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Renejix CDMO Partner for Small Molecule Oral Dosage Forms Renejix CDMO Partner for Small Molecule Oral Dosage Forms

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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Sanum-kehlbeck Gmbh & Co. Kg

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01 Adenine (1)

02 Alprostadil (1)

03 Amantadine Hydrochloride (1)

04 Arginine Vasopressin (1)

05 Azacitidine (1)

06 Azithromycin (1)

07 Bendamustine Hydrochloride (1)

08 Bromazepam (1)

09 Calcitonin (1)

10 Calcium Polystyrene Sulfonate (1)

11 Carboprost Tromethamine (1)

12 Cholestyramine (1)

13 Decitabine (1)

14 Degarelix Acetate (1)

15 Desmopressin Acetate (2)

16 Etelcalcetide (1)

17 Ganirelix (1)

18 Glatiramer Acetate (1)

19 Icatibant Acetate (1)

20 Lansoprazole (1)

21 Leuprolide Acetate (1)

22 Levofloxacin (1)

23 Linaclotide (1)

24 Liraglutide (1)

25 Methacrylic Acid (1)

26 Moxifloxacin Hydrochloride (1)

27 Octreotide Acetate (1)

28 Paroxetine Hydrochloride (1)

29 Pemetrexed Disodium (1)

30 Plecanatide (1)

31 Pregabalin (1)

32 Risedronate Sodium (1)

33 Rosiglitazone Maleate (1)

34 Rosuvastatin Calcium (1)

35 Sodium Polystyrene Sulfonate (1)

36 Temozolomide (1)

37 Teriparatide (1)

38 Tolterodine Tartrate (1)

39 Treprostinil Diolamine (1)

40 Blank (3)

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01 Active (22)

02 Inactive (11)

03 Blank (10)

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01 Valid (1)

02 Withdrawn by Holder (1)

03 Blank (41)

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01 230MF10118 (1)

02 301MF10031 (1)

03 Blank (41)

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01 WC-0352 (4)

02 WC-0443 (2)

03 WC-0443-A1-2 (3)

04 Blank (34)

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USDMF

Found USDMF

30233
Active
DESMOPRESSIN ACETATE USP
2016-02-19
CEP/COS

Found CEP/COS

R1-CEP 2016-125 - Rev 01
Valid
Desmopressin
2023-03-31
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0443
Expired
Desmopressin Acetate USP at 4th Flo...
2019-06-11
Application Number
30233
Indian CDSCO WC-0443
Status
Active
Fees Unpaid
Reviewed
Valid
 
Expired
2022-06-11
Filing Details
DESMOPRESSIN ACETATE USP
Desmopressin
Desmopressin Acetate USP at 4th Flo...
Issue/Submission Date
2016-02-19
2023-03-31
2019-06-11
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USDMF

Found USDMF

31170
Active
LEUPROLIDE ACETATE USP
2016-11-30
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0443-A1-2
Expired
Leuprolide Acetate IH at 4th Floor,...
2022-06-10
Application Number
31170
Indian CDSCO WC-0443-A1-2
Status
Active
Fees Unpaid
Reviewed
 
Expired
2019-07-22
Filing Details
LEUPROLIDE ACETATE USP
Leuprolide Acetate IH at 4th Floor,...
Issue/Submission Date
2016-11-30
2022-06-10
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USDMF

Found USDMF

29708
Active
LINACLOTIDE
2015-09-22
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0443-A1-2
Expired
Linaclotide IH at 4th Floor, Survey...
2022-06-10
Application Number
29708
Indian CDSCO WC-0443-A1-2
Status
Active
Fees Unpaid
Reviewed
 
Expired
2019-07-22
Filing Details
LINACLOTIDE
Linaclotide IH at 4th Floor, Survey...
Issue/Submission Date
2015-09-22
2022-06-10
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USDMF

Found USDMF

29448
Active
OCTREOTIDE ACETATE
2015-06-20
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0443
Expired
Octreotide Acetate IH at 4th Floor,...
2019-06-11
Application Number
29448
Indian CDSCO WC-0443
Status
Active
Fees Unpaid
Reviewed
 
Expired
2022-06-11
Filing Details
OCTREOTIDE ACETATE
Octreotide Acetate IH at 4th Floor,...
Issue/Submission Date
2015-06-20
2019-06-11
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USDMF

Found USDMF

34239
Active
ALPROSTADIL
2020-04-21
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
34239
Status
Active
Fees Unpaid
N/A
 
Filing Details
ALPROSTADIL
Issue/Submission Date
2020-04-21
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USDMF

Found USDMF

33119
Active
VASOPRESSIN USP
2018-08-27
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
33119
Status
Active
Fees Unpaid
Reviewed
 
Filing Details
VASOPRESSIN USP
Issue/Submission Date
2018-08-27
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USDMF

Found USDMF

27953
Active
AZACYTIDINE
2014-03-18
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
27953
Status
Active
Fees Paid
Reviewed
 
Filing Details
AZACYTIDINE
Issue/Submission Date
2014-03-18
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USDMF

Found USDMF

35791
Active
CALCITONIN SALMON USP
2021-03-30
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
35791
Status
Active
Fees Unpaid
Reviewed
 
Filing Details
CALCITONIN SALMON USP
Issue/Submission Date
2021-03-30
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USDMF

Found USDMF

36373
Active
CARBOPROST TROMETHAMINE
2021-10-14
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
36373
Status
Active
Fees Unpaid
N/A
 
Filing Details
CARBOPROST TROMETHAMINE
Issue/Submission Date
2021-10-14
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USDMF

Found USDMF

26708
Active
DECITABINE
2012-12-11
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
26708
Status
Active
Fees Paid
Reviewed
 
Filing Details
DECITABINE
Issue/Submission Date
2012-12-11
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