China drug re-registration deadlines falling in 2031
106 overseas-manufactured drug certificates whose Art. 82 re-registration deadline falls in 2031. NMPA public data, snapshot 2026-09-10.
| Approval number | Product | Holder | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|---|
| 国药准字ZJ20160009 | Extract of St. John`s Wort Tablets 圣·约翰草提取物片 | Dr. Willmar Schwabe GmbH & Co. KG | 2031-07-01 | 2031-01-01 |
| 国药准字HJ20260067 | Tadalafil Tablets 他达拉非片 | Sawai Pharmaceutical Co., Ltd. | 2031-07-07 | 2031-01-07 |
| 国药准字SJ20210025 | DARZALEX FASPRO 达雷妥尤单抗注射液（皮下注射） | Janssen-Cilag International NV | 2031-07-09 | 2031-01-09 |
| 国药准字HJ20160642 | Invega Sustenna 棕榈酸帕利哌酮注射液 | Janssen-Cilag International NV | 2031-07-12 | 2031-01-12 |
| 国药准字HJ20160643 | Invega Sustenna 棕榈酸帕利哌酮注射液 | Janssen-Cilag International NV | 2031-07-12 | 2031-01-12 |
| 国药准字HJ20160644 | Invega Sustenna 棕榈酸帕利哌酮注射液 | Janssen-Cilag International NV | 2031-07-12 | 2031-01-12 |
| 国药准字HJ20170001 | Paroxetine Hydrochloride Enteric-Coated Sustained-Release Tablets 盐酸帕罗西汀肠溶缓释片 | GLAXOSMITHKLINE INC. | 2031-07-12 | 2031-01-12 |
| 国药准字HJ20170002 | Paroxetine Hydrochloride Enteric-Coated Sustained-Release Tablets 盐酸帕罗西汀肠溶缓释片 | GLAXOSMITHKLINE INC. | 2031-07-12 | 2031-01-12 |
| 国药准字HJ20210068 | Sildenafil Citrate Tablets 枸橼酸西地那非片 | Aurobindo Pharma Limited | 2031-07-12 | 2031-01-12 |
| 国药准字HJ20210069 | Sildenafil Citrate Tablets 枸橼酸西地那非片 | Aurobindo Pharma Limited | 2031-07-12 | 2031-01-12 |
| 国药准字HJ20170117 | FORXIGA 达格列净片 | AstraZeneca AB | 2031-07-13 | 2031-01-13 |
| 国药准字HJ20170118 | FORXIGA 达格列净片 | AstraZeneca AB | 2031-07-13 | 2031-01-13 |
| 国药准字HJ20170119 | FORXIGA 达格列净片 | AstraZeneca AB | 2031-07-13 | 2031-01-13 |
| 国药准字HJ20170120 | FORXIGA 达格列净片 | AstraZeneca AB | 2031-07-13 | 2031-01-13 |
| 国药准字HJ20170205 | FORXIGA 达格列净片 | AstraZeneca AB | 2031-07-13 | 2031-01-13 |
| 国药准字HJ20170206 | FORXIGA 达格列净片 | AstraZeneca AB | 2031-07-13 | 2031-01-13 |
| 国药准字HJ20171069 | Transmetil 注射用丁二磺酸腺苷蛋氨酸 | ABBOTT LABORATORIES DE MEXICO, S.A. DE C.V. | 2031-07-19 | 2031-01-19 |
| 国药准字HJ20171084 | Transmetil 注射用丁二磺酸腺苷蛋氨酸 | ABBOTT LABORATORIES DE MEXICO, S.A. DE C.V. | 2031-07-19 | 2031-01-19 |
| 国药准字HJ20171166 | Trajenta 利格列汀片 | Boehringer Ingelheim International GmbH | 2031-07-19 | 2031-01-19 |
| 国药准字HJ20171167 | Trajenta 利格列汀片 | Boehringer Ingelheim International GmbH | 2031-07-19 | 2031-01-19 |
| 国药准字HJ20171168 | Trajenta 利格列汀片 | Boehringer Ingelheim International GmbH | 2031-07-19 | 2031-01-19 |
| 国药准字HJ20171169 | Trajenta 利格列汀片 | Boehringer Ingelheim International GmbH | 2031-07-19 | 2031-01-19 |
| 国药准字HJ20171366 | Sirturo 富马酸贝达喹啉片 | Janssen-Cilag International NV | 2031-07-19 | 2031-01-19 |
