MG TABLET

MAL20051357AR

231. Selegiline JUMEX TABLET 5MG MAL19950723A

CHINOIN

PHARMACEUTICAL AND

CHEMICAL WORKS PVT.

CO. LTD., HUNGARY

232. Sevelamer Carbonate

RENVELA (SEVELAMER

CARBONATE) TABLETS

MAL20102007A

GENZYME IRELAND

LIMITED, IRELAND

As agreed upon Mesyuarat Dasar Regulatori 1/2013 dated 20th

Mac

2013, bioequivalence study is not required. However, the following are

the studies that need to perform in order to support interchangeability

between the test and comparator product:-

1. In-Vitro Equilibrium Binding Study

2. In-Vitro Kinetic Binding Study

233. Sildenafil citrate VIAGRA 25MG TABLET MAL19990542A

VIAGRA 50MG TABLET

MAL19990543A

VIAGRA 100MG TABLET

MAL19990544A

PFIZER INC, UNITED

STATES

VIAGRA 25MG TABLET

MAL20012709AS

VIAGRA 50MG TABLET

MAL20012710AS

VIAGRA 100MG TABLET

MAL20012711AS


LTD., AUSTRALIA

234. Sodium Iodide SODIUM IODIDE (1311) THERAPY CAPSU*

MAL19930360A

GE HEALTHCARE

LIMITED, UNITED

KINGDOM

235. Sodium fusidate FUCIDIN TABLET 250MG (FILM COATED)

MAL19910821A

LEO PHARM PRODUCTS,

DENMARK

236. Sodium rabeprazole PARIET TABLET 10MG MAL19992540A

PARIET TABLET 20MG

MAL19992541A

EISAI CO LTD, JAPAN

237. Sorafenib tosylate NEXAVAR FILM-COATED TABLETS 200 MG

MAL20071668A

BAYER SCHERING

PHARMA AG,

LEVERKUSEN, GERMANY

238. Sotalol hydrochloride

SOTACOR TABLET 80MG

MAL19930231A

BRISTOL-MYERS CO LTD,

UNITED KINGDOM


(JUNE 2013)

Bil.

TEST PRODUCTS

(Pharmaceutical

name)

Comparator Products



SOTACOR TABLET 160MG

MAL19930232A

SOTACOR TABLET 80MG

MAL19940601AS

SOTACOR TABLET 160MG

MAL19940602AS


PTY LTD, AUSTRALIA

239. Spiramycin ROVAMYCINE TABLET 1.5 MILLION IU

MAL19890558A

ROVAMYCINE 3 M.I.U. TABLETS

MAL19962132A

FAMAR LYON, FRANCE

240. Spironolactone ALDACTONE TABLET 100MG MAL19870236A

SEARLE LABS,

AUSTRALIA

This product is available in Argentina, Aruba, Australia, Bahamas,

Bahrain, Barbados, Belgium, Belize, Bermuda, Brazil, Cambodia,

Canada, Colombia, France, Ghana, Greece, Hong Kong, Iceland,

Ireland, Israel, Jamaica, Japan, Kenya, Kuwait, Lebanon, , Korea,

Mexico, Myanmar, Nigeria, Norway, Oman, Phillipines, Qatar, Saudi

Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand,

UK, UAE, Vietnam.

(Information obtained from Pfizer Malaysia dated 10th

June 2013 via an

email)

241. Sulindac CLINORIL 200MG TABLET MAL19950546A

MERCK SHARP & DOHME


AUSTRALIA

242. Sulodexide VESSEL DUE F 250 LSU CAPSULE MAL19992679A

ALFA WASSERMANN

S.P.A., ITALY

243. Sulphasalazine SALAZOPYRIN EN TABLET 500MG MAL19950470A

KEMWELL AB, SWEDEN

244. Sultamicillin tosylate UNASYN TABLET MAL19910104A

PFIZER JAPAN INC

UNASYN ORAL TABLET 375MG

MAL20020026ACS

PHARMANIAGA

MANUFACTURING

BERHAD

245. Sumatriptan succinate

IMIGRAN TABLET 50MG

MAL19973576AR

GLAXOSMITHKLINE

PHARMACEUTICALS SA,

POLAND

IMIGRAN TABLET 100MG

MAL19950008A

GLAXO WELLCOME

OPERATIONS UK LTD,

UNITED KINGDOM

246. Tegafur FUTRAFUL CAPSULE 200MG MAL19861648A

TAIHO PHARM CO LTD,

JAPAN


(JUNE 2013)

Bil.

TEST PRODUCTS

(Pharmaceutical

name)

