List of Comparator Products For Bioequivalence Studies - BPFK
List of Comparator Products For Bioequivalence Studies - BPFK
List of Comparator Products For Bioequivalence Studies - BPFK
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LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES<br />
(NOVEMBER 2012)<br />
TEST PRODUCTS<br />
<strong>Comparator</strong> <strong>Products</strong><br />
Bil. (Pharmaceutical<br />
name)<br />
Trade Mark/Registration No./<br />
Reference No.<br />
Manufacturer<br />
1. Acarbose GLUCOBAY TABLET 50MG BAYER SCHERING<br />
MAL19940745A<br />
PHARMA AG,<br />
GLUCOBAY TABLET 100MG<br />
MAL19940746A<br />
LEVERKUSEN, GERMANY<br />
2. Acebutolol<br />
SECTRAL CAPSULE 100MG MAY & BAKER LTD, MAY<br />
hydrochloride (MAL19870251A)<br />
& BAKER LTD,<br />
SECTRAL CAPSULE 200MG DAGENHAM, ESSEX,<br />
(MAL19870052A)<br />
SECTRAL TABLET 400MG<br />
(MAL19870053A)<br />
RM107XS, ENGLAND<br />
SECTRAL 200MG CAPSULE RHONE-POULENC RORER,<br />
MAL19920620A<br />
JL LAWANG GINTUNG,<br />
BOGUR, WEST JAVA,<br />
INDONESIA<br />
3. Acemetacin RANTUDIL CAPSULE 60MG BAYER AG, WEST<br />
(MAL19986936A)<br />
GERMANY<br />
4. Acetazolamide<br />
RANTUDIL RETARD 90MG<br />
CAPSULE<br />
(MAL19992054A)<br />
DIAMOX TABLET 250MG<br />
DIAMOX TABLET 250MG<br />
5. Acipimox OLBETAM CAPSULE 250 MG<br />
(MAL19900589A)<br />
6. Acitretin NEOTIGASON CAPSULE 10 MG<br />
(MAL06091392AC)<br />
NEOTIGASON CAPSULE 25 MG<br />
(MAL06091393AC)<br />
NEOTIGASON HARD GELATIN<br />
CAPSULE 10MG<br />
(MAL19921411A)<br />
NEOTIGASON HARD GELATIN<br />
CAPSULE 25*<br />
(MAL19921412A)<br />
7. Acrivastine SEMPREX CAPSULE 8MG<br />
(MAL19900013A)<br />
BAYER SCHERING<br />
PHARMA AG, GERMANY<br />
AMERICAN CYANAMID<br />
CO.,US<br />
LEDERLE LABS DIV<br />
CYANAMID, UNITED<br />
KINGDOM<br />
PHARMACIA S.P.A, ITALY<br />
PATHEON INC, CANADA<br />
ROCHE PRODUCTS LTD,<br />
UNITED KINGDOM<br />
SMITHKLINE BEECHAM<br />
PHARM, UNITED<br />
KINGDOM
LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES<br />
(NOVEMBER 2012)<br />
<strong>Comparator</strong> <strong>Products</strong><br />
Bil.<br />
TEST PRODUCTS<br />
(Pharmaceutical<br />
name)<br />
Trade Mark/Registration No./<br />
Reference No.<br />
8. Adefovir HEPSERA TABLET 10MG<br />
MAL20040907A<br />
9. Allopurinol ZYLORIC 100MG TABLETS<br />
MAL19973571AS<br />
ZYLORIC TABLET 300MG<br />
MAL19972499AS<br />
10. Allyoestrenol GESTANIN TABLET 5MG<br />
MAL19870680A<br />
11. Alverin citrate SPASMAVERINE TABLET 0.04G<br />
MAL19871806A<br />
12. Amantadine<br />
hydrochloride<br />
SYMMETREL SOFT GELATIN<br />
CAPSULE 100*<br />
1986040644A<br />
13. Amantadine sulphate PK-MERZ TABLET 100MG<br />
MAL19860850A<br />
14. Amiodarone CORDARONE 200MG<br />
hydrochloride MAL19987968AR<br />
15. Amisulpride SOLIAN 100MG SCORED TABLET<br />
MAL20032239A<br />
SOLIAN 400MG SCORED FILM-<br />
COATED TABLET<br />
MAL20032240A<br />
Manufacturer<br />
GLAXOSMITHKLINE<br />
(TIANJIN) CO. LTD.,<br />
CHINA<br />
ASPEN BAD OLDESLOE<br />
GMBH,<br />
INDUSTRIESTRASSE 32-<br />
36, D-23843 BAD<br />
OLDESLOE ,<br />
GERMANY<br />
ORGANON LABS LTD,<br />
SCOTTLAND<br />
LABORATOIR BELLON,<br />
FRANCE<br />
NOVARTIS PHARMA<br />
STEIN AG, SWITZERLAND<br />
MERZ PHARMA GMBH &<br />
CO. KGAA,GERMANY<br />
SANOFI WINTHROP<br />
INDUSTRIE, FRANCE<br />
SANOFI WINTHROP<br />
INDUSTRIE, FRANCE<br />
16. Amodiaquine CAMOQUIN PFIZER, UNITED<br />
KINGDOM<br />
17. Anastrozole ARIMIDEX TABLET 1MG<br />
ASTRAZENECA<br />
MAL19987960AR<br />
PHARMACEUTICALS LP,<br />
UNITED STATES<br />
18. Aprepitant EMEND 80MG CAPSULE<br />
MERCK SHARP & DOHME<br />
MAL20040905AR<br />
EMEND 125MG CAPSULE<br />
MAL20040906AR<br />
CORP.*, UNITED STATES<br />
19. Bacampicillin PENGLOBE TABLET 400MG ASTRAZENECA AB,<br />
hydrochloride MAL19860452AR<br />
SWEDEN<br />
20. Bacl<strong>of</strong>en LIORESAL 10MG TABLET<br />
NOVARTIS FARMA S.P.A.,<br />
MAL20000748AC<br />
ITALY<br />
21. Bacampicillin As agreed upon “Mesyuarat Jawatankuasa Kerja Bioekuivalens<br />
Kebangsaan 1/2012 – 13 September 2012, the following requirement to
Bil.<br />
LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES<br />
(NOVEMBER 2012)<br />
TEST PRODUCTS<br />
(Pharmaceutical<br />
name)<br />
<strong>Comparator</strong> <strong>Products</strong><br />
Trade Mark/Registration No./<br />
Reference No.<br />
be submitted in place <strong>of</strong> bioequivalence report :-<br />
22. Benfluorex MEDIAXAL TABLET 150MG<br />
MAL19870176A<br />
23. Benzhexol ARTANE TABLET 2MG<br />
PBKD861498A<br />
ARTANE TABLET 2MG<br />
PBKD861497A<br />
24. Benztropine COGENTIN TABLET 2MG<br />
mesylate<br />
MAL19870343AR<br />
25. Betahistine<br />
BETASERC 24MG TABLET<br />
dihydrochloride MAL07061394A<br />
BETASERC 16MG TABLETS<br />
MAL19972468A<br />
26. Betahistine mesylate MERISLON TABLET 6MG<br />
MAL19861236A<br />
27. Betamethasone BETNELAN TABLET 0.5MG,<br />
MAL19870589A<br />
Manufacturer<br />
i) Validation process report for 3 consecutive batches<br />
ii) Comparative dissolution pr<strong>of</strong>ile for 3 consecutive batches (time<br />
points : 0, 5, 15, 30 & 45 minutes )<br />
28. Betaxolol KERLONE TABLET 20MG<br />
MAL19872264A<br />
29. Bezafibrate BEZALIP COATED TABLET 200MG<br />
1993010002A<br />
30. Bicalutamide CASODEX TABLET 50MG<br />
MAL19990958ACR<br />
CASODEX 150MG TABLET<br />
MAL20040082AR<br />
31. Bisoprolol fumarate CONCOR 2.5MG TABLET<br />
MAL20020792A<br />
CONCOR 5 FILM COATED TABLET<br />
MAL19890389A<br />
CONCOR 10 FILM-COATED<br />
TABLET<br />
MAL19890390A<br />
32. Bosentan<br />
TRACLEER TABLET 62.5 MG<br />
monohydrate MAL20041084ACR<br />
TRACLEER TABLET 125 MG<br />
LES LABS SERVIER<br />
INDUSTRIE, FRANCE<br />
AMERICAN CYANAMID<br />
CO, UNITED STATES<br />
CYANAMID OF GREAT<br />
BRITAIN, UNITED<br />
KINGDOM<br />
MERCK SHARP & DOHME<br />
INT, UNITED STATES<br />
ABBOTT HEALTHCARE<br />
SAS, FRANCE<br />
EISAI CO LTD, JAPAN<br />
GLAXO WELLCOME<br />
OPERATIONS UNITED<br />
KINGDOM<br />
SANOFI WINTHROP<br />
INDUSTRIE, FRANCE<br />
ROCHE DIAGNOSTICS<br />
GMBH, GERMANY<br />
CORDEN PHARMA GMBH,<br />
GERMANY.<br />
ASTRAZENECA GMBH ,<br />
GERMANY<br />
MERCK KGAA, GERMANY<br />
PATHEON INC., CANADA
Bil.<br />
LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES<br />
(NOVEMBER 2012)<br />
TEST PRODUCTS<br />
(Pharmaceutical<br />
name)<br />
33. Brompheniramine<br />
