BE Test Comparator Products

In order to update the "List of Equivalence Test Comparator Drugs and Generic Drugs that Meet Bioequivalence Criteria" which was published in 2020 and to support ease of application of Equivalence Test regulations for business actors, 3 (three) lists have been prepared as follows:

LIST OF EQUIVALENCE TEST COMPARATOR DRUG REGISTERED IN INDONESIA

No ZAT AKTIF BENTUK SEDIAAN KEKUATAN NAMA DAGANG NIE PRODUSEN PENDAFTAR STATUS
191 Isosorbide Dinitrate Tablet 10 mg Cedocard 10 DKL9104506710B1 Tanggal Terbit 14-02-2018 DARYA VARIA LABORATORIA - INDONESIA DIBAWAH LISENSI TAKEDA NETHERLAND B.V, HOOFDDORP, NETHERLAND DARYA VARIA LABORATORIA - INDONESIA Obat Komparator
192 Isosorbide Dinitrate Tablet Lepas Lambat 20 mg Cedocard Retard DKL8304501114A1 Tanggal terbit 30-08-2018 DARYA VARIA LABORATORIA - INDONESIA DARYA VARIA LABORATORIA - INDONESIA Obat Komparator
193 Isosorbide Mononitrate Tablet Salut Selaput Lepas Lambat 60 mg Imdur DKI1835301414A1 Tanggal Terbit 08-05-2019 ASTRAZENECA PHARMACEUTICAL COMPANY LTD. PYRIDAM FARMA - INDONESIA Obat Komparator
194 Itraconazole Kapsul 100 mg Sporanox DKL1124402501A1 Tanggal Terbit 27-11-2020 TAISHO PHARMACEUTICAL INDONESIA TBK, DEPOK-INDONESIA, DIBAWAH LISENSI JANSSEN PHARMACEUTICA, BEERSE, BELGIUM TAISHO PHARMACEUTICAL INDONESIA TBK - INDONESIA Obat Komparator
195 Ivabradine HCl Tablet Salut Selaput 7,5 mg Coralan DKI1668601317B1 Tanggal Terbit 26-01-2021 LES LABORATORIES SERVIER - FRANCE DARYA VARIA LABORATORIA - INDONESIA Obat Komparator
196 Ivabradine HCl Tablet Salut Selaput 5 mg Coralan DKI1668601317A1 Tanggal Terbit 26-01-2021 LES LABORATORIES SERVIER - FRANCE DARYA VARIA LABORATORIA - INDONESIA Obat Komparator
197 Ketoprofen Suppositoria 100 mg Profenid DKL0121200853A1 Tanggal Terbit 08-03-2020 AVENTIS PHARMA - INDONESIA AVENTIS PHARMA - INDONESIA Obat Komparator
198 Ketoprofen Tablet Salut Enterik 100 mg Profenid E-100 DKL0121200853B1 Tanggal Terbit 03-05-2018 AVENTIS PHARMA - INDONESIA AVENTIS PHARMA - INDONESIA Obat Komparator
199 Lamivudine Tablet Salut Selaput 150 mg 3 TC DKI1833900417A1 Tanggal Terbit 23-10-2018 GLAXO WELLCOME AUSTRALIA PTY LTD, AUSTRALIA GLAXO WELLCOME INDONESIA - INDONESIA Obat Komparator
200 Lamivudine Tablet Salut Selaput 100 mg 3 TC-HBV DKI1733900317A1 Tanggal Terbit 28-08-2018 GLAXO WELLCOME AUSTRALIA PTY LTD, AUSTRALIA GLAXO WELLCOME INDONESIA - INDONESIA Obat Komparator

