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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Porton Pharma Solutions

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01 Abemaciclib (1)

02 Alectinib Hydrochloride (1)

03 Apalutamide (1)

04 Baloxavir Marboxil (1)

05 Cariprazine Hydrochloride (1)

06 Crisaborole (1)

07 Dapagliflozin (1)

08 Dexrazoxane (1)

09 Empagliflozin (1)

10 Hydroxychloroquine Sulphate (1)

11 Isavuconazonium Sulfate (1)

12 Mefloquine (1)

13 Methotrexate (1)

14 Nicotine (2)

15 Niraparib Tosylate (1)

16 Palbociclib (1)

17 Phloroglucinol (1)

18 Relugolix (1)

19 Rimegepant Sulfate (1)

20 Ruxolitinib Phosphate (1)

21 Salmeterol Xinafoate (1)

22 Sulfanilamide (1)

23 Tiopronin (1)

24 Trimethyl Phloroglucinol (1)

25 Vonoprazan Fumarate (1)

26 Blank (1)

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01 Active (9)

02 Blank (18)

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01 Valid (1)

02 Blank (26)

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01 Blank (27)

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01 Blank (27)

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USDMF

Found USDMF

26541
Active
NICOTINE USP
2012-10-03
CEP/COS

Found CEP/COS

R1-CEP 2012-386 - Rev 00
Valid
Nicotine
2019-03-11
Japanese DMF

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Written Confirmation

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Application Number
26541
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
NICOTINE USP
Nicotine
Issue/Submission Date
2012-10-03
2019-03-11
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USDMF

Found USDMF

39029
Active
APALUTAMIDE
2023-11-02
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
39029
Status
Active
Fees Paid
N/A
 
Filing Details
APALUTAMIDE
Issue/Submission Date
2023-11-02
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USDMF

Found USDMF

39028
Active
DAPAGLIFLOZIN
2023-10-16
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
39028
Status
Active
Fees Paid
N/A
 
Filing Details
DAPAGLIFLOZIN
Issue/Submission Date
2023-10-16
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USDMF

Found USDMF

38186
Active
DEXRAZOXANE
2023-03-17
CEP/COS

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Japanese DMF

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Application Number
38186
Status
Active
Fees Paid
N/A
 
Filing Details
DEXRAZOXANE
Issue/Submission Date
2023-03-17
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USDMF

Found USDMF

38020
Active
NICOTINE (SYNTHETIC)
2023-02-10
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
38020
Status
Active
Fees Paid
N/A
 
Filing Details
NICOTINE (SYNTHETIC)
Issue/Submission Date
2023-02-10
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USDMF

Found USDMF

37070
Active
SALMETEROL XINAFOATE API
2022-05-23
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
37070
Status
Active
Fees Paid
N/A
 
Filing Details
SALMETEROL XINAFOATE API
Issue/Submission Date
2022-05-23
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USDMF

Found USDMF

35714
Active
DN SULFONAMIDE
2021-05-19
CEP/COS

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Japanese DMF

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Application Number
35714
Status
Active
Fees Paid
N/A
 
Filing Details
DN SULFONAMIDE
Issue/Submission Date
2021-05-19
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USDMF

Found USDMF

29447
Active
TIOPRONIN NON-STERILE BULK DRUG
2015-06-01
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
29447
Status
Active
Fees Paid
N/A
 
Filing Details
TIOPRONIN NON-STERILE BULK DRUG
Issue/Submission Date
2015-06-01
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ISAVUCONAZONIUM SULFATE API, NON-STERILE DRUG SUBSTANCE

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USDMF

Found USDMF

39012
Active
ISAVUCONAZONIUM SULFATE API, NON-ST...
2023-11-10
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
39012
Status
Active
Fees Paid
N/A
 
Filing Details
ISAVUCONAZONIUM SULFATE API, NON-ST...
Issue/Submission Date
2023-11-10
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
Status
 
Filing Details
Issue/Submission Date
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