maleate<br />
34. Buclizine<br />
hydrochloride<br />
<strong>Comparator</strong> <strong>Products</strong><br />
Trade Mark/Registration No./<br />
Reference No.<br />
MAL20041085ACR<br />
DIMETANE TABLET 4MG<br />
1986041234A<br />
LONGIFENE TABLET 25MG<br />
MAL19861193A<br />
35. Bumetanide BURINEX TABLET 1MG<br />
MAL19913216A<br />
36. Busulphan MYLERAN TABLETS 2MG<br />
MAL05051050AC<br />
37. Butropium bromide COLIOPAN TABLET 5MG<br />
MAL19910111A<br />
38. Cabergoline DOSTINEX TABLET 0.5MG<br />
MAL19971775A<br />
39. Capecitabine XELODA TABLET 150MG<br />
MAL20000001A<br />
XELODA TABLET 500MG<br />
MAL20000002A<br />
40. Carbimazole NEOMERCAZOLE TABLET 5 MG<br />
MAL05092230AC<br />
41. Cefaclor DISTACLOR CAPSULE 250MG<br />
MAL19962114A<br />
DISTACLOR CAPSULE 500MG<br />
42. Cefadroxil<br />
monohydrate<br />
MAL19962115A<br />
DURICEF CAPSULE 500MG<br />
MAL19860523A<br />
DURICEF TABLET 1GM<br />
MAL19940665A<br />
43. Cefdinir OMNICEF CAPSULE 100MG<br />
MAL19991688AC<br />
44. Cefprozil PROCEF TABLET 250MG<br />
MAL19940487A<br />
PROCEF TABLET 500MG<br />
MAL19940483A<br />
45. Ceftibuten CEDAX CAPSULE 200MG<br />
MAL19950228A<br />
CEDAX CAPSULE 400MG<br />
MAL19950227A<br />
46. Celecoxib CELEBREX CAPSULE 100MG<br />
MAL20000004AR<br />
Manufacturer<br />
A.H.ROBINS PTY LTD,<br />
AUSTRALIA<br />
UCB S.A. SECTOR<br />
PHARMA,<br />
BELGIUM<br />
LEO PHARM PRODUCTS,<br />
DENMARK<br />
EXCELLA GMBH,<br />
GERMANY<br />
EISAI TAIWAN INC,<br />
TAIWAN<br />
PFIZER ITALIA S.R.L.,<br />
ITALY<br />
PRODUCTOS ROCHE S.A<br />
DE C.V, MEXICO<br />
APTUIT (EDINBURGH)<br />
LIMITED, UNITED<br />
KINGDOM<br />
ELI LILLY &C0 (TAIWAN)<br />
INC, TAIWAN<br />
BRISTOL-M<br />
BARCELONETA INC,<br />
PUERTO RISO, UNITED<br />
STATES<br />
UPHA PHARMACEUTICAL<br />
MFG. (M) SDN BHD,<br />
MALAYSIA<br />
BRISTOL-M<br />
BARCELONETA INC,<br />
UNITED STATES<br />
SIFI S.P.A., ITALY<br />
PFIZER<br />
PHARMACEUTICAL LLC,
LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES<br />
(NOVEMBER 2012)<br />
TEST PRODUCTS<br />
<strong>Comparator</strong> <strong>Products</strong><br />
Bil. (Pharmaceutical<br />
name)<br />
Trade Mark/Registration No./<br />
Reference No.<br />
Manufacturer<br />
CELEBREX CAPSULE 200MG<br />
MAL20000005AR<br />
CELEBREX 400MG CAPSULES<br />
MAL08051748AR<br />
PUERTO RICO<br />
47. Cephradine VELOSEF CAPSULE 500MG BRISTOL-MYERS SQUIBB<br />
MAL19920468A<br />
AEBE, GREECE<br />
48. Chloroquine NIVAQUINE TABLET 200MG MAY & BAKER LTD,<br />
MAL19912313A<br />
UNITED KINGDOM<br />
49. Chlorothiazide CHLOTRIDE TABLET 500MG MERCK SHARP & DOHME<br />
REF.NO1986040263A<br />
INT, UNITED STATES<br />
50. Chlorpheniramine PIRITON TABLET 4MG<br />
HAUPT PHARMA<br />
maleate<br />
MAL07082871AC<br />
WULFING GMBH,<br />
GERMANY<br />
51. Chlorpropamide DIABENESE TABLET 250MG PFIZER AUSTRALIA PTY.<br />
MAL19986461A<br />
LTD., AUSTRALIA<br />
DIABINESE TABLET 250MG PFIZER PHARM DIV.,<br />
MAL19870382A<br />
PHILIPINES<br />
52. Chlortetracycline AUREOMYCIN CAPSULE 250MG INTERTHAI<br />
MAL19871950A<br />
PHARMACEUTICAL<br />
MANUFACTURING LTD,<br />
THAILAND<br />
53. Chlorthalidone HYGROTON TABLET 25MG NOVARTIS PHARMA<br />
PBKD870184A<br />
HYGROTON TABLET 50MG<br />
PBKD870185A<br />
STEIN AG, SWITZERLAND<br />
54. Cilostazol PLETAAL 50MG TABLETS KOREA OTSUKA<br />
MAL20061476A<br />
PHARMACEUTICAL CO<br />
PLETAAL 100MG TABLETS<br />
MAL20061475A<br />
LTD, KOREA<br />
55. Cinnarizine STUGERON 25MG TABLET JANSSEN CILAG SPA,<br />
MAL19871481A<br />
ITALY<br />
56. Clemastine fumarate TAVEGYL TABLET 1MG<br />
NOVARTIS PHARMA AG,<br />
PBKD861195A<br />
SWITZERLAND<br />
57. Clenbuterol SPIROPENT TABLET 0.01MG BOEHRINGER INGELHEIM<br />
hydrochloride MAL19870785A<br />
INTERNATIONAL GMBH,<br />
GERMANY<br />
58. Clodronate OSTAC CAPSULE<br />
ROCHE DIAGNOSTICS<br />
1989120003A<br />
GMBH, GERMANY<br />
59. Clomiphene CLOMID TABLET 50MG<br />
PATHEON FRANCE S.A.,<br />
MAL19950686A<br />
FRANCE<br />
60. Clonazepam RIVOTRIL ROCHE TABLET 0.5MG ROCHE FARMA S.A.,<br />
MAL19860961A<br />
SPAIN
LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES<br />
(NOVEMBER 2012)<br />
<strong>Comparator</strong> <strong>Products</strong><br />
Bil.<br />
TEST PRODUCTS<br />
(Pharmaceutical<br />
name)<br />
Trade Mark/Registration No./<br />
Reference No.<br />
RIVOTRIL ROCHE TABLET 2MG<br />
MAL19860962A<br />
61. Clonidine DIXARIT TABLET 25MCG<br />
MAL19870080A<br />
62. Clorazepate<br />
dipotassium<br />
DIXARIT SUGAR-COATED<br />
TABLET 0.025MG<br />
MAL19986979A<br />
CATAPRES TABLET 0.15MG<br />
MAL19861621A<br />
TRANXENE CAPSULE 5MG<br />
PBKD861331AR<br />
TRANXENE CAPSULE 10MG<br />
PBKD861332AR<br />
63. Cyproterone acetate ANDROCUR 50MG TABLET<br />
MAL19993023AR<br />
64. Dapsone AVLOSULFON TABLET 0.1G<br />
1986043833A<br />
65. Dasatinib SPRYCEL 20MG TABLET<br />
MAL20071695AR<br />
SPRYCEL 50MG TABLET<br />
MAL20071696AR<br />
SPRYCEL 70MG TABLET<br />
MAL20071697AR<br />
66. Deferiprone FERRIPROX 500MG TABLET<br />
MAL20033480AC<br />
67. Desloratadine AERIUS TABLET<br />
MAL20020876AR<br />
AERIUS TABLET 5MG<br />
MAL10053655AS<br />
68. Dexchlorpheniramin POLARAMINE 2MG TABLET<br />
e maleate<br />
69. Dexketopr<strong>of</strong>en<br />
trometamol<br />
MAL09072776A<br />
KETESSE 25MG FILM COATED<br />
TABLET<br />
MAL20061602A<br />
70. Diacerein ARTRODAR<br />
MAL20041211A<br />
71. Dicl<strong>of</strong>enac potassium VOLTAREN DOLO 12.5 MG FILM-<br />
COATED TABLETS<br />
MAL06071043A<br />
Manufacturer<br />
BOEHRINGER INGELHEIM<br />
INTERNATIONAL GMBH,<br />
GERMANY.<br />
BOEHRINGER INGELHEIM<br />
FRANCE, FRANCE.<br />
BOEHRINGER INGELHEIM<br />
LTD, SOUTH KOREA<br />
SANOFI WINTHROP<br />
INDUSTRIE, FRANCE<br />
DELPHARM LILLE S.A.S.,<br />
FRANCE<br />
ASTRAZENECA UK<br />
LIMITED, UNITED<br />
KINGDOM<br />
BRISTOL-MYERS SQUIBB<br />
COMPANY, UNITED<br />
STATES<br />
APOTEX INC CANADA<br />
SCHERING PLOUGH SPA,<br />
ITALY<br />
SCHERING-PLOUGH<br />
LABO N.V., BELGIUM<br />
SCHERING-PLOUGH<br />
LABO N.V., BELGIUM<br />
A. MENARINI<br />
MANUFACTURING<br />
LOGISTIES AND<br />
SERVICES S.R.L, ITALY<br />
TRB PHARMA S.A,<br />
ARGENTINA<br />
NOVARTIS<br />
FARMACEUTICA S.A.,<br />
SPAIN
LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES<br />
(NOVEMBER 2012)<br />
TEST PRODUCTS<br />
<strong>Comparator</strong> <strong>Products</strong><br />