EQUIVALENCE TEST COMPARATOR DRUG LIST BASED ON SEARCH IN OTHER COUNTRIES

No ZAT AKTIF BENTUK SEDIAAN KEKUATAN NAMA DAGANG NIE PRODUSEN PENDAFTAR STATUS
1 Acetylsalicylic Acid Tablet 300 mg Bayer Aspirin Filipina Bayer Bitterfeld GmbH OT Greppin – Germany] Bayer Phils., Inc -
2 Alendronate sodium Tablet 70 mg Fosamax USA - Merck And Co Inc -
3 Amitriptylline Tablet 10 mg; 25 mg;75 mg Tryptizol Italy - (Merck Sharp & Dohme, Lda. Atau Frosst Iberica, S.A.) Italy -
4 Amitriptylline Tablet 10 mg; 50 mg; 75 mg; 100 mg; 150 mg Amitriptylline Hydrochloride USA - Sandoz Inc -
5 Amoxicillin Kapsul 500 mg Amoxil Singapore Smithkline Beecham Limited (UK); Glaxo Wellcome Production (FR) Glaxosmithkline Pte Ltd -
6 Artemether (kombinasi dengan Lumefantrine) Tablet 20 mg/120 mg Riamet Malaysia - Novartis Corporation (Malaysia) Sdn. Bhd -
7 Artesunate - - Arsumax Arsuamoon - - Sanofi F Guilin Pharmaceuticals (China) -
8 Atenolol Tablet 100 mg Tenormin Malaysia Astrazeneca UK Limited Astrazeneca -
9 Carvedilol Tablet 25 mg Dilatrend Malaysia Delpharm Milano S.R.L, Italy DKSH Malaysia SDN BHD -
10 Cefdinir Kapsul 300 mg Cefdinir USA - Sandoz Inc -

LIST OF GENERIC DRUGS THAT HAVE MEET THE BIOECIVALENCE CRITERIA IN 2022

No ZAT AKTIF BENTUK SEDIAAN KEKUATAN NAMA DAGANG NIE PRODUSEN PENDAFTAR STATUS
121 Cefixime Trihydrate Kapsul 100 mg Nucef DKL0808014601A1 Tanggal Terbit 05-10-2018 DARYA VARIA LABORATORIA - INDONESIA GUARDIAN PHARMATAMA - INDONESIA Obat Generik
122 Cefixime Trihydrate Kapsul 100 mg Lafsefik 100 DKL2043800301A1 Tanggal Terbit 14-08-2020 LEMBAGA FARMASI ANGKATAN UDARA ROOSTYAN EFFENDIE - INDONESIA LEMBAGA FARMASI ANGKATAN UDARA ROOSTYAN EFFENDIE - INDONESIA Obat Generik
123 Cefixime Trihydrate Kapsul 200 mg Starcef DKL0605040501A1 Tanggal Terbit 26-07-2020 DEXA MEDICA - INDONESIA DEXA MEDICA - INDONESIA Obat Generik
124 Cefixime Trihydrate Kapsul 200 mg Cefixime GKL0933521201B1 Tanggal Terbit 29-12-2017 ETERCON PHARMA - INDONESIA NOVELL PHARMACEUTICAL LAB - INDONESIA Obat Generik
125 Cefixime Trihydrate Kapsul 200 mg Cefila DKL0813314001A1 Tanggal Terbit 29-03-2018 LAPI - INDONESIA LAPI - INDONESIA Obat Generik
126 Cefixime Trihydrate Kapsul 200 mg Nixaven 200 DKL1033522101B1 Tanggal Terbit 17-11-2020 ETERCON PHARMA - INDONESIA NOVELL PHARMACEUTICAL LAB - INDONESIA Obat Generik
127 Cefixime Trihydrate Kapsul 200 mg Profim DKL2133217201A1 Tanggal Terbit 18-03-2022 PROMEDRAHARDJO FARMASI INDUSTRI - Indonesia PROMEDRAHARDJO FARMASI INDUSTRI - INDONESIA Obat Generik
128 Cefixime Trihydrate Kaplet Salut Selaput 200 mg Fixacep 200 DKL9731515917A1 Tanggal Terbit 14-10-2022 PRATAPA NIRMALA - INDONESIA PRATAPA NIRMALA - INDONESIA Obat Generik
129 Cefixime Trihydrate Kaplet Salut Selaput 200 mg Sporetik DKL1622254309A1 Tanggal Terbit 20-09-2017 SANBE FARMA - INDONESIA SANBE FARMA - INDONESIA Obat Generik
130 Cefixime Trihydrate Kaplet Salut Selaput 200 mg Anfix DKL0913705109A1 Tanggal Terbit 22-04-2021 DARYA VARIA LABORATORIA TBK PLANT CITEUREUP - INDONESIA MAHAKAM BETA FARMA - INDONESIA Obat Generik

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