JADWAL PELAYANAN REGISTRASI VARIASI & RENEWAL OBAT GENERIK Kepada Industri Farmasi : "Agar produk yang di-input ke dalam website antrian email adalah produk yang sudah siap kelengkapannya sesuai dengan checklist registrasi yang diajukan, untuk menghindari terjadinya penggantian produk saat waktu pelayanan dan ketidaksiapan dokumen yang sudah dijadwalkan. Terima kasih." REGISTRASI VARIASI OG (BERKAS BARU) No. Tanggal Pelayanan Pendaftar Produk 1 Senin, 10 September 2018 PT. Dexa Medica Glimepiride 1 Tab 2 Senin, 10 September 2019 PT. Dexa Medica Gluvas 1 Tab 3 Senin, 10 September 2020 PT. Ferron Par Pharmaceuticals Diaversa 1 Tab 4 Senin, 10 September 2021 PT. Tropica Mas Pharmaceuticals New Antides 5 Senin, 10 September 2022 PT. Tropica Mas Pharmaceuticals Tropigesic 6 Senin, 10 September 2023 PT. Soho Industri Pharmasi Mobiflex 15 7 Senin, 10 September 2024 PT. Tempo Scan Pacific Amlodipine 5 8 Senin, 10 September 2025 PT. Tempo Scan Pacific Simvastatin 9 Senin, 10 September 2026 10 Senin, 10 September 2027 PT. Otto Pharmaceutical Industries Methylprednisolone 4 PT. Pertiwi Agung Lanamol No. Tanggal Pelayanan Pendaftar Produk 1 Selasa, 11 September 2018 LIBUR LIBUR 2 Selasa, 11 September 2019 LIBUR LIBUR 3 Selasa, 11 September 2020 LIBUR LIBUR 4 Selasa, 11 September 2021 LIBUR LIBUR 5 Selasa, 11 September 2022 LIBUR LIBUR 6 Selasa, 11 September 2023 LIBUR LIBUR 7 Selasa, 11 September 2024 LIBUR LIBUR 8 Selasa, 11 September 2025 LIBUR LIBUR 9 Selasa, 11 September 2026 LIBUR LIBUR 10 Selasa, 11 September 2027 LIBUR LIBUR
REGISTRASI VARIASI OG (RESUBMIT) No. Tanggal Pelayanan Pendaftar Produk 1 Senin, 10 September 2018 PT. PIM Pharmaceuticals Analpim 2 Senin, 10 September 2019 PT. Pharos Indonesia Intrix 3 Senin, 10 September 2020 PT. Erlimpex Neomethor 4 Senin, 10 September 2021 5 Senin, 10 September 2022 6 Senin, 10 September 2023 7 Senin, 10 September 2024 8 Senin, 10 September 2025 9 Senin, 10 September 2026 10 Senin, 10 September 2027 No. Tanggal Pelayanan Pendaftar Produk 1 Selasa, 11 September 2018 LIBUR LIBUR 2 Selasa, 11 September 2019 LIBUR LIBUR 3 Selasa, 11 September 2020 LIBUR LIBUR 4 Selasa, 11 September 2021 LIBUR LIBUR 5 Selasa, 11 September 2022 LIBUR LIBUR 6 Selasa, 11 September 2023 LIBUR LIBUR 7 Selasa, 11 September 2024 LIBUR LIBUR 8 Selasa, 11 September 2025 LIBUR LIBUR 9 Selasa, 11 September 2026 LIBUR LIBUR 10 Selasa, 11 September 2027 LIBUR LIBUR