Bil. (Pharmaceutical<br />
name)<br />
Trade Mark/Registration No./<br />
Reference No.<br />
Manufacturer<br />
CATAFLAM 25MG TABLETS NOVARTIS FARMA S.P.A.,<br />
MAL19960970A<br />
ITALY<br />
CATAFLAM TABLET 50MG NOVARTIS SAGLIK,<br />
MAL19960971A<br />
TURKEY<br />
72. Dicl<strong>of</strong>enac sodium VOLTAREN TABLET 25MG NOVARTIS FARMA S.P.A.,<br />
MAL19861069A<br />
VOLTAREN TABLET 50MG<br />
MAL19861068A<br />
ITALY<br />
73. Diflunisal DOLOBID TABLET 250MG MERCK SHARP & DOHME<br />
MAL19861106AR<br />
DOLOBID TABLET 500MG<br />
MAL19890178AR<br />
INT, UNITED STATES<br />
74. Dihydroergotamine SEGLOR CAPSULE 5MG<br />
SANOFI WINTHROP<br />
mesylate<br />
MAL19870274A<br />
INDUSTRIE, FRANCE<br />
75. Dimenhydrinate DRAMAMINE TABLET 50MG PROQUALIX PTY LTD,<br />
MAL19870328A<br />
AUSTRALIA<br />
76. Diphenidol<br />
hydrochloride MAL19861237A<br />
77. Dipyridamole PERSANTIN TABLET 75MG<br />
MAL19870161A<br />
This product can be obtained from Costa Rica, Dominican Republic,<br />
El Salvador, Guatemala, Honduras, Mexico, Nicarague, Panama,<br />
Colombia, Peru and Chile.<br />
(Information obtained via an email from Johnson & Johnson Malaysia<br />
dated 27 th Sept 2012)<br />
CEPHADOL TABLET 25MG NIPPON SHINYAKU CO<br />
78. Domperidone MOTILIUM TABLET 10MG<br />
MAL19872254AR<br />
79. Donepezil ARICEPT F.C. 5MG<br />
MAL20013565A<br />
ARICEPT TABLET 10MG<br />
MAL05020190AC<br />
80. Doxazosin CARDURA TABLET 2MG<br />
MAL19990562AS<br />
81. Dronedarone MULTAQ 400MG FILM-COATED<br />
Hydrochloride TABLETS<br />
MAL20102016A<br />
82. Drotaverine NO-SPA TABLETS 40MG<br />
MAL19900596A<br />
NO-SPA FORTE TABLET<br />
MAL20001801A<br />
LTD, JAPAN<br />
BOEHRINGER INGELHEIM<br />
INTERNATIONAL GMBH,<br />
GERMANY<br />
JANSSEN CILAG, FRANCE<br />
EISAI TAIWAN INC,<br />
TAIWAN<br />
PFIZER AUSTRALIA PTY.<br />
LTD., AUSTRALIA<br />
SANOFI WINTHROP<br />
INDUSTRIE, FRANCE<br />
CHINOIN<br />
PHARMACEUTICAL &<br />
CHEMICAL WORKS<br />
PRIVATE CO LTD,
Bil.<br />
LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES<br />
(NOVEMBER 2012)<br />
TEST PRODUCTS<br />
(Pharmaceutical<br />
name)<br />
Trade Mark/Registration No./<br />
Reference No.<br />
83. Dutasteride AVODART SOFT GELATIN<br />
CAPSULES<br />
84. Eletriptan<br />
hydrobromide<br />
MAL20040194AR<br />
RELPAX 20MG TABLET<br />
MAL20021359A<br />
RELPAX 40MG TABLET<br />
MAL20021360A<br />
RELPAX 80MG TABLET<br />
MAL20021361A<br />
85. Entacapone COMTAN TABLET 200MG<br />
MAL19992996A<br />
86. Entecavir BARACLUDE TABLET 0.5 MG<br />
MAL20061502AR<br />
87. Eperisone<br />
MYONAL TABLET 50MG<br />
hydrochloride MAL19940448A<br />
88. Esomeprazole NEXIUM 20MG TABLET<br />
magnesium<br />
MAL20020238AR<br />
NEXIUM 40MG TABLET<br />
MAL20020239AR<br />
89. Estradiol PROGYNOVA 1MG TABLET<br />
MAL09020971AC<br />
PROGYNOVA TABLET 2MG<br />
MAL09020972AC<br />
90. Estramustine sodium ESTRACYT CAPSULE 140MG<br />
phosphate<br />
MAL19990993A<br />
91. Etoricoxib ARCOXIA 60MG TABLET<br />
MAL20034170AR<br />
ARCOXIA 90MG TABLET<br />
MAL20034179AR<br />
ARCOXIA 120MG TABLET<br />
MAL20034182AR<br />
92. Exemestane AROMASIN TABLET 25MG<br />
MAL08111847A<br />
AROMASIN 25MG TABLETS<br />
MAL20013341A<br />
93. Ezetimibe EZETROL 10MG<br />
MAL20034627AR<br />
<strong>Comparator</strong> <strong>Products</strong><br />
94. Famciclovir FAMVIR TILTAB TABLET 250MG<br />
MAL19950237A<br />
Manufacturer<br />
HUNGARY<br />
RP SCHERER SA, FRANCE<br />
PFIZER AUSTRALIA PTY.<br />
LTD., AUSTRALIA<br />
ORION CORP, FINLAND<br />
BRISTOL-MYERS SQUIBB<br />
COMPANY, UNITED<br />
STATES<br />
MISATO PLANT OF EISAI<br />
CO, JAPAN<br />
ASTRAZENECA AB,<br />
SWEDEN<br />
DELPHARM LILLE S.A.S.,<br />
FRANCE<br />
PFIZER ITALIA S.R.L.,<br />
ITALY<br />
MERCK & CO INC,<br />
UNITED STATES<br />
PFIZER ITALIA S.R.L.,<br />
ITALY<br />
SCHERING PLOUGH<br />
PRODUCTS, UNITED<br />
STATES<br />
NOVARTIS<br />
FARMACEUTICA S.A.,
Bil.<br />
LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES<br />
(NOVEMBER 2012)<br />
TEST PRODUCTS<br />
(Pharmaceutical<br />
name)<br />
Trade Mark/Registration No./<br />
Reference No.<br />
95. Famotidine PEPCIDINE 20MG TABLET<br />
MAL19900506A<br />
<strong>Comparator</strong> <strong>Products</strong><br />
96. Fen<strong>of</strong>ibrate LIPANTHYL SUPRA 160MGFILM-<br />
COATED TABLET<br />
MAL20020488A<br />
LIPANTHYL PENTA 145 FILM<br />
COATED TABLET<br />
97. Fex<strong>of</strong>enadine<br />
hydrochloride<br />
MAL10053648A<br />
LIPANTHYL MICRO CAPSULE<br />
MAL19983968A<br />
LIPANTHYL MICRO 267 CAPSULE<br />
MAL20014486A<br />
TELFAST 30MG TABLET<br />
MAL20031923A<br />
TELFAST 60MG TABLET<br />
MAL20051395AR<br />
TELFAST 120MG<br />
MAL20000714A<br />
98. Finasteride<br />
TELFAST 180MG TABLET<br />
MAL20000715A<br />
PROPECIA TABLET<br />
MAL19992040AR<br />
PROSCAR 5MG TABLET<br />
MAL19985910AR<br />
99. Flavoxate URISPAS 200 TABLET<br />
MAL20033669A<br />
100. Flecainide TAMBOCOR TABLET 100MG<br />
MAL19871528AR<br />
101. Flucloxacillin STAPHLEX 250 CAPSULE<br />
MAL19940106A<br />
Manufacturer<br />
SPAIN<br />
MERCK SHARP & DOHME<br />
(AUSTRALIA) PTY LTD,<br />
AUSTRALIA<br />
RECIPHARM FONTAINE,<br />
FRANCE<br />
LABS FOURNIER SA,<br />
FRANCE<br />
AVENTIS PHARMA INC,<br />
UNITED STATES<br />
HOECHST MARION<br />
ROUSSEL INC, UNITED<br />
STATES<br />
SANOFI-AVENTIS U.S.<br />
LLC, UNITED STATES<br />
MERCK SHARP & DOHME<br />
QUIMICA DE PUERTO<br />
RICO LTD, UNITED<br />
STATES<br />
RECORDATI INDUSTRIA<br />
CHIMICA E<br />
FARMACEUTICA S.P.A.,<br />
ITALY<br />
3M HEALTHCARE LTD,<br />
UNITED KINGDOM<br />
PACIFIC PHARM LTD,<br />
NEW ZEALAND<br />
STAPHLEX 500 CAPSULE<br />
PACIFIC PHARM LTD,<br />
MAL19940107A<br />
NEW ZEALAND<br />
102. Fludarabine FLUDARA 10MG FILM COATED BAYER SCHERING<br />
TABLETS<br />
MAL05051075AC<br />
PHARMA AG, GERMANY<br />
103. Fludrocortisone FLORINEF 0.1MG TABLET BRISTOL-MYERS SQUIBB
LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES<br />
(NOVEMBER 2012)<br />
TEST PRODUCTS<br />
<strong>Comparator</strong> <strong>Products</strong><br />
Bil. (Pharmaceutical<br />
name)<br />
Trade Mark/Registration No./<br />
Reference No.<br />
Manufacturer<br />
acetate MAL19990027A PTY LTD, AUSTRALIA<br />
104. Flunarizine<br />
SIBELIUM CAPSULE 5MG<br />
JANSSEN-CILAG S.P.A.,<br />
hydrochloride MAL19880179AR<br />
SIBELIUM TABLET 5 MG<br />
MAL09100238A<br />
ITALY<br />
