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Athena Athena

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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Alkem Laboratories Ltd

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01 Amlodipine (1)

02 Amlodipine Besylate (2)

03 Apixaban (1)

04 Apremilast (1)

05 Aripiprazole (1)

06 Azilsartan (1)

07 Bempedoic Acid (1)

08 Benzoyl Peroxide (1)

09 Bupropion Hydrochloride (1)

10 CAS 21409-26-7 (1)

11 Canagliflozin (1)

12 Candesartan (1)

13 Cannabidiol (1)

14 Dabigatran Etexilate Mesylate (1)

15 Dapagliflozin (1)

16 Dexmethylphenidate (1)

17 Dimethyl Fumarate (1)

18 Dronedarone Hydrochloride (1)

19 Duloxetine (2)

20 Edoxaban Tosylate (1)

21 Eluxadoline (1)

22 Empagliflozin (1)

23 Esketamine Hydrochloride (1)

24 Eslicarbazepine (1)

25 Esomeprazole Magnesium (2)

26 Ezetimibe (1)

27 Fampridine (1)

28 Isavuconazonium Sulfate (1)

29 Ivacaftor (1)

30 Lamotrigine (1)

31 Lansoprazole (2)

32 Lanthanum Carbonate (1)

33 Lercanidipine (1)

34 Lisdexamfetamine Dimesylate (2)

35 Lurasidone Hydrochloride (1)

36 Mesalazine (1)

37 Methylphenidate Hydrochloride (1)

38 Minoxidil (1)

39 Nebivolol (1)

40 Olanzapine (1)

41 Olmesartan Medoxomil (1)

42 Paliperidone (2)

43 Quetiapine Hemifumarate (1)

44 Rabeprazole (1)

45 Rasagiline Mesylate (2)

46 Riluzole (2)

47 Ritalinic Acid (1)

48 Rizatriptan Benzoate (2)

49 Sitagliptin Phosphate (1)

50 Sodium Oxybate (1)

51 Solifenacin Succinate (1)

52 Solriamfetol Hydrochloride (1)

53 Tapentadol (2)

54 Tolterodine Tartrate (1)

55 Tolvaptan (1)

56 Blank (1)

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01 Active (36)

02 Inactive (2)

03 Blank (28)

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01 Blank (66)

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01 Blank (66)

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01 WC-0370 (10)

02 WC-0370A3 (2)

03 WC-037a1 (6)

04 WC-0385 (2)

05 Blank (46)

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USDMF

Found USDMF

29703
Active
AMLODIPINE BESYLATE USP
2015-09-28
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0370
Valid
Amlodipine Besylate (USP)
2022-09-30
Application Number
29703
Indian CDSCO WC-0370
Status
Active
Fees Paid
Reviewed
 
Valid
2025-06-05
Filing Details
AMLODIPINE BESYLATE USP
Amlodipine Besylate (USP)
Issue/Submission Date
2015-09-28
2022-09-30
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USDMF

Found USDMF

24685
Active
DULOXETINE HYDROCHLORIDE
2011-03-17
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0370
Valid
Duloxetine Hydrochlorde USP
2022-09-30
Application Number
24685
Indian CDSCO WC-0370
Status
Active
Fees Paid
N/A
 
Valid
2025-06-05
Filing Details
DULOXETINE HYDROCHLORIDE
Duloxetine Hydrochlorde USP
Issue/Submission Date
2011-03-17
2022-09-30
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USDMF

Found USDMF

27637
Active
DALFAMPRIDINE USP
2013-11-01
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0370
Valid
Dalfampridine IH
2022-09-30
Application Number
27637
Indian CDSCO WC-0370
Status
Active
Fees Paid
Reviewed
 
Valid
2025-06-05
Filing Details
DALFAMPRIDINE USP
Dalfampridine IH
Issue/Submission Date
2013-11-01
2022-09-30
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USDMF

Found USDMF

25152
Active
LANSOPRAZOLE USP
2011-07-29
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0370
Valid
Lansoprazole (USP)
2022-09-30
Application Number
25152
Indian CDSCO WC-0370
Status
Active
Fees Paid
N/A
 
Valid
2025-06-05
Filing Details
LANSOPRAZOLE USP
Lansoprazole (USP)
Issue/Submission Date
2011-07-29
2022-09-30
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USDMF

Found USDMF

23679
Active
RASAGILINE MESYLATE
2010-04-26
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0370
Valid
Rasagiline Mesylate (IH)
2022-09-30
Application Number
23679
Indian CDSCO WC-0370
Status
Active
Fees Paid
N/A
 
Valid
2025-06-05
Filing Details
RASAGILINE MESYLATE
Rasagiline Mesylate (IH)
Issue/Submission Date
2010-04-26
2022-09-30
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USDMF

Found USDMF

25260
Active
RILUZOLE USP
2011-09-24
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0370
Valid
Riluzole USP
2022-09-30
Application Number
25260
Indian CDSCO WC-0370
Status
Active
Fees Paid
N/A
 
Valid
2025-06-05
Filing Details
RILUZOLE USP
Riluzole USP
Issue/Submission Date
2011-09-24
2022-09-30
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USDMF

Found USDMF

24884
Active
RIZATRIPTAN BENZOATE USP
2011-05-06
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0370
Valid
Rizatriptan Benzoate USP
2022-09-30
Application Number
24884
Indian CDSCO WC-0370
Status
Active
Fees Paid
N/A
 
Valid
2025-06-05
Filing Details
RIZATRIPTAN BENZOATE USP
Rizatriptan Benzoate USP
Issue/Submission Date
2011-05-06
2022-09-30
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USDMF

Found USDMF

28289
Active
SODIUM OXYBATE
2014-06-19
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0370
Valid
Sodium Oxybate IH
2022-09-30
Application Number
28289
Indian CDSCO WC-0370
Status
Active
Fees Paid
Reviewed
 
Valid
2025-06-05
Filing Details
SODIUM OXYBATE
Sodium Oxybate IH
Issue/Submission Date
2014-06-19
2022-09-30
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USDMF

Found USDMF

26519
Active
TAPENTADOL HYDROCHLORIDE
2012-10-23
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0370
Valid
Tapentadole Hydrochloride (IH)
2022-09-30
Application Number
26519
Indian CDSCO WC-0370
Status
Active
Fees Paid
Reviewed
 
Valid
2025-06-05
Filing Details
TAPENTADOL HYDROCHLORIDE
Tapentadole Hydrochloride (IH)
Issue/Submission Date
2012-10-23
2022-09-30
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USDMF

Found USDMF

27909
Active
ARIPIPRAZOLE USP
2014-02-13
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0385
Expired
Aripiprazole  (USP/EP)
2020-03-13
Application Number
27909
Indian CDSCO WC-0385
Status
Active
Fees Paid
Reviewed
 
Expired
2022-09-05
Filing Details
ARIPIPRAZOLE USP
Aripiprazole  (USP/EP)
Issue/Submission Date
2014-02-13
2020-03-13
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