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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Shandong Xinhua Pharmaceutical

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01 Amidopyrine (1)

02 Aminophylline (1)

03 Amlodipine Besylate (1)

04 Amobarbital (1)

05 Aspirin (3)

06 Barbital Sodium (1)

07 Caffeine (1)

08 Calcium Carbonate (1)

09 Calcium Polycarbophil (1)

10 Carbidopa (1)

11 Enoxacin (1)

12 Etilevodopa (1)

13 Glimepiride (1)

14 Hydrocortisone (2)

15 Hydrocortisone Acetate (2)

16 Ibuprofen (2)

17 Ibuprofen Sodium (1)

18 Icosapent Ethyl (2)

19 Irisquinone (1)

20 Meloxicam (1)

21 Metamizole (1)

22 Metamizole Magnesium (1)

23 Metol (1)

24 Nimodipine (1)

25 Omega-3-Acid Ethyl Esters 90 (1)

26 Phenazon (1)

27 Phenobarbital (1)

28 Pipemidic Acid (1)

29 Piperidin-1-Yl-Acetic Acid (1)

30 Prednisolone (1)

31 Prednisone (1)

32 Prednisone Acetate (1)

33 Propyphenazone (1)

34 Sevelamer Carbonate (1)

35 Sumatriptan (1)

36 Theophylline (2)

37 Tramadol Hydrochloride (1)

38 Trimethoprim (1)

39 Blank (1)

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01 Active (23)

02 Inactive (6)

03 Blank (17)

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01 Valid (13)

02 Blank (33)

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01 217MF10482 (1)

02 219MF10215 (1)

03 221MF10029 (1)

04 221MF10201 (1)

05 227MF10242 (1)

06 301MF10007 (1)

07 303MF10169 (1)

08 305MF10044 (1)

09 Blank (38)

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01 Blank (46)

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USDMF

Found USDMF

13092
Active
CAFFEINE ANHYDROUS
1998-07-10
CEP/COS

Found CEP/COS

R1-CEP 2003-027 - Rev 03
Valid
Caffeine
2015-08-24
Japanese DMF

Found JDMF

301MF10007
Japanese Pharmacopoeia Anhydrous Ca...
2019-05-27
Written Confirmation

Close WC

Application Number
13092
301MF10007
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
CAFFEINE ANHYDROUS
Caffeine
Japanese Pharmacopoeia Anhydrous Ca...
Issue/Submission Date
1998-07-10
2015-08-24
2019-05-27
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USDMF

Found USDMF

27430
Active
CARBIDOPA
2013-07-23
CEP/COS

Found CEP/COS

R1-CEP 2016-052 - Rev 00
Valid
Carbidopa
2022-04-20
Japanese DMF

Found JDMF

227MF10242
Japanese Pharmacopoeia carbidopa hy...
2015-10-07
Written Confirmation

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Application Number
27430
227MF10242
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
CARBIDOPA
Carbidopa
Japanese Pharmacopoeia carbidopa hy...
Issue/Submission Date
2013-07-23
2022-04-20
2015-10-07
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USDMF

Found USDMF

22598
Active
LEVODOPA
2009-03-05
CEP/COS

Found CEP/COS

R1-CEP 2009-174 - Rev 02
Valid
Levodopa
2022-04-11
Japanese DMF

Found JDMF

221MF10029
Japanese Pharmacopoeia levodopa (pr...
2009-02-09
Written Confirmation

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Application Number
22598
221MF10029
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
LEVODOPA
Levodopa
Japanese Pharmacopoeia levodopa (pr...
Issue/Submission Date
2009-03-05
2022-04-11
2009-02-09
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USDMF

Found USDMF

4633
Active
THEOPHYLLINE
1982-07-28
CEP/COS

Found CEP/COS

R1-CEP 1998-004 - Rev 07
Valid
Theophylline
2017-02-02
Japanese DMF

Found JDMF

217MF10482
Japanese Pharmacopoeia theophylline...
2005-09-06
Written Confirmation

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Application Number
4633
217MF10482
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
THEOPHYLLINE
Theophylline
Japanese Pharmacopoeia theophylline...
Issue/Submission Date
1982-07-28
2017-02-02
2005-09-06
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USDMF

Found USDMF

10730
Active
ASPIRIN
1994-01-20
CEP/COS

Found CEP/COS

R1-CEP 2001-210 - Rev 05
Valid
Acetylsalicylic acid
2016-11-14
Japanese DMF

Close JDMF

Written Confirmation

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Application Number
10730
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
ASPIRIN
Acetylsalicylic acid
Issue/Submission Date
1994-01-20
2016-11-14
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USDMF

Found USDMF

32319
Active
GLIMEPIRIDE
2017-11-22
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

303MF10169
Glimepiride at No. 1, Lutai Road, H...
2021-11-25
Written Confirmation

Close WC

Application Number
32319
303MF10169
Status
Active
Fees Paid
N/A
 
Filing Details
GLIMEPIRIDE
Glimepiride at No. 1, Lutai Road, H...
Issue/Submission Date
2017-11-22
2021-11-25
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USDMF

Found USDMF

34361
Active
ETHYL ICOSAPENTATE 98
2020-03-10
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

305MF10044
ETHYL ICOSAPENTATE at No. 1, Lutai ...
2023-04-05
Written Confirmation

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Application Number
34361
305MF10044
Status
Active
Fees Paid
Reviewed
 
Filing Details
ETHYL ICOSAPENTATE 98
ETHYL ICOSAPENTATE at No. 1, Lutai ...
Issue/Submission Date
2020-03-10
2023-04-05
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USDMF

Found USDMF

31035
Active
DIPYRONE (METAMIZOLE SODIUM MONOHYD...
2016-10-19
CEP/COS

Found CEP/COS

R1-CEP 2001-356 - Rev 04
Valid
Metamizole sodium monohydrate
2017-08-11
Japanese DMF

Close JDMF

Written Confirmation

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Application Number
31035
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
DIPYRONE (METAMIZOLE SODIUM MONOHYD...
Metamizole sodium monohydrate
Issue/Submission Date
2016-10-19
2017-08-11
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USDMF

Found USDMF

27827
Active
PHENOBARBITAL
2013-12-01
CEP/COS

Found CEP/COS

CEP 2017-269 - Rev 01
Valid
Phenobarbital
2023-11-03
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
27827
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
PHENOBARBITAL
Phenobarbital
Issue/Submission Date
2013-12-01
2023-11-03
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USDMF

Found USDMF

13144
Active
TRIMETHOPRIM USP
1998-08-18
CEP/COS

Found CEP/COS

R1-CEP 2003-195 - Rev 04
Valid
Trimethoprim
2015-08-24
Japanese DMF

Close JDMF

Written Confirmation

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Application Number
13144
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
TRIMETHOPRIM USP
Trimethoprim
Issue/Submission Date
1998-08-18
2015-08-24
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