RENEWAL OG No. Tanggal Pelayanan Pendaftar Produk Tanggal Berakhir NIE 1 Senin, 10 September 2018 PT. Dexa Medica MERTIGO 13-Apr-19 2 Senin, 10 September 2019 PT. Dexa Medica Betahistine Mesilate 27-Jun-19 3 Senin, 10 September 2020 PT. Phapros, Tbk Diapros 17-Okt-19 4 Senin, 10 September 2021 PT. Phapros, Tbk Zinc Sulphate 17-Okt-19 5 Senin, 10 September 2022 PT. Indofarma Isosorbid dinitrate 25-Sep-19 6 Senin, 10 September 2023 PT. Harsen Metrolet 03-Sep-19 7 Senin, 10 September 2024 PT. Ikapharmindo Putramas Agrelano 31-Mar-19 8 Senin, 10 September 2025 PT. Guardian Pharmatama Donepezil HCl 21-Mar-19 9 Senin, 10 September 2026 PT. Guardian Pharmatama Ponsamic 500 13-Apr-19 10 Senin, 10 September 2027 PT. Kalbe Farma Pospargin 27-Jun-19 No. Tanggal Pelayanan Pendaftar Produk Tanggal Berakhir NIE 1 Selasa, 11 September 2018 LIBUR LIBUR LIBUR 2 Selasa, 11 September 2019 LIBUR LIBUR LIBUR 3 Selasa, 11 September 2020 LIBUR LIBUR LIBUR 4 Selasa, 11 September 2021 LIBUR LIBUR LIBUR 5 Selasa, 11 September 2022 LIBUR LIBUR LIBUR 6 Selasa, 11 September 2023 LIBUR LIBUR LIBUR 7 Selasa, 11 September 2024 LIBUR LIBUR LIBUR 8 Selasa, 11 September 2025 LIBUR LIBUR LIBUR 9 Selasa, 11 September 2026 LIBUR LIBUR LIBUR 10 Selasa, 11 September 2027 LIBUR LIBUR LIBUR No. Tanggal Pelayanan Pendaftar Produk Tanggal Berakhir NIE 1 Rabu, 5 September 2018 PT. Corsa Industries Corstanal 02-Mei-19 2 Rabu, 5 September 2018 PT. Kimia Farma Loprezol Kapsul Lepas Lambat 03-Mar-19 3 Rabu, 5 September 2018 PT. Erlimpex Emeran Tab 30-Jul-19 4 Rabu, 5 September 2018 PT. Holi Pharma Gitri Kaplet 28-Nop-18 5 Rabu, 5 September 2018 PT. Promedrahardjo Cotrimoxazole Tab 13-Mei-19 6 Rabu, 5 September 2018 PT. Novell Pharmaceutical Diclofenac Na TSE 24-Okt-18 7 Rabu, 5 September 2018 PT. Graha Farma Grantusif Kaplet 12-Nop-18 8 Rabu, 5 September 2018 PT. Hexpharm Jaya Girabloc Tab SS 02-Jun-19 9 Rabu, 5 September 2018 PT. Hexpharm Jaya Ciprofloxacin HCI Tab SS 03-Apr-19 10 Rabu, 5 September 2018 PT. Sterling Products Indonesia Panadol Syrup 60 ml 26-Mei-2019
No. Tanggal Pelayanan Pendaftar Produk Tanggal Berakhir NIE 1 Kamis, 6 September 2018 PT. Phapros Nacoflar 25 23-12-2018 2 Kamis, 6 September 2018 PT. Oryza Farma Shinoxol 30 Tab 23-Des-18 3 Kamis, 6 September 2018 PT. Lapi Lacophen 500 Kapsul 09-Jul-19 4 Kamis, 6 September 2018 PT. Lapi Lacophen DS 22-Jul-19 5 Kamis, 6 September 2018 PT. Genero Pharmaceuticals Tracor Kapsul 03-Mar-19 6 Kamis, 6 September 2018 PT. Interbat Lotyn Tab 27-Nop-18 7 Kamis, 6 September 2018 PT. Dankos Farma Zeos Sirup 18-Nop-18 8 Kamis, 6 September 2018 PT. Harsen Tensidox 1 Tab 27-Jun-19 9 Kamis, 6 September 2018 PT Yarindo Farmatama Pantorin Serb inj 21-Jan-19 10 Kamis, 6 September 2018 PT Yarindo Farmatama Rindopump Serb inj 27-Feb-19