| 国药准字HJ20260068 | ORZEYFUL 奥普雷顿片 | Takeda Pharmaceuticals U.S.A., Inc. | 2031-07-20 | 2031-01-20 |
| 国药准字HJ20260069 | ORZEYFUL 奥普雷顿片 | Takeda Pharmaceuticals U.S.A., Inc. | 2031-07-20 | 2031-01-20 |
| 国药准字HJ20260070 | ORZEYFUL 奥普雷顿片 | Takeda Pharmaceuticals U.S.A., Inc. | 2031-07-20 | 2031-01-20 |
| 国药准字HJ20160584 | Sumamed 阿奇霉素干混悬剂 | Pliva Croatia Ltd. | 2031-07-21 | 2031-01-21 |
| 国药准字HJ20160585 | Sumamed 阿奇霉素干混悬剂 | Pliva Croatia Ltd. | 2031-07-21 | 2031-01-21 |
| 国药准字SJ20160039 | Gonal-F 重组人促卵泡激素注射液 | Merck Europe B.V. | 2031-07-23 | 2031-01-23 |
| 国药准字SJ20160040 | Gonal-F 重组人促卵泡激素注射液 | Merck Europe B.V. | 2031-07-23 | 2031-01-23 |
| 国药准字SJ20160041 | Gonal-F 重组人促卵泡激素注射液 | Merck Europe B.V. | 2031-07-23 | 2031-01-23 |
| 国药准字SJ20160048 | Humulin NPH 精蛋白人胰岛素注射液 | Lilly France | 2031-07-23 | 2031-01-23 |
| 国药准字SJ20160049 | Humulin NPH 精蛋白人胰岛素注射液 | Lilly France | 2031-07-23 | 2031-01-23 |
| 国药准字SJ20160050 | Humulin NPH 精蛋白人胰岛素注射液 | Lilly France | 2031-07-23 | 2031-01-23 |
| 国药准字SJ20235002 | Gonal-F 重组人促卵泡激素注射液 | Merck Europe B.V. | 2031-07-23 | 2031-01-23 |
| 国药准字HJ20160539 | Sigmart 尼可地尔片 | Chugai Pharmaceutical Co.,Ltd. | 2031-07-27 | 2031-01-27 |
| 国药准字HJ20160540 | Sigmart 尼可地尔片 | Chugai Pharmaceutical Co.,Ltd. | 2031-07-27 | 2031-01-27 |
| 国药准字HJ20210072 | Cefcapene Pivoxil Hydrochloride Granules 盐酸头孢卡品酯颗粒 | Shionogi & Co., Ltd. | 2031-07-27 | 2031-01-27 |
| 国药准字HJ20260071 | Flurbiprofen Patches 氟比洛芬贴剂 | MIKASA SEIYAKU CO., LTD | 2031-08-03 | 2031-02-03 |
| 国药准字HJ20160502 | Prepenem 注射用亚胺培南西司他丁钠 | JW PHARMACEUTICAL CORPORATION | 2031-08-06 | 2031-02-06 |
| 国药准字HJ20160636 | ZIAGEN 硫酸阿巴卡韦片 | ViiV Healthcare B.V. | 2031-08-06 | 2031-02-06 |
| 国药准字HJ20170133 | Jakavi 磷酸芦可替尼片 | Novartis Europharm Limited | 2031-08-06 | 2031-02-06 |
| 国药准字HJ20170134 | Jakavi 磷酸芦可替尼片 | Novartis Europharm Limited | 2031-08-06 | 2031-02-06 |
| 国药准字HJ20171067 | Hyzaar 氯沙坦钾氢氯噻嗪片 | N.V. Organon | 2031-08-06 | 2031-02-06 |
| 国药准字HJ20171073 | Hyzaar 氯沙坦钾氢氯噻嗪片 | N.V. Organon | 2031-08-06 | 2031-02-06 |
| 国药准字HJ20171090 | Temozolomide Capsules 替莫唑胺胶囊 | Merck Sharp & Dohme B.V. | 2031-08-06 | 2031-02-06 |
| 国药准字HJ20171091 | Temozolomide Capsules 替莫唑胺胶囊 | Merck Sharp & Dohme B.V. | 2031-08-06 | 2031-02-06 |
| 国药准字HJ20171320 | Temozolomide Capsules 替莫唑胺胶囊 | Merck Sharp & Dohme B.V. | 2031-08-06 | 2031-02-06 |
| 国药准字HJ20171321 | Temozolomide Capsules 替莫唑胺胶囊 | Merck Sharp & Dohme B.V. | 2031-08-06 | 2031-02-06 |
| 国药准字HJ20160371 | Sinemet 卡左双多巴缓释片 | ORGANON Healthcare GmbH | 2031-08-10 | 2031-02-10 |
| 国药准字HJ20160372 | Sinemet 卡左双多巴缓释片 | ORGANON Healthcare GmbH | 2031-08-10 | 2031-02-10 |
| 国药准字HJ20171182 | APROVEL 厄贝沙坦片 | Sanofi Winthrop Industrie | 2031-08-17 | 2031-02-17 |