105. Fluoxymesterone HALOTESTIN TABLETS 5MG PHARMACIA & UPJOHN<br />
(BELGIUM)<br />
MAL19920022A<br />
S.A., BELGIUM<br />
106. Flupentixol<br />
FLUANXOL TABLET 0.5MG H.LUNDBECK A/S,<br />
dihydrochloride MAL19890543A<br />
FLUANXOL TABLETS 3MG<br />
MAL19980544A<br />
FLUANXOL TABLETS 1MG<br />
MAL19900451A<br />
DENMARK<br />
107. Flurazepam DALMADORM 15MG CAPSULES LABIANA<br />
Monohydrochloride MAL07050892AC<br />
PHARMACEUTICALS SL,<br />
SPAIN<br />
108. Flurbipr<strong>of</strong>en FROBEN TABLET 50MG<br />
THE BOOTS COMPANY<br />
MAL19861117A<br />
PLC, UNITED KINGDOM<br />
109. Fosinopril sodium MONOPRIL TABLET 10MG PT BRISTOL-MYERS<br />
MAL19992695AS<br />
SQUIBB INDONESIA TBK<br />
MONOPRIL TABLET 10MG BRISTOL-MYERS SQUIBB<br />
MAL19950242A<br />
MONOPRIL TABLET 20MG<br />
MAL19950243A<br />
PTY LTD, AUSTRALIA<br />
110. Gabapentin NEURONTIN 100MG CAPSULE PFIZER<br />
MAL06071076A<br />
MANUFACTURING<br />
NEURONTIN 300MG CAPSULE DEUTSCHLAND GMBH,<br />
MAL19984786AS<br />
NEURONTIN 400MG CAPSULE<br />
MAL19984785AS<br />
GERMANY<br />
NEURONTIN 300MG CAPSULE PFIZER<br />
MAL19962169A<br />
PHARMACEUTICALS LLC,<br />
NEURONTIN 400MG CAPSULE<br />
MAL19962170A<br />
NEURONTIN TABLET 600MG<br />
MAL20031747A<br />
NEURONTIN TABLET 800MG<br />
MAL20031748A<br />
UNITED STATES<br />
111. Galantamine REMINYL TABLET 4MG<br />
JANSSEN CILAG SPA,<br />
hydrobromide MAL20020123A<br />
REMINYL TABLET 8MG<br />
ITALY
LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES<br />
(NOVEMBER 2012)<br />
TEST PRODUCTS<br />
<strong>Comparator</strong> <strong>Products</strong><br />
Bil. (Pharmaceutical<br />
name)<br />
Trade Mark/Registration No./<br />
Reference No.<br />
MAL20020124A<br />
REMINYL TABLET 12MG<br />
MAL20020125A<br />
Manufacturer<br />
112. Ganciclovir CYMEVENE CAPSULE 250MG ROCHE PRODUCTS LTD,<br />
MAL19993019AR<br />
UNITED KINGDOM<br />
CYMEVENE HARD-GELATIN SYNTEX PUERTO RICO<br />
CAPSULE 250MG<br />
MAL19970079A<br />
INC, UNITED STATES<br />
113. Gemfibrozil LOPID CAPSULE 300MG<br />
PARKE DAVIS PTY LTD,<br />
MAL19990998A<br />
LOPID 600MG TABLET<br />
MAL19900442AR<br />
LOPID 600MG TABLET<br />
MAL19984784AS<br />
AUSTRALIA<br />
LOPID 450MG TABLET<br />
GOEDECKE A.G, WEST<br />
MAL19921617ARS<br />
GERMANY<br />
This product can be obtained from Argentina, Austria, Brazil,<br />
Switzerland, Chile, Germany, Denmark, Spain, France, United<br />
Kingdom, Greece, Hong Kong, Indonesia, India, Ireland, Italy,<br />
Mexico, Netherlands, Norway, Peru, Portugal, Philippines, Sweden,<br />
Thailand, Turkey, Taiwan, United States<br />
114. Gestrinone DIMETRIOSE CAPSULE<br />
ROUSSEL LABS LTD,<br />
MAL19940494A<br />
UNITED KINGDOM<br />
115. Glipizide MINIDIAB 5MG TABLET<br />
PFIZER ITALIA S.R.L.,<br />
MAL19913361A<br />
ITALY<br />
116. Granisetron KYTRIL TABLET 1MG<br />
F.HOFFMANN-LA ROCHE<br />
hydrochloride MAL19940574A<br />
LTD, SWITZERLAND<br />
117. Hyoscine<br />
BUSCOPAN TABLET 10MG DELPHARM REIMS,<br />
butylbromide MAL09051577A<br />
FRANCE<br />
118. Hydroxycarbamide HYDREA CAPSULE 500MG, BRISTOL MYERS SQUIBB<br />
MAL19962497A<br />
US<br />
HYDREA CAPSULE 500MG, BRISTOL MYERS SQUIBB<br />
MAL19993027A<br />
S.R.L, ITALY<br />
119. Hydroxyurea/ HYDREA CAPSULE 500MG, BRISTOL MYERS SQUIBB<br />
Hydroxycarbamide MAL19962497A<br />
US<br />
HYDREA CAPSULE 500MG, BRISTOL MYERS SQUIBB<br />
MAL19993027A<br />
S.R.L, ITALY<br />
120. Hydrochlorothiazide DICHLOTRIDE TABLET 25MG, MERCK SHARP & DOHME<br />
MAL19870271AR DICHLOTRIDE<br />
TABLET 50MG, MAL19870201AR<br />
UNITED KINGDOM<br />
DICHLOTRIDE 25MG TABLET, MERCK SHARP & DOHME<br />
MAL19940018AS DICHLOTRIDE (AUSTRALIA) PTY LTD,
LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES<br />
(NOVEMBER 2012)<br />
TEST PRODUCTS<br />
<strong>Comparator</strong> <strong>Products</strong><br />
Bil. (Pharmaceutical<br />
name)<br />
Trade Mark/Registration No./<br />
Reference No.<br />
Manufacturer<br />
50MG TABLET, MAL19940019AS AUSTRALIA<br />
121. Ibandronic acid BONDRONAT FILM-COATED F.HOFFMANN-LA ROCHE<br />
TABLET 50 MG<br />
MAL20071698A<br />
BONVIVA FILM-COATED<br />
TABLETS 150 MG<br />
MAL20071629A<br />
LTD, SWITZERLAND<br />
122. Imatinib mesylate GLIVEC 50MG CAPSULES<br />
MAL20020355A<br />
GLIVEC 100MG CAPSULES<br />
MAL20020356A<br />
GLIVEC TABLET 100MG<br />
MAL06011679A<br />
GLIVEC TABLET 400MG<br />
123. Imidapril<br />
hydrochloride<br />
MAL06011681A<br />
TANATRIL 2.5MG TABLET<br />
MAL20034616A<br />
TANATRIL 5MG TABLET<br />
MAL20034617A<br />
TANATRIL 10MG TABLET<br />
MAL20034618A<br />
124. Indapamide NATRILIX TABLET<br />
MAL19972491A<br />
NATRILIX TABLET 0.0025G<br />
MAL19870270AR<br />
125. Indomethacin INDOCID CAPSULE 25MG<br />
MAL19930412AS<br />
INDOCID CAPSULE 25MG<br />
MAL19861080A<br />
126. Isosorbide Dinitrate ISORDIL ORAL TABLET 10MG<br />
MAL19871489A<br />
ISORDIL SUBLINGUAL TABLET<br />
5MG<br />
PBKD871488A<br />
127. Isotretinoin ROACCUTANE ROCHE CAPSULE<br />
20MG<br />
PBKD861795A<br />
NOVARTIS PHARMA<br />
STEIN AG, SWITZERLAND<br />
PT TANABE INDONESIA,<br />
INDONESIA<br />
LES LABS SERVIER<br />
INDUSTRIE, FRANCE<br />
MERCK SHARP & DOHME<br />
(AUSTRALIA) PTY LTD<br />
MERCK SHARP & DOHME<br />
INT, UNITED STATES<br />
WYETH CANADA<br />
WYETH CANADA<br />
F. HOFFMAN-LA ROCHE,<br />
SWITZERLAND
Bil.<br />
LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES<br />
(NOVEMBER 2012)<br />
TEST PRODUCTS<br />
(Pharmaceutical<br />
name)<br />
<strong>Comparator</strong> <strong>Products</strong><br />
Trade Mark/Registration No./<br />
Reference No.<br />
ROACCUTANE ROCHE CAPSULE<br />
10MG<br />
PBKD861794A<br />
ROACCUTANE CAPSULE 20MG<br />
MAL19991721AC<br />
ROACCUTANE CAPSULE 10MG<br />
MAL19991720A<br />
128. Ketotifen fumarate ZADITEN 1MG TABLET<br />
MAL20000272A<br />
129. Labetalol TRANDATE TABLET 100MG,<br />
MAL19870059A<br />
130. Lansoprazole PREVACID 30MG CAPSULE<br />
MAL19961284AR<br />
131. Leflunomide ARAVA 10MG TABLET<br />
MAL20001528A<br />
ARAVA 20MG TABLET<br />
MAL20001527A<br />
ARAVA TABLET 100MG<br />
132. Levamisole<br />
hydrochloride<br />
MAL20001529A<br />
ERGAMISOL TABLET 50MG<br />
MAL19990537A<br />
133. Levetiracetam KEPPRA 250MG FILM COATED<br />
TABLET<br />
MAL20031725A<br />
KEPPRA 500MG FILM COATED<br />
TABLET<br />
MAL20031726A<br />
KEPPRA 1000MG FILM COATED<br />
TABLET<br />
134. Levocetirizine<br />
dihydrochloride<br />