CADANGAN REGISTRASI VARIASI OG No. PENDAFTAR NAMA OBAT 1 PT. Dexa Medica GLIMEPIRIDE 2 Tab 2 PT. Dexa Medica Gluvas 2 Tab 3 PT. Ferron Par Diaversa 2 Pharmaceuticals 4 PT. Tropica Mas TROPIMAG Pharmaceuticals 5 PT. Tempo Scan Pacific Tbk DOMPERIDONE MALEATE 6 Tempo Scan Pacific AMLODIPINE 10 MG 7 TEMPO SCAN PACIFIC AMLODIPINE 10 MG (TAMBAH LOKASI PROSES TABLETTING) 8 PT Lapi ALEGI 9 PT. Kalbe Farma, Tbk Mycoral 10 PT. Sterling Products Triaminic Pilek Batuk + Pilek (Rasa 11 Indonesia, PT. Sterling Jakarta Products Berry) Triaminic Sirup Pilek (Rasa Jeruk) Sirup Indonesia, Jakarta 12 PT. Sterling Products Triaminic Ekspektoran + Pilek (Rasa 13 Indonesia, PT. PHAROS Jakarta INDONESIA Lemon) NERIPROS Sirup2 Tab ss 14 PT. Kalbe Farma, Tbk Angioten Tab ss 15 PT. Novell Pharmaceutical NOPRENIA Larutan 16 Darya-Varia Laboratoria NORIZEC 1 (Khusus Ekspor) Tab 17 PT. Hexpharm Jaya Ranitidine HCl Injeksi 18 PT. PRATAPA NIRMALA - TANGERANG FARGOXIN Injeksi 19 PT. MAHAKAM BETA FARMA CEFAZOLIN SODIUM Serbuk Injeksi 20 PT. NULAB RAFACORT Tablet 21 INDONESIA PT. NULAB TRIAMCINOLONE Tablet 22 PT. PHAROS INDONESIA KOLTON 100 Tablet 23 PT ROHTO NEO LEVO Tetes Mata 24 INDONESIA PT. DION FARMA ABADI CALMDION Krim 25 PT. DION FARMA ABADIPT. CALMDION Krim 26 DION FARMA ABADI, KLATEN PT. MEPROFARM SUPRAMOX Drops 27 PT MEPROFARM LOGAFOX Serbuk Injeksi 28 PT. HEXPHARM JAYA LAMBUCID Tablet Kunyah 29 PT.FUTAMED S CETIRIZINE HYDROCHLORIDE Tablet 30 PT. FUTAMED RYBEST Tablet 31 S PT. ETHICA AMINORAL Kaplet 32 PT. Erlimpex Bromhexin HCL 33 PT. Kalbe Farma, Tbk Divoltar 34 PT. Nulab Pharmaceutical Lansoprazole Indonesia 35 PT. KIMIA FARMA, MEDAN PARACETAMOL 36 PT. SAMPHARINDO CARDIPIN 5 PERDANA 37 PT. Promedrahardjo FI Profat 38 PT. Dexa Medica GLIMEPIRIDE Tab 1 mg 39 PT. Dexa Medica GLIMEPIRIDE Tab 2 mg 40 PT. Dexa Medica GLIMEPIRIDE Tab 3 mg 41 PT. Dexa Medica GLIMEPIRIDE Tab 4 mg 42 PT. Erlimpex Erphahexin 43 PT. PRATAPA NIRMALA RENAQUIL 44 PT. Guardian Pharmatama NYNDIA 45 PT. MOLEX AYUS METHYL PREDNISOLONE 46 PT. Kimia Farma Mojokerto Miconazole nitrate 47 PT Ikapharmindo Putramas OBH DRYL 48 PT. Indofarma, Tbk. Clindamycin HCl 49 PT. Indofarma, Tbk. Ceftriaxone Sodium
