国为医药 国为生物

序号

药物名称

API

CAS号

CDE状态

质量标准

注册文件

1

贝前列素钠

Beraprost Sodium

88475-69-8

A

Y20220001281

JP/In-House

Local GMP

DMF

2

环硅酸锆钠

Sodium Zirconium Cyclosilicate

242800-27-7

/

In-House

3

替普瑞酮

Teprenone

6809-52-5

A

Y20220000193

JP/In-House

Local GMP

DMF

4

ω-3脂肪酸乙酯90

Omega-3-acid Ethyl Ester 90

/

A

Y20190001013

EP/USP

Local GMP

CEP/US-DMF(In-Process)

5

二十碳五烯酸乙酯

Icosapent Ethyl

86227-47-6

A

Y20210000213

JP/In-House

Local GMP

US-DMF

6

精制橄榄油

Refined Olive Oil

8001-25-0

A

Y20210001207

EP/USP

Local GMP

DMF/CEP(In-Process)

7

鱼油(28% ω-3酸）

Fish Oil (28% Omega-3 Acids)

8016-13-5

A

Y20230000280

In-House

DMF/CEP(In-Process)

8

结构甘油三脂

Structured Triglycerides

/

I

Y20250000059

In-House

DMF

9

鱼油甘油三酸酯

Fish Oil Triglycerides

/

A

Y20210001075

In-House

Local GMP

DMF

10

ω-3 脂肪酸甘油三酯

Omega-3-acid

Triglycerides

/

/

In-House

/

11

盐酸莫西沙星

Moxifloxacin Hydrochloride

186826-86-8

A

Y20190009766/Y20190000446

EP/USP

Local GMP

DMF /CEP(In-Process)

12

蔗糖羟基氧化铁

Sucroferric Oxyhydroxide

8047-67-4

I

Y20250000537

In-House

DMF/US-DMF(In-Process)

13

异麦芽糖酐铁

Ferric Derisomaltose

1345510-43-1

/

In-House

/

14

吗啉硝唑

Morinidazole

92478-27-8

A

Y20220000050

In-House

Local GMP

DMF

15

乌帕替尼

Upadacitinib

1310726-60-3

A

Y20230001341

In-House

US-DMF

16

骨化三醇

Calcitriol

32222-06-3

A

Y20200000975

EP/USP

Local GMP

DMF

17

艾地骨化醇

Eldecalcitol

104121-92-8

A

Y20210000439

In-House

Local GMP

DMF

18

帕立骨化醇

Paricalcitol

131918-61-1

A

Y20170001198

USP

Local GMP

DMF

19

阿戈美拉汀

Agomelatine

138112-76-2

A

Y20230000472

In-House

DMF

20

度他雄胺

Dutasteride

164656-23-9

A

Y20210001214

EP/USP

Local GMP

DMF

21

艾拉莫德

Iguratimod

123663-49-0

I

Y20240000438

In-House

DMF

22

利那洛肽

Linaclotide

851199-59-2

I

Y20240000603

In-House

DMF/US-DMF(In-Process)

23

塞来昔布

Celecoxib

169590-42-5

A

Y20180001644

EP/USP

Local GMP

DMF

24

达格列净

Dapagliflozin

461432-26-8

A

Y20210000979

USP

DMF

25

利奈唑胺

Linezolid

A

Y20220000794

USP

DMF

26

精氨酸培哚普利

Perindopril L-Arginine

612548-45-5

I

Y20250000010

EP

DMF

27

罗沙司他

Roxadustat

808118-40-3

A

Y20230001147

In-House

DMF

28

琥珀酸索利那新

Solifenacin Succinate

242478-38-2

A

Y20170001548

EP

Local GMP

DMF

29

多替诺雷

Dotinurad

1285572-51-1

/

In-House

DMF

30

艾普拉唑

Ilaprazole

172152-36-2

/

In-House

DMF

31

鲁比前列酮

Lubiprostone

333963-40-9

/

In-House

DMF

32

标准桃金娘油

Myrtle Oil

8008-46-6

/

In-House

DMF

琥珀酰明胶

Succinylateol Gelatin

68915-24-2

/

In-House

DMF

I

Y20250000065

中间体

Intermediate

1

GalNAc（L96)

/

In-House

/