MAL20031727A<br />
XYZAL 5MG FILM COATED<br />
TABLET<br />
MAL20051323AR<br />
135. Levonorgestrel POSTINOR-2 TABLET 0.75MG<br />
MAL19872263AR<br />
Manufacturer<br />
F. HOFFMAN-LA ROCHE,<br />
SWITZERLAND<br />
R. P. SCHERER GMBH,<br />
GERMANY<br />
NOVARTIS PHARM UK<br />
LTD, UNITED KINGDOM<br />
GLAXOSMITHKLINE<br />
AUSTRALIA PTY LTD,<br />
AUSTRALIA<br />
TAKEDA<br />
PHARMACEUTICAL<br />
COMPANY LIMITED,<br />
JAPAN<br />
SANOFI WINTHROP<br />
INDUSTRIE, FRANCE<br />
JANSSEN<br />
PHARMACEUTICA N.V.,<br />
BELGIUM<br />
UCB S.A. SECTOR<br />
PHARMA, BELGIUM<br />
UCB FARCHIM S.A.,<br />
SWITZERLAND<br />
GEDEON RICHTER PLC,<br />
HUNGARY
LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES<br />
(NOVEMBER 2012)<br />
TEST PRODUCTS<br />
<strong>Comparator</strong> <strong>Products</strong><br />
Bil. (Pharmaceutical<br />
name)<br />
Trade Mark/Registration No./<br />
Reference No.<br />
Manufacturer<br />
136. Levothyroxine OROXINE 100MCG TABLET ASPEN BAD OLDESLOE<br />
sodium<br />
MAL06071058A<br />
OROXINE 50MCG TABLET<br />
MAL06071059A<br />
GMBH, GERMANY<br />
137. Linezolid ZYVOX 400MG TABLETS<br />
PFIZER<br />
MAL20020873AR<br />
PHARMACEUTICALS LLC,<br />
ZYVOX 600MG TABLETS<br />
MAL20020874AR<br />
PUERTO RICO<br />
138. Lomefloxacin MAXAQUIN 400MG TABLET SEARLE DE MEXICO,<br />
hydrochloride MAL19940539A<br />
MEXICO<br />
MAXAQUIN 400MG TABLET MONSANTO FRANCE SA,<br />
MAL19940540AS<br />
FRANCE<br />
139. Lomustine CEENU CAPSULE 40MG<br />
BRISTOL-MYERS SQUIBB<br />
MAL19991719A<br />
S.R.L., ITALY<br />
140. Loperamide IMODIUM CAPSULE 2MG<br />
MAL19871473AR<br />
JANSSEN CILAG, FRANCE<br />
141. Mebeverine DUSPATALIN TABLET 100MG ABBOTT BIOLOGICALS<br />
MAL19920644A<br />
B.V., NETHERLAND<br />
DUSPATALIN TABLET 135MG ABBOTT HEALTHCARE<br />
MAL19940428A<br />
SAS, FRANCE<br />
142. Meclozine ANCOLAN TABLET 25MG<br />
GLAXOSMITHKLINE<br />
MAL19871913A<br />
PHARMACEUTICAL SDN<br />
BHD, MALAYSIA<br />
143. Medroxyprogesteron FARLUTAL TABLET 100MG PFIZER ITALIA S.R.L.,<br />
e acetate<br />
MAL19991379A<br />
FARLUTAL TABLET 500MG<br />
MAL19991380A<br />
ITALY<br />
PROVERA TABLET 5MG<br />
PHARMACIA & UPJOHN<br />
MAL19872113A<br />
CO, UNITED STATES<br />
PROVERA 10MG TABLET<br />
PFIZER<br />
MAL20000997A<br />
PHARMACEUTICAL LLC,<br />
PROVERA 5MG TABLET<br />
MAL06051306A<br />
PUERTO RICO<br />
144. Mefenamic acid PONSTAN TABLET 500MG<br />
MAL19990598AS<br />
PT PFIZER (INDONESIA)<br />
PONSTAN CAPSULES<br />
PFIZER PHARM LTD,<br />
MAL19985093A<br />
CHINA<br />
This product can be obtained from Hong Kong and New Zealand<br />
(Information obtained via an email dated 7 th September 2012 from<br />
Pfizer, Malaysia)<br />
145. Mefloquine<br />
LARIAM TABLET 250MG<br />
F.HOFFMAN-LA ROCHE,<br />
hydrochloride MAL19921123A<br />
SWITZERLAND
LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES<br />
(NOVEMBER 2012)<br />
<strong>Comparator</strong> <strong>Products</strong><br />
Bil.<br />
TEST PRODUCTS<br />
(Pharmaceutical<br />
name)<br />
Trade Mark/Registration No./<br />
Reference No.<br />
146. Megestrol acetate MEGACE TABLET 160MG<br />
MAL19962089A<br />
MEGACE TABLET 40MG<br />
MAL19962090A<br />
147. Melphalan ALKERAN TABLETS 2MG<br />
MAL07101257AC<br />
148. Memantine<br />
EBIXA FILM-COATEDTABLET<br />
hydrochloride 10MG<br />
MAL20061488ACR<br />
EBIXA FILM-COATED TABLET 20<br />
MG<br />
MAL10120014ACR<br />
149. Mequitazine PRIMALAN TABLET 5MG<br />
MAL19871736A<br />
150. Mercaptopurine PURI-NETHOL TABLET 50MG<br />
MAL19861668A<br />
151. Mesterolone PROVIRONUM TABLET 25MG<br />
MAL09122025AC<br />
152. Methimazole TAPAZOLE (T-1765) TABLET 5MG<br />
1986042151A<br />
153. Methoxsalen OXSORALEN-ULTRA CAPSULES<br />
10MG<br />
MAL19920052A<br />
MELADININE TABLET 10MG<br />
MAL05090015AC<br />
154. Methyldopa ALDOMET-M 125MG TABLET<br />
MAL19920191A<br />
ALDOMET 250MG TABLET<br />
(AUSTRALIA)<br />
MAL19920190A<br />
155. Methylphenidate RITALIN TABLET 10MG<br />
hydrochloride MAL19910002A<br />
156. Methylprednisolone MEDROL TABLET 4MG<br />
MAL19990558A<br />
MEDROL TABLET 16MG<br />
MAL19990559A<br />
Manufacturer<br />
BRISTOL-MYERS SQUIBB<br />
AUSTRALIA PTY LTD,<br />
AUSTRALIA<br />
HAUPT PHARMA<br />
REGENSBURG GMBH,<br />
GERMANY<br />
EXCELLA GMBH,<br />
GERMANY<br />
ROTTENDORF PHARMA<br />
GMBH, GERMANY<br />
MAY & BAKER LTD,<br />
UNITED KINGDOM<br />
THE WELLCOME<br />
FOUNDATION LTD,<br />
UNITED KINGDOM<br />
SCHERING DA BRASIL<br />
QUIMICAE<br />
FARMACEUTICA LTDA.,<br />
BRAZIL<br />
ELI LILLY &C0 (TAIWAN)<br />
INC, TAIWAN<br />
ICN PHARM INC, UNITED<br />
STATES<br />
LABOBORATOIRES<br />
MACORS, FRANCE<br />
MERCK SHARP & DOHME<br />
(AUSTRALIA) PTY LTD,<br />
AUSTRALIA<br />
NOVARTIS<br />
FARMACEUTICA S.A.,<br />
SPAIN<br />
PHARMACIA & UPJOHN<br />
CO, UNITED STATES
LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES<br />
(NOVEMBER 2012)<br />
TEST PRODUCTS<br />
<strong>Comparator</strong> <strong>Products</strong><br />
Bil. (Pharmaceutical<br />
name)<br />
Trade Mark/Registration No./<br />
Reference No.<br />
Manufacturer<br />
157. Metoclopramide MAXOLON TABLET 10MG BEECHAM PHARM,<br />
hydrochloride MAL19921400A<br />
UNITED KINGDOM<br />
This product can be obtained from South Africa and Pakistan.<br />
(Information obtained via email dated 26 th Sept 2012 from GSK,<br />
Malaysia)<br />
158. Mianserin<br />
TOLVON TABLET 10MG<br />
N.V. ORGANON,<br />
hydrochloride MAL19900637A<br />
TOLVON TABLET 30MG<br />
MAL19900638A<br />
TOLVON TABLET 60MG<br />
MAL19900639A<br />
NETHERLANDS<br />
159. Midazolam DORMICUM ROCHE TABLET 7.5 F.HOFFMAN-LA ROCHE,<br />
MG<br />
MAL19890299A<br />
DORMICUM FILM-COATED<br />
TABLET 15MG<br />
MAL19920037A<br />
SWITZERLAND<br />
160. Miglitol DIASTABOL 50MG<br />
MAL19990973A<br />
DIASTABOL 100MG<br />
MAL19990974A<br />
BAYER AG, GERMANY<br />
161. Milnacipran IXEL 25MG HARD CAPSULES PIERRE FABRE<br />
hydrochloride MAL20061611A<br />
MEDICAMENT<br />
IXEL 50MG HARD CAPSULES<br />
MAL20061612A<br />
PRODUCTION, FRANCE<br />
162. Minoxidil LONITEN 5MG TABLETS<br />
GLOBAL PHARM LTD,<br />
MAL20014500AR<br />
LONITEN 10MG TABLETS<br />
MAL20014501AR<br />
CANADA<br />
LONITEN TABLET 5MG<br />
UPJOHN LTD, UNITED<br />
MAL19861624A<br />
LONITEN TABLET 10MG<br />
MAL19861623A<br />
KINGDOM<br />
163. Misoprostol CYTOTEC TABLET 200MCG PIRAMAL HEALTHCARE<br />
MAL19890225AR<br />
