山东安信制药有限公司

Shandong Anxin Pharmaceutical Co. Ltd.

Country: CN CDE+DMF+CEP VERY_HIGH

🇨🇳 CDE

35

35 products shown

🇺🇸 DMF

19

19 products shown

🇪🇺 CEP

13

13 products shown

Total

67

registrations

🇨🇳 CDE 注册 (35)

Product CAS Status Reg Number
Amikacin

阿米卡星

37517-28-5 Class A Y20190001593
Amikacin Sulfate

硫酸阿米卡星

39831-55-5 Class A Y20190001575
Ampicillin Sodium

氨苄西林钠

69-53-4 Class A Y20190001541
Aprepitant

阿瑞匹坦

170729-80-3 Class A Y20180001363
Capecitabine

卡培他滨

154361-50-9 Class A Y20190008885
Carmofur

卡莫氟

61422-45-5 Class A Y20190001534
Celecoxib

塞来昔布

169590-42-5 Class A Y20170000772
Decitabine

地西他滨

2353-33-5 Class I Y20240000263
Docetaxel

多西他赛

114977-28-5 Class I Y20250000074
Escitalopram Oxalate

草酸艾司西酞普兰

59729-33-8 Class A Y20190008896
Etoricoxib

依托考昔

202409-33-4 Class A Y20170001901
Evt-101

阿普唑仑

1189088-41-2 Class A Y20190001538
Fosaprepitant Dimeglumine

福沙匹坦双葡甲胺

170729-80-3 Class A Y20180001076
Hydroxycarbamide

过氧化碳酰胺

57-13-6 Class A Y20190001536
Ibrutinib

伊布替尼

936563-96-1 Class A Y20230000290
Imatinib

硫酸艾玛昔替尼

152459-95-5 Class A Y20190021643
Imatinib

硫酸艾玛昔替尼

152459-95-5 Class I Y20180000974
Lenvatinib

甲磺酸仑伐替尼

417716-92-8 Class A Y20190021453
Montelukast Sodium

孟鲁司特钠

158966-92-8 Class A Y20170001337
Olmesartan Medoxomil

奥美沙坦酯

144689-63-4 Class A Y20170000202
Piperacillin Sodium

哌拉西林钠

61477-96-1 Class A Y20190009502
Piperacillin Sodium

哌拉西林钠

61477-96-1 Class A Y20170000228
Ponatinib

盐酸泊那替尼

943319-70-8 Class I Y20250000177
Quetiapine

富马酸喹硫平

111974-69-7 Class A Y20170000460
Tadalafil

他达拉非

171596-29-5 Class A Y20180001768
Tazobactam

他唑巴坦

89786-04-9 Class A Y20190008388
Tazobactam Sodium

他唑巴坦钠

89786-04-9 Class I Y20250000214
Tazobactam Sodium

他唑巴坦钠

89786-04-9 Class A Y20190002975
Tegafur

替加氟

17902-23-7 Class A Y20190001537
Ticarcillin Sodium

替卡西林钠

- Class A Y20170000799
Tipiracil

盐酸替匹嘧啶

- Class A Y20180001365
Tofacitinib

伊托法替布

477600-75-2 Class A Y20180001747
Trazodone

盐酸曲唑酮

19794-93-5 Class I Y20250000875
Trifluridine, Combinations

曲氟尿苷

- Class A Y20180001364
Uracil

尿嘧啶

66-22-8 Class A Y20190001533

🇺🇸 DMF 注册 (19)

Product CAS DMF Number Date
Amikacin Sulfate USP, Non-sterile Active Pharmaceutical Ingredient 39831-55-5 - 2007-09-18
Aprepitant (non-sterile Api)

阿瑞匹坦

170729-80-3 - 2024-03-29
Capecitabine (non-sterile Api)

卡培他滨

154361-50-9 - 2010-12-31
Fosaprepitant Dimeglumine (non-sterile Api)

福沙匹坦

265121-04-8 - 2018-11-30
Hydroxyurea USP (non-sterile Bulk) 127-07-1 - 2007-06-15
Imatinib Mesylate (non-sterile Api) 220127-57-1 - 2015-08-27
Olmesartan Medoxomil USP (non-sterile, Active Pharmaceutical Ingredient)

奥美沙坦酯

144689-63-4 - 2015-08-21
Piperacillin (non-sterile Api)

哌拉西林

61477-96-1 - 2012-03-01
Piperacillin Sodium And Tazobactam Sodium (8:1) - - 2007-04-09
Piperacillin Sodium And Tazobactam Sodium (8:1) (process Iv) - - 2019-02-21
Piperacillin Sodium And Tazobactam Sodium (8:1) (sterile Api) - - 2012-03-21
Piperacillin USP (non-sterile Api)

哌拉西林

61477-96-1 - 2019-05-31
Sulbactam Sodium (non-sterile Api) 69388-84-7 - 2015-03-31
Tadalafil

他达拉非

171596-29-5 - 2019-04-11
Tazobactam (non-sterile Api)

他唑巴坦

89786-04-9 - 2019-07-17
Tazobactam (triazole Process)

他唑巴坦

89786-04-9 - 2022-05-23
Tazobactam Acid (process I, Non-sterile Bulk)

他唑巴坦

89786-04-9 - 2007-04-05
Tazobactam Sodium (sterile Api)

他唑巴坦 钠

89785-84-2 - 2011-01-29
Tofacitinib Citrate (non-sterile Api) 540737-29-9 - 2016-06-13

🇪🇺 CEP 注册 (13)

Product CAS CEP Number Date
Amikacin Sulfate

硫酸阿米卡星

39831-55-5 CEP 2010-308 - Rev 02 -
Azithromycin Dihydrate

阿奇霉素枸橼酸二氢钠

117772-70-0 CEP 2025-033 - Rev 00 -
Capecitabine

卡培他滨

154361-50-9 CEP 2014-189 - Rev 04 -
Celecoxib

塞来昔布

169590-42-5 R1-CEP 2015-297 - Rev 01 -
Docetaxel Trihydrate, Shandong Anxin Site 148408-66-6 CEP 2025-133 - Rev 00 -
Hydroxycarbamide

过氧化碳酰胺

57-13-6 CEP 2005-051 - Rev 05 -
Imatinib Mesilate 220127-57-1 R1-CEP 2016-039 - Rev 00 -
Imatinib Mesilate, Β Form, Milled, Non-milled 220127-57-1 CEP 2017-292 - Rev 04 -
Olmesartan Medoxomil

奥美沙坦酯

144689-63-4 R1-CEP 2014-225 - Rev 00 -
Piperacillin Monohydrate

哌拉西林

66258-76-2 R1-CEP 2015-389 - Rev 00 -
Piperacillin Sodium, Sterile

哌拉西林 钠

59703-84-3 CEP 2024-333 - Rev 00 -
Quetiapine Fumarate

富马酸喹硫平

111974-72-2 R0-CEP 2015-080 - Rev 01 -
Tadalafil

他达拉非

171596-29-5 R1-CEP 2016-001 - Rev 00 -

Source: cde+fda_direct; DMF高置信 | Updated: 2026-04-09 07:23:01