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

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01 Afoxolaner (1)

02 Alectinib Hydrochloride (1)

03 Apalutamide (1)

04 Articaine Hydrochloride (1)

05 Baloxavir Marboxil (1)

06 Brexanolone (1)

07 Brinzolamide (1)

08 Bupivacaine (1)

09 Bupivacaine Hydrochloride (1)

10 Celecoxib (1)

11 Cinchocaine Hydrochloride (1)

12 Crisaborole (1)

13 Dapagliflozin (1)

14 Dexmedetomidine Hydrochloride (1)

15 Donepezil (1)

16 Dyclonine (1)

17 Emoxypine Succinate (1)

18 Fexuprazan (1)

19 Finerenone (1)

20 Fluralaner (1)

21 Letermovir (1)

22 Levobupivacaine (1)

23 Lidocaine (1)

24 Lidocaine Hydrochloride (1)

25 Lotilaner (1)

26 Meldonium (1)

27 Mepivacaine Hydrochloride (1)

28 Metoclopramide (1)

29 Molnupiravir (1)

30 Nadifloxacin (1)

31 Ozagrel Sodium (1)

32 Ozenoxacin (1)

33 Pramoxine Hydrochloride (1)

34 Prilocaine (1)

35 Prilocaine Hydrochloride (1)

36 Remdesivir (1)

37 Resmetirom (1)

38 Ropivacaine Hydrochloride (1)

39 Ropivacaine Mesylate (1)

40 Ruxolitinib Phosphate (1)

41 Sarolaner (1)

42 Sugammadex Sodium (1)

43 Tadalafil (1)

44 Terbinafine Hydrochloride (1)

45 Tetracaine (1)

46 Tetracaine Hydrochloride (1)

47 Upadacitinib (1)

48 Urolithin A (1)

49 Vonoprazan Fumarate (1)

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01 Active (4)

02 Blank (45)

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01 Valid (1)

02 Blank (48)

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01 Blank (49)

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01 SD220008 (1)

02 SD220029 (1)

03 SD230027 (1)

04 SD230030 (1)

05 SD230036 (1)

06 SD230069 (1)

07 SD230070 (1)

08 SD240003 (1)

09 Blank (41)

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USDMF

Found USDMF

39107
Active
VONOPRAZAN FUMARATE
2023-11-02
CEP/COS

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Japanese DMF

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Written Confirmation

Found WC

SD240003
Valid
Vonoprazan Fumarate at Economic Dev...
2024-01-15
Application Number
39107
SD240003
Status
Active
Fees Unpaid
N/A
 
Valid
2027-01-14
Filing Details
VONOPRAZAN FUMARATE
Vonoprazan Fumarate at Economic Dev...
Issue/Submission Date
2023-11-02
2024-01-15
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

Found WC

SD230070
Valid
Celecoxib at Economic Development Z...
2023-11-06
Application Number
SD230070
Status
 
Valid
2026-11-05
Filing Details
Celecoxib at Economic Development Z...
Issue/Submission Date
2023-11-06
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

Found WC

SD230027
Valid
Lidocaine at Economic Development Z...
2023-03-29
Application Number
SD230027
Status
 
Valid
2026-03-28
Filing Details
Lidocaine at Economic Development Z...
Issue/Submission Date
2023-03-29
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

Found WC

SD220008
Valid
Lidocaine HCl at Economic Developme...
2022-02-07
Application Number
SD220008
Status
 
Valid
2025-02-08
Filing Details
Lidocaine HCl at Economic Developme...
Issue/Submission Date
2022-02-07
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USDMF

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CEP/COS

Found CEP/COS

R0-CEP 2022-113 - Rev 00
Valid
Meldonium dihydrate
2023-08-21
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Meldonium dihydrate
Issue/Submission Date
2023-08-21
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USDMF

Found USDMF

37519
Active
Pramoxine Hydrochloride
2022-09-15
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
37519
Status
Active
Fees Unpaid
N/A
 
Filing Details
Pramoxine Hydrochloride
Issue/Submission Date
2022-09-15
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

Found WC

SD220029
Valid
Prilocaine at Economic Development ...
2022-11-15
Application Number
SD220029
Status
 
Valid
2025-11-14
Filing Details
Prilocaine at Economic Development ...
Issue/Submission Date
2022-11-15
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USDMF

Found USDMF

34701
Active
PRILOCAINE HYDROCHLORIDE
2020-03-30
CEP/COS

Close CEP/COS

Japanese DMF

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Written Confirmation

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Application Number
34701
Status
Active
Fees Unpaid
N/A
 
Filing Details
PRILOCAINE HYDROCHLORIDE
Issue/Submission Date
2020-03-30
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

Found WC

SD230036
Valid
Ropivacaine Hydrochloride at Econom...
2023-05-30
Application Number
SD230036
Status
 
Valid
2026-05-29
Filing Details
Ropivacaine Hydrochloride at Econom...
Issue/Submission Date
2023-05-30
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

Found WC

SD230030
Valid
Sugammadex Sodium at Economic Devel...
2023-04-07
Application Number
SD230030
Status
 
Valid
2026-04-06
Filing Details
Sugammadex Sodium at Economic Devel...
Issue/Submission Date
2023-04-07
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