50 PT. Indofarma, Tbk. Ketorolac Tromethamol 51 PT. Indofarma, Tbk. Ketoflam 52 PT. Nulab Pharmaceutical Indonesia RAFACORT 53 PT. Nulab Pharmaceutical Indonesia TRIAMCINOLONE 54 PT. Dankos Farma, Jakarta CEREMAX 55 PT. IFARS LERZIN 56 PT Darya-Varia Laboratoria Tbk PARATUSIN 57 PT. Mulia Farma Suci Pacdin Cough Strawberry 58 PT. DEXA MEDICA ISORANE 59 PT. Genero Pharmaceuticals ERAZOL 60 PT. Indofarma, tbk Clindamycin 61 PT. Indofarma, tbk ceftriaxone 62 PT. Pharos Indonesia cefophar 63 PT. Genero Pharmaceuticals Esinol 64 PT Yarindo Farmatama Ibuprofen 400 65 PT Kalbe Farma Kalpanax K 66 PT. Graha Farma GRAFADON FORTE 67 PT. Graha Farma ALFIDON 68 PT. Graha Farma ATMACID 69 PT. Graha Farma TYREMA 70 PT. Graha Farma FLUCADEX 71 PT. Graha Farma GRAXINE 72 PT. Graha Farma BRONKRIS 73 PT. Graha Farma GRAFADON 74 PT. Graha Farma HISTAKLOR 75 PT. Graha Farma FLUNAX 76 PT Tempo Scan Pacific, tbk Simvastatin 20
CADANGAN REGISTRASI ULANG No. Pendaftar Produk Tanggal Berakhir NIE 1 PT Lucas Djaja Obagi Nu Derm (data yang dikirim tidak lengkap, 2 PT Widatra Bhakti WIDA RL (data tidak yang ada informasi dikirim tidak tgl berakhir lengkap, 3 PT Dexa Medica Fludexin Syrup tidak ada informasi 28-Apr-19tgl berakhir 4 PT.DEXA MEDICA DEXYCLAV 27 MEI 2019 5 PT DEXA MEDICA PRONALGES 18-05-2019 6 PT. Phapros, Tbk Phaminov 06-10-2019 7 PT DEXA MEDICA PIRACETAM KSS 400 30-04-2019 8 PT DEXA MEDICA PIRACETAM KSS 800 30-04-2019 9 PT DEXA MEDICA PIRACETAM Kapsul 30-04-2019 10 PT Dexa Medica AGGRAVAN 23-06-2019 11 PT. Dexa Medica Mecox 7.5 23-06-2019 12 PT Dexa Medica Mecox 15 23-06-2019 13 PT. Guardian Pharmatama EXTROPECT 11 maret 2019 14 PT. Lapi LACOLDIN Tab 22/07/2019 15 PT. Kimia Farma, Tbk., Jakarta Doxycycline Hyclate Kapsul 03-04-2019 16 PT. Kimia Farma, Tbk., Jakarta Kombipak Azithromycin Cefixime 27-06-2019 17 PT. Kimia Farma, Bandung Kaplet CAPTOPRIL ss Tab (10x10) 25 April 2019 18 PT. Kimia Farma, Bandung CAPTOPRIL Tab (6x10) 25 April 2019 19 PT. Kimia Farma, Bandung Retaphyl SR Kaptab lps lmbt 20 September 2019 20 PT. Phapros Corsona Tab 27-Jul-19 21 PT. Dankos Farma, Jakarta BRAINACT 250 Inj 20-02-2019 22 PT. Dankos Farma, Jakarta BRAINACT 500 Inj 21-08-2019 23 PT. Dankos Farma, Jakarta BRAINACT 1000 Inj 20-02-2019 24 PT.Indofarma allopurinol 100 Tab 27-02-2019 25 PT. Hexpharm Jaya Omeprazole Kapsul 03 Feb 2019 26 PT. Hexpharm Jaya Tamezol 20 Kapsul 03 Feb 2019 27 PT. Hexpharm Jaya Ondansetron HCl 4 mg Inj 27 Jun 2019 28 PT. Hexpharm Jaya Ondansetron HCl 8 mg Inj 27 Jun 2019 29 PT. Promedrahardjo FI ANTASIDA Tab kunyah 07/05/2019 