UK LIMITED, UNITED<br />
KINGDOM<br />
164. Mizolastin MIZOLLEN TABLET 10MG SANOFI WINTHROP<br />
MAL20001215A<br />
INDUSTRIE, FRANCE<br />
165. Moclobemide AURORIX FILM-COATED TABLET F.HOFFMANN-LA ROCHE<br />
150MG<br />
MAL19910811A<br />
AURORIX FILM-COATED TABLET<br />
LTD, SWITZERLAND
LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES<br />
(NOVEMBER 2012)<br />
TEST PRODUCTS<br />
<strong>Comparator</strong> <strong>Products</strong><br />
Bil. (Pharmaceutical<br />
name)<br />
Trade Mark/Registration No./<br />
Reference No.<br />
300MG<br />
MAL19987972A<br />
Manufacturer<br />
166. Montelukast sodium SINGULAIR TABLET 10MG MERCK SHARP & DOHME<br />
MAL19990957AR<br />
LTD, UNITED KINGDOM<br />
167. Morphine sulphate KAPANOL CAPSULES 20MG F.H. FAULDING & CO LTD,<br />
MAL19984000AR<br />
KAPANOL CAPSULES 50MG<br />
MAL19984001AR<br />
KAPANOL CAPSULES 100MG<br />
MAL19984002AR<br />
AUSTRALIA<br />
168. Moxifloxacin AVELOX TABLET<br />
BAYER SCHERING<br />
hydrochloride MAL20012664A<br />
PHARMA AG,<br />
LEVERKUSEN, GERMANY<br />
169. Moxonidine PHYSIOTENS 0.2MG TABLET ABBOTT HEALTHCARE<br />
MAL20033335AR<br />
PHYSIOTENS 0.3MG TABLET<br />
MAL20033336AR<br />
PHYSIOTENS 0.4MG TABLET<br />
MAL20033337AR<br />
SAS, FRANCE<br />
170. Naltrexone<br />
REVIA TABLET 50MG<br />
DUPONT PHARM<br />
hydrochloride MAL20013367A<br />
COMPANY, UNITED<br />
STATES<br />
171. Nateglinide STARLIX 60MG TABLET<br />
NOVARTIS FARMA S.P.A.,<br />
MAL20014476A<br />
STARLIX 120MG TABLET<br />
MAL20014477A<br />
ITALY<br />
172. Nebivolol NEBILET TABLET<br />
BERLIN-CHEMIE AG,<br />
MAL20041163A<br />
GERMANY<br />
173. Neostigmine bromide PROSTIGMIN ROCHE TABLET ROCHE PRODUCTS LTD,<br />
15MG<br />
MAL19871818A<br />
UNITED KINGDOM<br />
174. Nimodipine NIMOTOP TABLET 30MG<br />
BAYER SCHERING<br />
MAL19940001A<br />
PHARMA AG,<br />
LEVERKUSEN, GERMANY<br />
175. Nisoldipine SYSCOR CC 10MG TABLET BAYER AG, WEST<br />
MAL20000264AC<br />
SYSCOR CC TABLET 20MG<br />
MAL20000265AC<br />
SYSCOR CC TABLET 30MG<br />
MAL20000266AC<br />
SYSCOR CC TABLET 40MG<br />
MAL20000267AC<br />
GERMANY
LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES<br />
(NOVEMBER 2012)<br />
TEST PRODUCTS<br />
<strong>Comparator</strong> <strong>Products</strong><br />
Bil. (Pharmaceutical<br />
name)<br />
Trade Mark/Registration No./<br />
Reference No.<br />
Manufacturer<br />
176. Nizatidine<br />
177. Norethisterone<br />
PU 3144 AXID CAPSULE 150MG<br />
MAL19950508AC<br />
LILLY S.A., SPAIN<br />
PRIMOLUT-N TABLET 5MG ZUELLIG PHARMA SDN<br />
178. Norgestrel<br />
MAL19900564A<br />
BHD<br />
POSTINOR-2 TABLET 0.75MG, GEDEON RICHTER PLC,<br />
MAL19872263AR<br />
HUNGARY<br />
179. Nystatin MYCOSTATIN ORAL TABLET<br />
500000 IU<br />
180. Ondansetron<br />
hydrochloride<br />
dihydrate<br />
MAL19921327A<br />
ZOFRAN TABLET 4MG<br />
MAL19950007ACR<br />
ZOFRAN TABLET 8MG<br />
MAL19950013ACR<br />
181. Orlistat XENICAL CAPSULE 120MG<br />
MAL19992994A<br />
XENICAL CAPSULE 120 MG<br />
MAL05032548A<br />
182. Orphenadrine citrate NORFLEX TABLET 100MG<br />
MAL19861502A<br />
183. Oxcarbazepine TRILEPTAL 600MG TABLETS<br />
MAL20021156A<br />
TRILEPTAL 600 MG FILM-COATED<br />
TABLET<br />
MAL07050038AS<br />
184. Oxybutynin DRIPTANE TABLET 5MG<br />
hydrochloride MAL19991351AR<br />
185. Oxycodone<br />
hydrochloride<br />
OXYNORM 5MG CAPSULES<br />
MAL10070560AC<br />
OXYNORM 10MG CAPSULES<br />
MAL10070561AC<br />
OXYNORM 20MG CAPSULES<br />
MAL10070562AC<br />
BRISTOL-MYERS SQUIBB<br />
PTY LTD, AUSTRALIA<br />
ASPEN BAD OLDESLOE<br />
GMBH, GERMANY<br />
F.HOFFMANN,LA ROCHE<br />
LTD, SWITZERLAND<br />
ROCHE S.P.A., ITALY<br />
INOVA<br />
PHARMACEUTICALS<br />
(AUSTRALIA) PTY LTD,<br />
AUSTRALIA<br />
NOVARTIS PHARMA<br />
STEIN AG, SWITZERLAND<br />
NOVARTIS FARMA S.P.A.,<br />
ITALY<br />
LABS FOURNIER SA,<br />
FRANCE<br />
BARD<br />
PHARMACEUTICALS<br />
LIMITED, UNITED<br />
KINGDOM<br />
186. Oxymetholone ANAPOLON 50 TABLET<br />
SYNTEX INCORPORATED,<br />
MAL19870679A<br />
CANADA<br />
ANAPOLON 50 TABLET SYNTEX PHARM LTD,
LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES<br />
(NOVEMBER 2012)<br />
TEST PRODUCTS<br />
<strong>Comparator</strong> <strong>Products</strong><br />
Bil. (Pharmaceutical<br />
name)<br />
Trade Mark/Registration No./<br />
Reference No.<br />
Manufacturer<br />
MAL19870678A UNITED KINGDOM<br />
187. Pantoprazole CONTROLOC 20MG TABLET NYCOMED GMBH,<br />
MAL20032151A<br />
CONTROLOC 40MG TABLET<br />
MAL19972093AR<br />
GERMANY<br />
188. Paricalcitol ZEMPLAR CAPSULES 1 MCG CATALENT PHARMA<br />
MAL20071708AC<br />
SOLUTIONS, LLC, UNITED<br />
ZEMPLAR CAPSULES 2 MCG<br />
MAL20071709AC<br />
ZEMPLAR CAPSULES 4 MCG<br />
MAL20071710AC<br />
STATES<br />
189. Penicillamine ARTAMIN CAPSULE 250MG HAUPT PHARMA BERLIN<br />
MAL20021153AC<br />
GMBH, GERMANY<br />
190. Pentoxifylline TRENTAL 400 TABLET<br />
SANOFI-AVENTIS DE<br />
MAL19990996A<br />
MEXICO SA DE CV<br />
191. Phenobarbitone GARDENAL TABLET 30MG MAY & BAKER (INDIA)<br />
MAL19871467A<br />
LTD, INDIA<br />
192. Phentermine DUROMINE CAPSULE 15MG INOVA<br />
MAL19871769AR<br />
PHARMACEUTICALS<br />
(AUSTRALIA) PTY LTD,<br />
AUSTRALIA<br />
DUROMINE CAPSULE 30MG<br />
MAL19871774AR<br />
INOVA<br />
PHARMACEUTICALS<br />
(AUSTRALIA) PTY LTD,<br />
AUSTRALIA<br />
MAY & BAKER LTD,<br />
193. Phthalylsulphathiazo THALAZOLE TABLET 500MG<br />
le<br />
UNITED KINGDOM<br />
194. Pindolol VISKEN TABLET 5MG<br />
NOVARTIS PHARMA AG,<br />
PBKD870587A<br />
VISKEN TABLET 10MG<br />
PBKD870074A<br />
SWITZERLAND<br />
195. Pipemidic acid URIXIN FILMTAB TABLET ABBOTT LABS,<br />
MAL19910050A<br />
URIXIN FILMTAB 400MG<br />
MAL19871869A<br />
PHILIPPINES<br />
196. Piracetam NOOTROPIL TABLET 800 MG UCB S.A. - SECTEUR<br />
MAL07021408A<br />
NOOTROPIL TABLET 1200 MG<br />
MAL07021409A<br />
PHARMA, BELGIUM<br />
197. Pizotifen malate SANDOMIGRAN TABLET 0.5MG NOVARTIS FARMA S.P.A.,
LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES<br />
(NOVEMBER 2012)<br />
TEST PRODUCTS<br />
<strong>Comparator</strong> <strong>Products</strong><br />
Bil. (Pharmaceutical<br />
name)<br />
Trade Mark/Registration No./<br />
Reference No.<br />
Manufacturer<br />
MAL19860378A ITALY<br />
198. Pravastatin sodium PRAVACHOL TABLET 10MG BRISTOL-MYERS SQUIBB<br />
MAL20032161A<br />
PRAVACHOL TABLET 40MG<br />
MAL19991374A<br />
PTY LTD, AUSTRALIA<br />