| 国药准字HJ20171183 | APROVEL 厄贝沙坦片 | Sanofi Winthrop Industrie | 2031-08-17 | 2031-02-17 |
| 国药准字HJ20171184 | APROVEL 厄贝沙坦片 | Sanofi Winthrop Industrie | 2031-08-17 | 2031-02-17 |
| 国药准字HJ20171185 | APROVEL 厄贝沙坦片 | Sanofi Winthrop Industrie | 2031-08-17 | 2031-02-17 |
| 国药准字HJ20171186 | APROVEL 厄贝沙坦片 | Sanofi Winthrop Industrie | 2031-08-17 | 2031-02-17 |
| 国药准字HJ20171187 | APROVEL 厄贝沙坦片 | Sanofi Winthrop Industrie | 2031-08-17 | 2031-02-17 |
| 国药准字HJ20220047 | Letermovir Injection 来特莫韦注射液 | Merck Sharp & Dohme B.V. | 2031-08-17 | 2031-02-17 |
| 国药准字HJ20220048 | Letermovir Injection 来特莫韦注射液 | Merck Sharp & Dohme B.V. | 2031-08-17 | 2031-02-17 |
| 国药准字HJ20260072 | Oxcarbazepine Oral Suspension 奥卡西平口服混悬液 | Hetero Labs Limited | 2031-08-17 | 2031-02-17 |
| 国药准字HJ20170199 | Solu-Medrol 注射用甲泼尼龙琥珀酸钠 | Pfizer NV/SA | 2031-08-20 | 2031-02-20 |
| 国药准字HJ20170362 | Entresto 沙库巴曲缬沙坦钠片 | Novartis Pharma Schweiz AG | 2031-08-20 | 2031-02-20 |
| 国药准字HJ20170363 | Entresto 沙库巴曲缬沙坦钠片 | Novartis Pharma Schweiz AG | 2031-08-20 | 2031-02-20 |
| 国药准字HJ20170364 | Entresto 沙库巴曲缬沙坦钠片 | Novartis Pharma Schweiz AG | 2031-08-20 | 2031-02-20 |
| 国药准字HJ20171298 | BETMIGA 米拉贝隆缓释片 | Astellas Pharma Europe B.V. | 2031-08-20 | 2031-02-20 |
| 国药准字HJ20171299 | BETMIGA 米拉贝隆缓释片 | Astellas Pharma Europe B.V. | 2031-08-20 | 2031-02-20 |
| 国药准字HJ20210079 | CRESEMBA 硫酸艾沙康唑胶囊 | Pfizer Australia Pty Ltd | 2031-08-20 | 2031-02-20 |
| 国药准字HJ20210085 | Prevymis 来特莫韦片 | Merck Sharp & Dohme B.V. | 2031-08-20 | 2031-02-20 |
| 国药准字HJ20210086 | Prevymis 来特莫韦片 | Merck Sharp & Dohme B.V. | 2031-08-20 | 2031-02-20 |
| 国药准字HJ20220026 | Tetrofosmin and Stannous Chloride for Injection 注射用亚锡替曲膦 | GE HEALTHCARE AS | 2031-08-20 | 2031-02-20 |
| 国药准字HJ20260073 | Lomustine Capsules 洛莫司汀胶囊 | Azurity Pharmaceuticals, Inc. | 2031-08-24 | 2031-02-24 |
| 国药准字HJ20260074 | Icotrokinra Hydrochloride Tablets 盐酸伊可白滞素片 | Janssen-Cilag International NV | 2031-08-24 | 2031-02-24 |
| 国药准字HJ20170305 | Propofol 1% Fresenius 丙泊酚乳状注射液 | Fresenius Kabi Deutschland GmbH | 2031-08-25 | 2031-02-25 |
| 国药准字HJ20170306 | Propofol 1% Fresenius 丙泊酚乳状注射液 | Fresenius Kabi Deutschland GmbH | 2031-08-25 | 2031-02-25 |
| 国药准字HJ20170351 | Jardiance 恩格列净片 | Boehringer Ingelheim International GmbH | 2031-08-25 | 2031-02-25 |
| 国药准字HJ20170352 | Jardiance 恩格列净片 | Boehringer Ingelheim International GmbH | 2031-08-25 | 2031-02-25 |
| 国药准字HJ20160513 | LAMICTAL 拉莫三嗪片 | The Wellcome Foundation Limited | 2031-08-27 | 2031-02-27 |
| 国药准字HJ20160626 | LAMICTAL 拉莫三嗪片 | The Wellcome Foundation Limited | 2031-08-27 | 2031-02-27 |
| 国药准字HJ20171057 | Duphalac 乳果糖口服溶液 | Abbott B.V. | 2031-08-27 | 2031-02-27 |
| 国药准字HJ20210042 | Nitisinone Capsules 尼替西农胶囊 | MENDELIKABS INC | 2031-08-27 | 2031-02-27 |