30 PT. PRATAPA NIRMALA INOVAD Inj 28-08-2019 31 PT. BALATIF BETALGIN Kaptab 23-09-2018 32 PT PYRIDAM FARMA TBK PREDNOX Injeksi 04 Nopember 2018 33 PT. ERLIMPEX ERPHADROX Sirup Kering 27-06-2019 34 PT. SUNTHI SEPURI SIMECO Tablet Kunyah 19 November 2018 35 PT. METISKA FARMA METXIME Serbuk Injeksi 5 Desember 2018 36 PT. PHAROS INDONESIA AZTRIN Sirup Kering 28-11-2018 37 PT IMMORTAL ACELAXON Krim 05-08-2019 38 PT IMMORTAL IMFURO Krim 05-08-2019 39 PT. FERRON PAR HISTRINE Tablet Salut Selaput 09-06-2019 S 40 PT IKAPHARMINDO AQUA PRO INJECTION Cairan 22-09-2019 PUTRAMAS Injeksi 41 PT DARYA-VARIA KENDARON Tablet 10-08-2019 LABORATORIA TBK 42 PT HARSEN DECATRIM Tablet 13-07-2019 43 PT IFARS FARIDEXON FORTE Kaplet 23/03/2019 44 PT IFARS SELVIM 10 Kaplet 11/05/2019 45 PT. GUARDIAN STROMAG Tablet 31 Oktober 2018 PHARMATAMA - BOGOR 46 PT.ERELA THIPUTIC 500 Kapsul 27-06-2019 47 PT. DEXA MEDICA FLADYSTIN Ovula 28-04-2019 48 PT. CORONET CROWN ANTIZA Kaptab S.S 27 Juli 2019 49 PT. SOLAS LANGGENG FIXAM Suspensi Kering 31-10-2018 SEJAHTERA 50 PT. SOLAS LANGGENG FIXAM Kapsul 31-10-2018 SEJAHTERA 51 PT YARINDO FARMATAMA MUCYLIN Kapsul 06-03-2019
52 PT. DEXA MEDICA NICARDIPINE HCL Injeksi 27 Juni 2019 53 PT. PABRIK PHARMASI ZEPHANAL Kapsul 26-06-2019 ZENITH 54 PT. CENDO CENFRESH MD Tetes Mata 23-11-2018 55 PT. CENDO CENFRESH 5 ML Tetes Mata 23-11-2018 56 PT. CENDO CENFRESH 15 ML Tetes Mata 23-11-2018 57 PT COMBIPHAR NEO-K Injeksi 17 Maret 2019 58 PT INFION SULPEFION Serbuk Injeksi 12-08-2019 59 PT. PERTIWI AGUNG METHISOPRINOL Tablet 26 Juni 2019 60 PT PYRIDAM FARMA TBK PREDNOX 8 Kaplet 14 Spetember 2019 61 PT. IKAPHARMINDO GENTASOLON Krim 4 Agustus 2019 PUTRAMAS 62 PT. IKAPHARMINDO SALDONA Tablet 5 Agustus 2019 PUTRAMAS 63 PT DIPA PHARMALAB GEMEDAC Serbuk Infus 200 07-05-2019 INTERSAINS 64 PT DIPA PHARMALAB GEMEDAC Serbuk Infus 1000 07-05-2019 65 PT. DANKOS FARMA, MEXPHARM Tablet 04-08-2019 JAKARTA 66 PT NATURA LABORATORIA QUABACEF Serbuk Injeksi 4-10-2018 PRIMA 67 PT NATURA LABORATORIA CEFOPERAZONE SODIUM - 16-10-2018 PRIMA SULBACTAM SODIUM Serbuk Injeksi 68 PT. Guardian Pharmatama RIZODAL 1 21 Januari 2019 69 PT. Immortal Pharmaceutical Imfuro 05-08/2019 70 PT. Kalbe Farma, Tbk Aminofusin L-600 11 May 2019 71 PT.Erela trisela 22-09-2019 72 PT.Erela cetirizine HCL 13-03-2019 73 PT. Dankos Farma, Jakarta MEXPHARM 15 04-08-2019 74 MEPROFARM SIZORIL-25 19 JULI 2019 75 PT. HENSON FARMA ULTRAFLU EXTRA 30-03-2019 76 PT. Pabrik Pharmasi Zenith Dombaz 23-12-2018 