199. Prazosin MINIPRESS TABLET 1MG<br />
PFIZER AUSTRALIA PTY.<br />
MAL19870096A<br />
MINIPRESS TABLET 2MG<br />
MAL19870098A<br />
MINIPRESS TABLET 5MG<br />
MAL19870100A<br />
LTD.<br />
MINIPRESS TABLET 1MG<br />
PHARMANIAGA<br />
MAL19930148AC<br />
MANUFACTURING<br />
MINIPRESS TABLET 2MG<br />
MAL19930149AC<br />
MINIPRESS TABLET 5MG<br />
MAL19930150AC<br />
BERHAD<br />
200. Primaquine PRIMAQUINE TABLET<br />
ASTRAZENECA UK<br />
phosphate<br />
MAL19911192X<br />
LIMITED, UNITED<br />
KINGDOM<br />
201. Primidone MYSOLINE 250MG TABLETS UNITED KINGDOM<br />
202. Probenecid BENEMID TABLET 0.5G<br />
MERCK SHARP & DOHME<br />
MAL19870994A<br />
INT, UNITED STATES<br />
203. Procaterol<br />
MEPTIN TABLET 0.05MG<br />
OTSUKA<br />
hydrochloride MAL19890453AC<br />
PHARMACEUTICAL CO.,<br />
LTD, JAPAN<br />
204. Prochlorperazine STEMETIL TABLET 5MG<br />
MAY & BAKER LTD,<br />
maleate<br />
MAL19861398A<br />
UNITED KINGDOM<br />
This product can be obtained from Bangladesh, Denmark, Hong<br />
Kong, Jamaica, Malta, Mauritius, Namibia, Pakistan, Thailand,<br />
Ireland, South Africa and United Kingdom.<br />
(Information obtained via an email dated 21 st Sept 2012 from San<strong>of</strong>i<br />
Aventis Malaysia)<br />
205. Progesterone UTROGESTAN CAPSULE 100MG BESINS<br />
MAL19971796A<br />
MANUFACTURING<br />
BELGIUM, BELGIUM<br />
206. Proguanil<br />
hydrochloride<br />
PALUDRINE TABLETS 100MG<br />
PBKD911193A<br />
ASTRAZENECA UK<br />
LIMITED, UNITED<br />
KINGDOM
LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES<br />
(NOVEMBER 2012)<br />
TEST PRODUCTS<br />
<strong>Comparator</strong> <strong>Products</strong><br />
Bil. (Pharmaceutical<br />
name)<br />
Trade Mark/Registration No./<br />
Reference No.<br />
Manufacturer<br />
207. Promethazine PHENERGAN TABLET 10MG SANOFI AVENTIS,<br />
PHENERGAN TABLET 25MG UNITED KINGDOM<br />
208. Propafenone RYTMONORM TABLET 150MG ABBOT GMBH & CO. KG,<br />
MAL19880156A<br />
GERMANY<br />
209. Propantheline PRO-BANTHINE TABLET 15MG SEARLE LABS,<br />
PBKD861516A<br />
AUSTRALIA.<br />
PRO-BANTHINE TABLET 15MG G.D. SEARLE & CO,<br />
PBKD861515A<br />
UNITED KINGDOM<br />
210. Propiverine MICTONORM TABLET<br />
APOGEPHA<br />
MAL20061584A<br />
ARZNEIMITTEL GMBH,<br />
GERMANY<br />
211. Propylthiouracil PROPYLTHIOURACIL TABLET EVANS MEDICAL LTD,<br />
B.P. 50MG<br />
UNITED KINGDOM<br />
212. Pseudoephedrine SUDAFED TABLET 60MG,<br />
WELLCOME AUSTRALIA<br />
MAL19870799A<br />
LTD, AUSTRALIA<br />
213. Pyridostigmine MESTINON TABLET 10MG LABIANA<br />
bromide<br />
MAL05090001ACR<br />
PHARMACEUTICALS, SL,<br />
MESTINON DRAGEES 60MG<br />
MAL04112698ACR<br />
SPAIN<br />
214. Repaglinide<br />
BOEHRINGER INGELHEIM<br />
NOVONORM TABLET 0.5MG PHARMA KG, WEST<br />
MAL20001007AC<br />
GERMANY<br />
NOVONORM TABLET 1.0MG BOEHRINGER INGELHEIM<br />
MAL20001008AC<br />
PHARMA GMBH & CO.KG,<br />
NOVONORM TABLET 2.0MG<br />
MAL20001009AC<br />
WEST GERMANY<br />
215. Reserpine SERPASIL TABLET 0.10MG NOVARTIS PHARMA<br />
1986044940A<br />
SERPASIL TABLET 0.25MG<br />
1986044921A<br />
STEIN AG, SWITZERLAND<br />
216. Ribavirin REBETOL CAPSULES 200MG SCHERING-PLOUGH<br />
MAL20001524A<br />
LABO N.V., BELGIUM<br />
COPEGUS FILM-COATED TABLET HOFFMANN-LA ROCHE<br />
200MG<br />
MAL05012334A<br />
INC, UNITED STATES<br />
COPEGUS FILM COATED TABLET<br />
200MG<br />
MAL08051760ACS<br />
PATHEON INC, CANADA<br />
217. Rifabutin MYCOBUTIN 150MG CAPSULES<br />
MAL19960957A<br />
PFIZER ITALIA S.R.L.<br />
218. Riluzole RILUTEK TABLETS 50MG SANOFI WINTHROP
LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES<br />
(NOVEMBER 2012)<br />
TEST PRODUCTS<br />
<strong>Comparator</strong> <strong>Products</strong><br />
Bil. (Pharmaceutical<br />
name)<br />
Trade Mark/Registration No./<br />
Reference No.<br />
Manufacturer<br />
MAL20051294A INDUSTRIE, FRANCE<br />
219. Risedronate sodium ACTONEL FILM-COATED TABLET OSG NORWICH PHARM<br />
5MG<br />
MAL20012657AR<br />
ACTONEL 30MG TABLET<br />
MAL20012656AR<br />
INC, UNITED STATES<br />
ACTONEL 35MG TABLET<br />
NORWICH<br />
MAL20034605AR<br />
PHARMACEUTICALS INC.,<br />
UNITED STATES<br />
220. Rivastigmine EXELON 1.5MG CAPSULES NOVARTIS<br />
hydrogen tartrate MAL19990976A<br />
FARMACEUTICA S.A.,<br />
EXELON 3MG CAPSULES<br />
MAL19990977A<br />
EXELON 4.5MG CAPSULES<br />
MAL19990978A<br />
EXELON 6MG CAPSULES<br />
MAL19990979A<br />
SPAIN<br />
221. Rizatriptan benzoate MAXALT TABLET 5MG<br />
MERCK SHARP & DOHME<br />
MAL20000249AR<br />
MAXALT TABLET 10MG<br />
MAL20000250AR<br />
LTD, UNITED KINGDOM<br />
222. Ropinirole<br />
REQUIP TABLET 0.25MG<br />
SMITHKLINE BEECHAM<br />
hydrochloride MAL19990966A<br />
PHARM, UNITED<br />
REQUIP TABLET 1MG<br />
MAL19990967A<br />
REQUIP TABLET 2MG<br />
MAL19990968A<br />
REQUIP TABLET 5MG<br />
MAL19990969A<br />
KINGDOM<br />
223. Rosiglitazone AVANDIA TABLET 2MG<br />
GLAXO WELLCOME S.A.,<br />
MAL20000007A<br />
AVANDIA TABLET 4MG<br />
MAL20000008A<br />
AVANDIA TABLET 8MG<br />
MAL20000009A<br />
SPAIN<br />
224. Rosuvastatin calcium CRESTOR 10MG TABLET<br />
IPR PHARMACEUTICALS<br />
MAL20041089AR<br />
CRESTOR 20MG TABLET<br />
MAL20051357AR<br />
INC, PUERTO RICO
LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES<br />
(NOVEMBER 2012)<br />
TEST PRODUCTS<br />
<strong>Comparator</strong> <strong>Products</strong><br />
Bil. (Pharmaceutical<br />
name)<br />
Trade Mark/Registration No./<br />
Reference No.<br />
Manufacturer<br />
225. Sildenafil citrate VIAGRA 25MG TABLET<br />
PFIZER INC, UNITED<br />
MAL19990542A<br />
VIAGRA 50MG TABLET<br />
MAL19990543A<br />
VIAGRA 100MG TABLET<br />
MAL19990544A<br />
STATES<br />
VIAGRA 25MG TABLET<br />
PFIZER AUSTRALIA PTY.<br />
MAL20012709AS<br />
VIAGRA 50MG TABLET<br />
MAL20012710AS<br />
VIAGRA 100MG TABLET<br />
MAL20012711AS<br />
LTD., AUSTRALIA<br />
226. Sodium Iodide SODIUM IODIDE (1311) THERAPY GE HEALTHCARE<br />
CAPSU*<br />
LIMITED, UNITED<br />
MAL19930360A<br />
KINGDOM<br />
227. Sodium fusidate FUCIDIN TABLET 250MG (FILM LEO PHARM PRODUCTS,<br />
COATED)<br />
MAL19910821A<br />
DENMARK<br />
228. Sodium rabeprazole PARIET TABLET 10MG<br />
MAL19992540A<br />
PARIET TABLET 20MG<br />
MAL19992541A<br />
EISAI CO LTD, JAPAN<br />
229. Sorafenib tosylate NEXAVAR FILM-COATED BAYER SCHERING<br />
TABLETS 200 MG<br />
PHARMA AG,<br />
MAL20071668A<br />
LEVERKUSEN, GERMANY<br />