| 国药准字HJ20210043 | Nitisinone Capsules 尼替西农胶囊 | MENDELIKABS INC | 2031-08-27 | 2031-02-27 |
| 国药准字HJ20210044 | Nitisinone Capsules 尼替西农胶囊 | MENDELIKABS INC | 2031-08-27 | 2031-02-27 |
| 国药准字HJ20170104 | Avamys 糠酸氟替卡松鼻用喷雾剂 | GlaxoSmithKline Trading Services Limited | 2031-08-31 | 2031-02-28 |
| 国药准字HJ20170105 | Avamys 糠酸氟替卡松鼻用喷雾剂 | GlaxoSmithKline Trading Services Limited | 2031-08-31 | 2031-02-28 |
| 国药准字HJ20171003 | Micardis 替米沙坦片 | Boehringer Ingelheim International GmbH | 2031-08-31 | 2031-02-28 |
| 国药准字HJ20171004 | Micardis 替米沙坦片 | Boehringer Ingelheim International GmbH | 2031-08-31 | 2031-02-28 |
| 国药准字HJ20171005 | Micardis 替米沙坦片 | Boehringer Ingelheim International GmbH | 2031-08-31 | 2031-02-28 |
| 国药准字HJ20171010 | Micardis 替米沙坦片 | Boehringer Ingelheim International GmbH | 2031-08-31 | 2031-02-28 |
| 国药准字HJ20171081 | Losartan Potassium Tablets 氯沙坦钾片 | Organon Pharma (UK) Limited | 2031-08-31 | 2031-02-28 |
| 国药准字HJ20171082 | Losartan Potassium Tablets 氯沙坦钾片 | Organon Pharma (UK) Limited | 2031-08-31 | 2031-02-28 |
| 国药准字HJ20171083 | Losartan Potassium Tablets 氯沙坦钾片 | Organon Pharma (UK) Limited | 2031-08-31 | 2031-02-28 |
| 国药准字HJ20171224 | Micardis 替米沙坦片 | Boehringer Ingelheim International GmbH | 2031-08-31 | 2031-02-28 |
| 国药准字HJ20171245 | Cozaar 氯沙坦钾片 | Organon Pharma (UK) Limited | 2031-08-31 | 2031-02-28 |
| 国药准字HJ20171246 | Cozaar 氯沙坦钾片 | Organon Pharma (UK) Limited | 2031-08-31 | 2031-02-28 |
| 国药准字HJ20171271 | Micardis 替米沙坦片 | Boehringer Ingelheim International GmbH | 2031-08-31 | 2031-02-28 |
| 国药准字HJ20202003 | Cozaar 氯沙坦钾片 | Organon Pharma (UK) Limited | 2031-08-31 | 2031-02-28 |
| 国药准字SJ20210029 | NUCALA 美泊利珠单抗注射液 | GlaxoSmithKline Trading Services Limited | 2031-08-31 | 2031-02-28 |
| 国药准字SJ20210030 | NUCALA 美泊利珠单抗注射液 | GlaxoSmithKline Trading Services Limited | 2031-08-31 | 2031-02-28 |
| 国药准字SJ20210034 | Kesimpta 奥法妥木单抗注射液 | Novartis Pharmaceuticals Corporation | 2031-08-31 | 2031-02-28 |
| 国药准字HJ20260075 | Etripamil Nasal Spray 艾曲帕米鼻喷雾剂 | Milestone Pharmaceuticals Inc. | 2031-09-01 | 2031-03-01 |
| 国药准字HJ20260076 | WAYRILZ 利扎布替尼片 | Genzyme Corporation | 2031-09-01 | 2031-03-01 |
| 国药准字HJ20260077 | TASFYGO 琥珀酸他舒替尼片 | Eisai Co., Ltd. | 2031-09-01 | 2031-03-01 |
| 国药准字SJ20260041 | Lecanemab Injection (Subcutaneous Injection) 仑卡奈单抗注射液（皮下注射） | Eisai Inc. | 2031-09-01 | 2031-03-01 |
| 国药准字HJ20160549 | INVEGA 帕利哌酮缓释片 | Janssen-Cilag International NV | 2031-09-02 | 2031-03-02 |
| 国药准字HJ20160550 | INVEGA 帕利哌酮缓释片 | Janssen-Cilag International NV | 2031-09-02 | 2031-03-02 |
| 国药准字HJ20160551 | INVEGA 帕利哌酮缓释片 | Janssen-Cilag International NV | 2031-09-02 | 2031-03-02 |
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