77 PT PERTIWI AGUNG VALANSIM 10 23 DESEMBER 2018 78 PT PERTIWI AGUNG SIMVASTATIN 31 MARET 2019 79 PT Aventis Pharma Recansa 10 10-01-2019 80 Dexa Medica Ceftazidime Pentahydrate 21 Februari 2019 81 PT. PRATAPA NIRMALA - Farlev 750 3 April 2019 TANGERANG 82 PT. Berlico Mulia Farma DEHISTA 30-04-2019 83 PT HARSEN Fusaltrax 27 Juni 2019 84 Dexa Medica Cefazolin Sodium 27 Mei 2019 85 PT. Phapros, Tbk Nacoflar 50 27-06-2019 86 PT. Phapros, Tbk Phaproxin 17-08-2019 87 PT Aventis Pharma Recansa 20 10-01-2019 88 PT. MERSIFARMA TM HALOPERIDOL 5 3 Januari 2019 89 SIMEX SIMVASK-10 13-04-2019 90 SIMEX SIMVASK-5 13-04-2019 91 PT. Tempo Scan Pacific GITAFAT 4 September 2019 92 PT Indofarma Tbk Asam Mefenamat 2 September 2019 93 PT Indofarma Tbk Piroxicam 10 November 2019 94 PT. CORSA INDUSTRIES COCEFIN 27-06-2019 95 PT. Kalbe Farma, Tbk Mycoral 15 April 2019 96 PT Immortal Pharmaceutical NIOTINEX 21-08-2019 97 PT Immortal Pharmaceutical NIOTINEX FORTE 21-08-2019 98 PT. MERSIFARMA TM FLOTAVID 200 28-02-2019 99 PT SANBE FARMA SANCORTMYCIN (resubmit) 22-04-2018 100 PT. Dankos Farma, Jakarta ZEFTRIX 21-08-2019 101 PT. IFARS 24-10-2018 IFARSYL PLUS 102 PT. CORONET CROWN TILARCO 27 Juni 2019 103 PT. CORONET CROWN ANTIZA 27 Januari 2019 104 PT NOVELL 6 FEBRUARI 2019 ONDANSETRON TSS 8 MG 105 PT NOVELL AZITHROMYCIN 18 FEBRUARI 2019
106 PT. Guardian Pharmatama NUZIP 25 31 Oktober 2018 107 PT. Guardian Pharmatama NUZIP 100 31 Oktober 2018 108 PT. Sunthi Sepuri FEBRYN 4 Agustus 2019 109 PT. Sunthi Sepuri GUNACETA 14 Agustus 2019 110 PT. SAMPHARINDO SALBUTAMOL SULFATE PERDANA (resubmit) 30 MEI 2019 111 PT. SAMPHARINDO PERDANA MIRAPECT (RESUBMIT) 27 JULI 2019 112 PT IFARS Pharmaceutical Ifarsyl Plus 24/10/2018 113 PT. MERSIFARMA TM FLOTAVID 200 28-02-2019 114 PT. Mutiara Mukti Farma (MUTIFA) Omevomid 31-01-2019 115 PT Actavis Indonesia ALEROS 10-12-2018 116 PT Actavis Indonesia LORINID MITE 16-12-2018 117 PT. CORSA INDUSTRIES CLACOR 22-07-2019 118 PT Yarindo Farmatama RINDOBION 5000 03-05-2019 119 PT. Darya-Varia Laboratoria VIGOR-ACE 14 Maret 2019 120 PT Darya-Varia Laboratoria Tbk Daryaven 27 Juni 2019 121 PT Darya-Varia Laboratoria Tbk Doripenem 27 Juni 2019 122 PT. Pabrik Pharmasi Zenith Antalgin 10-08-2019 123 PT. SOLAS LANGGENG SEJAHTERA Soldextam (TD) 18-02-2019 124 PT. Finusolprima Farma internasional VOMINA 11-07-2019 125 PT TEMPO SCAN PACIFIC SCANNAFLAM 50 05-08-2019 126 Dexa Medica DEXAFLOX 23-06-2019 127 PT. PRATAPA NIRMALA - TANGERANG FIXACEP OD 28-11-2018