230. Sotalol<br />
SOTACOR TABLET 80MG<br />
BRISTOL-MYERS CO LTD,<br />
hydrochloride MAL19930231A<br />
SOTACOR TABLET 160MG<br />
MAL19930232A<br />
UNITED KINGDOM<br />
SOTACOR TABLET 80MG<br />
BRISTOL-MYERS SQUIBB<br />
MAL19940601AS<br />
SOTACOR TABLET 160MG<br />
MAL19940602AS<br />
PTY LTD, AUSTRALIA<br />
231. Spiramycin ROVAMYCINE TABLET 1.5<br />
MILLION IU<br />
MAL19890558A<br />
ROVAMYCINE 3 M.I.U. TABLETS<br />
MAL19962132A<br />
FAMAR LYON, FRANCE<br />
232. Spironolactone ALDACTONE TABLET 100MG SEARLE LABS,<br />
MAL19870236A<br />
AUSTRALIA<br />
233. Sulindac CLINORIL 200MG TABLET MERCK SHARP & DOHME<br />
MAL19950546A<br />
(AUSTRALIA) PTY LTD,
Bil.<br />
LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES<br />
(NOVEMBER 2012)<br />
TEST PRODUCTS<br />
(Pharmaceutical<br />
name)<br />
Trade Mark/Registration No./<br />
Reference No.<br />
<strong>Comparator</strong> <strong>Products</strong><br />
234. Sulodexide VESSEL DUE F 250 LSU CAPSULE<br />
MAL19992679A<br />
235. Sulphasalazine SALAZOPYRIN EN TABLET 500MG<br />
MAL19950470A<br />
236. Sultamicillin tosylate UNASYN TABLET<br />
MAL19910104A<br />
UNASYN ORAL TABLET 375MG<br />
MAL20020026ACS<br />
237. Sumatriptan<br />
succinate<br />
IMIGRAN TABLET 50MG<br />
MAL19973576AR<br />
IMIGRAN TABLET 100MG<br />
MAL19950008A<br />
238. Tegafur FUTRAFUL CAPSULE 200MG<br />
MAL19861648A<br />
239. Telmisartan MICARDIS TABLET 20MG<br />
MAL20014487A<br />
MICARDIS TABLET 40MG<br />
MAL19992673A<br />
MICARDIS TABLET 80MG<br />
MAL19992674A<br />
240. Temozolomide TEMODAL CAPSULES 5MG<br />
MAL07082878ACR<br />
TEMODAL CAPSULES 5 MG<br />
MAL06071048ACRS<br />
TEMODAL CAPSULES 20MG<br />
MAL07082880ACR<br />
TEMODAL CAPSULES 20 MG<br />
MAL06071049ACRS<br />
TEMODAL CAPSULES 100MG<br />
MAL07082881ACR<br />
TEMODAL CAPSULES 250 MG<br />
MAL06071051ACRS<br />
TEMODAL CAPSULES 20MG<br />
MAL20032408AR<br />
TEMODAL CAPSULES 100MG<br />
MAL20032409AR<br />
TEMODAL CAPSULES 250MG<br />
MAL20032410AR<br />
Manufacturer<br />
AUSTRALIA<br />
ALFA WASSERMANN<br />
S.P.A., ITALY<br />
KEMWELL AB, SWEDEN<br />
PFIZER JAPAN INC<br />
PHARMANIAGA<br />
MANUFACTURING<br />
BERHAD<br />
GLAXOSMITHKLINE<br />
PHARMACEUTICALS SA,<br />
POLAND<br />
GLAXO WELLCOME<br />
OPERATIONS UK LTD,<br />
UNITED KINGDOM<br />
TAIHO PHARM CO LTD,<br />
JAPAN<br />
BOEHRINGER INGELHEIM<br />
PHARMA GMBH & CO.KG,<br />
WEST GERMANY<br />
ORION CORPORATION,<br />
ORION PHARMA,<br />
FINLAND<br />
INTEGRATED<br />
THERAPEUTICS GROUP<br />
INC, UNITED STATES
LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES<br />
(NOVEMBER 2012)<br />
TEST PRODUCTS<br />
<strong>Comparator</strong> <strong>Products</strong><br />
Bil. (Pharmaceutical<br />
name)<br />
Trade Mark/Registration No./<br />
Reference No.<br />
Manufacturer<br />
241. Tenoxicam TILCOTIL`ROCHE`LACQ-COATED F.HOFFMAN-LA ROCHE,<br />
TAB 20MG<br />
MAL19890224A<br />
SWITZERLAND<br />
242. Terazosin<br />
HYTRIN 1MG TABLET<br />
AESICA QUEENBOROUGH<br />
hydrochloride MAL20014488AC<br />
LIMITED, UNITED<br />
HYTRIN 2MG TABLET<br />
MAL20014489AC<br />
HYTRIN 5MG TABLET<br />
MAL20014490AC<br />
KINGDOM<br />
243. Thioguanine LANVIS TABLETS 40MG<br />
DSM PHARMACEUTICALS<br />
MAL05032537ACR<br />
INC, UNITED STATES<br />
244. Thyroxine sodium ELTROXIN TABLET 0.05 MG GLAXO WELLCOME<br />
MAL19890455A<br />
ELTROXIN TABLET 0.1MG<br />
MAL19890456A<br />
OPERATIONS UK LTD<br />
245. Tibolone LIVIAL TABLET 2.5MG<br />
N.V. ORGANON,<br />
MAL19913394A<br />
NETHERLANDS<br />
246. Tolbutamide RASTINON TABLET 500MG AVENTIS PHARMA<br />
MAL19870403A<br />
DEUTSCHLAND GMBH,<br />
WEST GERMANY<br />
This product can be obtained from Japan, Australia, Hong Kong and<br />
Mexico (Information obtained via an email dated 2 nd Oct 2012 from<br />
San<strong>of</strong>i Aventis, Malaysia)<br />
247. Tolterodine<br />
DETRUSITOL TABLET 2MG PFIZER ITALIA S.R.L.,<br />
l-tartrate<br />
MAL19991686A<br />
ITALY<br />
248. Topotecan<br />
HYCAMTIN 0.25MG HARD GLAXOSMITHKLINE<br />
hydrochloride CAPSULES<br />
MANUFACTURING S.P.A,<br />
MAL20091960A<br />
HYCAMTIN 1 MG HARD<br />
CAPSULES<br />
MAL20091961A<br />
ITALY<br />
249. Tramadol<br />
TRAMAL CAPSULE<br />
GRUNENTHAL GMBH,<br />
hydrochloride MAL19921516A<br />
WEST GERMANY<br />
250. Triazolam SOMESE TABLET 0.25 MG<br />
MAL07050020ACR<br />
SANICO N.V., BELGIUM<br />
251. Triflusal GRENDIS 300MG CAPSULE J. URIACH & CIA,S.A.,<br />
MAL20051420A<br />
SPAIN<br />
252. Trimebutine maleate DEBRIDAT TABLET<br />
JOUVEINAL LABS,<br />
1990040029A<br />
FRANCE<br />
253. Trimetazine VASTAREL COATED TABLET LES LABS SERVIER<br />
hydrochloride 20MG<br />
MAL19870169A<br />
INDUSTRIE, FRANCE
LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES<br />
(NOVEMBER 2012)<br />
TEST PRODUCTS<br />
<strong>Comparator</strong> <strong>Products</strong><br />
Bil. (Pharmaceutical<br />
name)<br />
Trade Mark/Registration No./<br />
Reference No.<br />
Manufacturer<br />
254. Ursodeoxycholic acid URSOFALK CAPSULE 250MG LOSAN PHARMA GMBH,<br />
MAL19990011ACS<br />
GERMANY<br />
255. Vigabatrin SABRIL 500MG TABLET<br />
PATHEON FRANCE S.A.,<br />
MAL19961357A<br />
FRANCE<br />
256. Vinorelbine tartrate NAVELBINE 20MG SOFT CAPSULE PIERRE FABRE<br />
MAL20071635A<br />
MEDICAMENT<br />
NAVELBINE 30MG SOFT CAPSULE<br />
MAL20071636A<br />
PRODUCTION, FRANCE<br />
257. Voriconazole VFEND 50MG TABLET<br />
PFIZER<br />
MAL20040542A<br />
MANUFACTURING<br />
VFEND 200MG TABLET<br />
DEUTSHLAND GMBH,<br />
MAL20040543A<br />
GERMANY<br />
258. Ziprasidone ZELDOX CAPSULE 20MG<br />
PFIZER AUSTRALIA PTY.<br />
hydrochloride MAL20032622A<br />
ZELDOX CAPSULE 40MG<br />
MAL20032623A<br />
ZELDOX CAPSULE 60MG<br />
MAL20032624A<br />
ZELDOX CAPSULE 80MG<br />
MAL20032625A<br />
LTD., AUSTRALIA<br />
259. Z<strong>of</strong>enopril calcium BIFRIL 30<br />
A. MENARINI<br />
MAL20061470A<br />
MANUFACTURING<br />
LOGISTICS AND<br />
SERVICES S.R.L., ITALY<br />
260. Zuclopenthixol CLOPIXOL TABLET 10MG H.LUNDBECK A/S,<br />
MAL19890537A<br />
DENMARK<br />
261. Cycloserine CYCLOSERINE CAPSULE BP<br />
250MG<br />
MAL19900001A<br />
Note:<br />
ELI LILLY AND<br />
COMPANY LIMITED,<br />
UNITED KINGDOM<br />
If you need further clarification, kindly email to mazuwin@bpfk.gov.my and<br />
adilah@bpfk.gov.my<br />
Updated on 22/11/2012
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