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

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01 Amitriptyline Hydrochloride (1)

02 Atorvastatin (2)

03 Baclofen (1)

04 Brivaracetam (1)

05 Clomipramine Hydrochloride (1)

06 Clozapine (1)

07 Elagolix Sodium (1)

08 Etoricoxib (1)

09 Haloperidol (1)

10 Haloperidol Decanoate (1)

11 Lasmiditan (1)

12 Lifitegrast (1)

13 Luliconazole (1)

14 Lumateperone Tosylate (1)

15 Moxifloxacin Hydrochloride (1)

16 Nitrofurantoin (3)

17 Obeticholic Acid (1)

18 Ozanimod (1)

19 Pantoprazole Sodium (2)

20 Pimavanserin Tartrate (1)

21 Propranolol Hydrochloride (1)

22 Ranolazine (1)

23 Revefenacin (1)

24 Rifaximin (1)

25 Rosuvastatin Calcium (1)

26 Sacubitril Sodium (2)

27 Sacubitril-Valsartan (1)

28 Sitagliptin Phosphate (1)

29 Sodium Zirconium Cyclosilicate (1)

30 Sotagliflozin (1)

31 Succinylcholine Chloride (1)

32 Sugammadex Sodium (1)

33 Telmisartan (1)

34 Ticagrelor (1)

35 Upadacitinib (1)

36 Ursodeoxycholic Acid (1)

37 Valsartan (1)

38 Vildagliptin (1)

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01 Active (25)

02 Blank (18)

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01 Valid (11)

02 Blank (32)

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01 Blank (43)

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01 Blank (43)

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USDMF

Found USDMF

33565
Active
AMITRIPTYLINE HYDROCHLORIDE USP
2019-07-24
CEP/COS

Found CEP/COS

R0-CEP 2019-227 - Rev 00
Valid
Amitriptyline hydrochloride
2021-07-16
Japanese DMF

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Written Confirmation

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Application Number
33565
Status
Active
Fees Unpaid
Reviewed
Valid
 
Filing Details
AMITRIPTYLINE HYDROCHLORIDE USP
Amitriptyline hydrochloride
Issue/Submission Date
2019-07-24
2021-07-16
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USDMF

Found USDMF

34844
Active
ATORVASTATIN CALCIUM USP
2020-06-05
CEP/COS

Found CEP/COS

CEP 2022-262 - Rev 00
Valid
Atorvastatin calcium, Trihydrate
2024-02-16
Japanese DMF

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Written Confirmation

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Application Number
34844
Status
Active
Fees Unpaid
Reviewed
Valid
 
Filing Details
ATORVASTATIN CALCIUM USP
Atorvastatin calcium, Trihydrate
Issue/Submission Date
2020-06-05
2024-02-16
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USDMF

Found USDMF

34935
Active
CLOMIPRAMINE HYDROCHLORIDE USP
2020-07-30
CEP/COS

Found CEP/COS

R0-CEP 2020-310 - Rev 00
Valid
Clomipramine Hydrochloride
2022-10-24
Japanese DMF

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Written Confirmation

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Application Number
34935
Status
Active
Fees Unpaid
Reviewed
Valid
 
Filing Details
CLOMIPRAMINE HYDROCHLORIDE USP
Clomipramine Hydrochloride
Issue/Submission Date
2020-07-30
2022-10-24
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USDMF

Found USDMF

34190
Active
HALOPERIDOL USP
2019-11-22
CEP/COS

Found CEP/COS

CEP 2020-026 - Rev 01
Valid
Haloperidol
2024-02-22
Japanese DMF

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Application Number
34190
Status
Active
Fees Unpaid
Reviewed
Valid
 
Filing Details
HALOPERIDOL USP
Haloperidol
Issue/Submission Date
2019-11-22
2024-02-22
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USDMF

Found USDMF

34353
Active
HALOPERIDOL DECANOATE USP
2020-02-26
CEP/COS

Found CEP/COS

R0-CEP 2020-080 - Rev 00
Valid
Haloperidol decanoate
2022-05-20
Japanese DMF

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Written Confirmation

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Application Number
34353
Status
Active
Fees Unpaid
Reviewed
Valid
 
Filing Details
HALOPERIDOL DECANOATE USP
Haloperidol decanoate
Issue/Submission Date
2020-02-26
2022-05-20
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USDMF

Found USDMF

33351
Active
NITROFURANTOIN MONOHYDRATE USP
2018-12-28
CEP/COS

Found CEP/COS

R0-CEP 2021-371 - Rev 00
Valid
Nitrofurantoin, Macrocrystals (Proc...
2021-12-10
Japanese DMF

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Written Confirmation

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Application Number
33351
Status
Active
Fees Unpaid
Reviewed
Valid
 
Filing Details
NITROFURANTOIN MONOHYDRATE USP
Nitrofurantoin, Macrocrystals (Proc...
Issue/Submission Date
2018-12-28
2021-12-10
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USDMF

Found USDMF

33523
Active
NITROFURANTOIN MACROCRYSTALS USP
2019-02-23
CEP/COS

Found CEP/COS

CEP 2019-092 - Rev 02
Valid
Nitrofurantoin, Macrocrystals
2023-10-12
Japanese DMF

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Written Confirmation

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Application Number
33523
Status
Active
Fees Unpaid
Reviewed
Valid
 
Filing Details
NITROFURANTOIN MACROCRYSTALS USP
Nitrofurantoin, Macrocrystals
Issue/Submission Date
2019-02-23
2023-10-12
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USDMF

Found USDMF

35357
Active
PANTOPRAZOLE SODIUM USP
2020-12-07
CEP/COS

Found CEP/COS

R0-CEP 2021-073 - Rev 00
Valid
Pantoprazole sodium sesquihydrate
2022-11-14
Japanese DMF

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Written Confirmation

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Application Number
35357
Status
Active
Fees Unpaid
Reviewed
Valid
 
Filing Details
PANTOPRAZOLE SODIUM USP
Pantoprazole sodium sesquihydrate
Issue/Submission Date
2020-12-07
2022-11-14
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USDMF

Found USDMF

35635
Active
PROPRANOLOL HYDROCHLORIDE USP
2021-03-05
CEP/COS

Found CEP/COS

R0-CEP 2021-104 - Rev 00
Valid
Propranolol hydrochloride
2023-08-30
Japanese DMF

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Written Confirmation

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Application Number
35635
Status
Active
Fees Unpaid
Reviewed
Valid
 
Filing Details
PROPRANOLOL HYDROCHLORIDE USP
Propranolol hydrochloride
Issue/Submission Date
2021-03-05
2023-08-30
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USDMF

Found USDMF

36493
Active
ROSUVASTATIN CALCIUM USP
2021-12-22
CEP/COS

Found CEP/COS

R0-CEP 2022-060 - Rev 00
Valid
Rosuvastatin calcium, Micronised
2023-06-26
Japanese DMF

Close JDMF

Written Confirmation

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Application Number
36493
Status
Active
Fees Unpaid
Reviewed
Valid
 
Filing Details
ROSUVASTATIN CALCIUM USP
Rosuvastatin calcium, Micronised
Issue/Submission Date
2021-12-22
2023-06-26
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