Comparator Products



247. Telmisartan MICARDIS TABLET 20MG MAL20014487A

MICARDIS TABLET 40MG

MAL19992673A

MICARDIS TABLET 80MG

MAL19992674A


PHARMA GMBH & CO.KG,

WEST GERMANY

248. Temozolomide TEMODAL CAPSULES 5MG MAL07082878ACR

TEMODAL CAPSULES 5 MG

MAL06071048ACRS

TEMODAL CAPSULES 20MG

MAL07082880ACR


MAL06071049ACRS


MAL07082881ACR


MAL06071051ACRS

ORION CORPORATION,

ORION PHARMA,

FINLAND


MAL20032408AR


MAL20032409AR


MAL20032410AR

INTEGRATED

THERAPEUTICS GROUP

INC, UNITED STATES

249. Tenoxicam TILCOTIL`ROCHE`LACQ-COATED TAB 20MG

MAL19890224A

F.HOFFMAN-LA ROCHE,

SWITZERLAND

250. Terazosin hydrochloride

HYTRIN 1MG TABLET

MAL20014488AC

HYTRIN 2MG TABLET

MAL20014489AC

HYTRIN 5MG TABLET

MAL20014490AC

AESICA QUEENBOROUGH

LIMITED, UNITED

KINGDOM

251. Testosterone Undecanoate

ANDRIOL TESTOCAPS CAPSULES

40MG

MAL05032535AC

ANDRIOL CAPSULE 40MG

MAL19870663A

CATALENT FRANCE

BEINHEIM SA, FRANCE

R.P SCHERER GMBH & CO

KG, GERMANY

252. Thioguanine LANVIS TABLETS 40MG MAL05032537ACR

DSM PHARMACEUTICALS

INC, UNITED STATES

253. Thyroxine sodium ELTROXIN TABLET 0.05 MG GLAXO WELLCOME


(JUNE 2013)

Bil.

TEST PRODUCTS

(Pharmaceutical

name)

Comparator Products



MAL19890455A

ELTROXIN TABLET 0.1MG

MAL19890456A

OPERATIONS UK LTD

254. Tibolone LIVIAL TABLET 2.5MG MAL19913394A

N.V. ORGANON,

NETHERLANDS

255. Tolbutamide RASTINON TABLET 500MG MAL19870403A

AVENTIS PHARMA

DEUTSCHLAND GMBH,

WEST GERMANY

This product can be obtained from Japan, Australia, Hong Kong and

Mexico (Information obtained via an email dated 2nd

Oct 2012 from

Sanofi Aventis, Malaysia)

256. Tolterodine l-tartrate

DETRUSITOL TABLET 2MG

MAL19991686A


ITALY

257. Topotecan hydrochloride

HYCAMTIN 0.25MG HARD

CAPSULES

MAL20091960A

HYCAMTIN 1 MG HARD

CAPSULES

MAL20091961A

GLAXOSMITHKLINE

MANUFACTURING S.P.A,

ITALY

258. Tranexamic Acid TRANSAMIN CAPSULE 250MG MAL19890202AC

TRANSAMIN CAPSULE 250MG

CMIC CMO CO. LTD,

JAPAN

DAIICHI

PHARMACEUTICAL LTS,

JAPAN

259. Tramadol hydrochloride

TRAMAL CAPSULE

MAL19921516A

GRUNENTHAL GMBH,

WEST GERMANY

Product is available in Australia, Austria, Bahrain, Belgium, China,

Croatia, Denmark, Finland, France, Germany, Greece, Ireland,

Israel, Italy, Jordan, Kenya, Kuwait, Lebanon, New Zealand,

Netherlands, Nigeria, Norway, Oman, Portugal, Poland, Qatar,

Saudia Arabia, Sweden, Taiwan, Thailand, Switzerland, UAE, UK,

Yemen

(Information obtained via an email from Grunenthal Gmbh, Germany

dated 28th

March 2013)

260. Triazolam SOMESE TABLET 0.25 MG MAL07050020ACR

SANICO N.V., BELGIUM

261. Triflusal GRENDIS 300MG CAPSULE MAL20051420A

J. URIACH & CIA,S.A.,

SPAIN

262. Trimebutine maleate DEBRIDAT TABLET 1990040029A

JOUVEINAL LABS,

FRANCE

263. Trimetazine hydrochloride

VASTAREL COATED TABLET

20MG

LES LABS SERVIER

INDUSTRIE, FRANCE


(JUNE 2013)

Bil.

TEST PRODUCTS

(Pharmaceutical

name)

Comparator Products



MAL19870169A

264. Ursodeoxycholic acid URSOFALK CAPSULE 250MG MAL19990011ACS

LOSAN PHARMA GMBH,

GERMANY

265. Vigabatrin SABRIL 500MG TABLET MAL19961357A

PATHEON FRANCE S.A.,

FRANCE

266. Vinorelbine tartrate NAVELBINE 20MG SOFT CAPSULE MAL20071635A

NAVELBINE 30MG SOFT CAPSULE

MAL20071636A

PIERRE FABRE

MEDICAMENT

PRODUCTION, FRANCE

267. Voriconazole VFEND 50MG TABLET MAL20040542A

VFEND 200MG TABLET

MAL20040543A

PFIZER

MANUFACTURING

DEUTSHLAND GMBH,

GERMANY

268. Ziprasidone hydrochloride

ZELDOX CAPSULE 20MG

MAL20032622A

ZELDOX CAPSULE 40MG

MAL20032623A

ZELDOX CAPSULE 60MG

MAL20032624A

ZELDOX CAPSULE 80MG

MAL20032625A


LTD., AUSTRALIA

269. Zofenopril calcium BIFRIL 30 MAL20061470A

A. MENARINI

MANUFACTURING

LOGISTICS AND

SERVICES S.R.L., ITALY

270. Zuclopenthixol CLOPIXOL TABLET 10MG MAL19890537A

H.LUNDBECK A/S,

DENMARK

271. Cycloserine CYCLOSERINE CAPSULE BP 250MG

MAL19900001A

ELI LILLY AND

COMPANY LIMITED,

UNITED KINGDOM

Note:

If you need further clarification, kindly email to [email protected] and

[email protected]

Updated on 11/06/2013

List of Comparator Products for Bioequivalence Studies11062013 V1

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