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Athena Athena

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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Indoco Remedies Limited

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01 Allopurinol (1)

02 Alogliptin Benzoate (1)

03 Amiodarone Hydrochloride (1)

04 Apixaban (1)

05 Aripiprazole (1)

06 Besifloxacin Hydrochloride (1)

07 Betaxolol (1)

08 Brimonidine Tartrate (1)

09 Brinzolamide (1)

10 Bromfenac Sodium (1)

11 Canagliflozin (1)

12 Cetirizine Dihydrochloride (1)

13 Chlorzoxazone (1)

14 Ciprofloxacin Hydrochloride (1)

15 Dapagliflozin (1)

16 Dicyclomine (1)

17 Dicyclomine Hydrochloride (1)

18 Domperidone (1)

19 Domperidone Maleate (1)

20 Dorzolamide Hydrochloride (2)

21 Febuxostat (1)

22 Gliclazide (1)

23 Glimepiride (1)

24 Lacosamide (2)

25 Metformin (1)

26 Metoprolol Succinate (1)

27 Mirabegron (1)

28 Moxifloxacin Hydrochloride (1)

29 Neostigmine Methylsulfate (1)

30 Netarsudil (1)

31 Olopatadine Hydrochloride (1)

32 Phenylephrine Hydrochloride (1)

33 Posaconazole (1)

34 Pregabalin (1)

35 Quetiapine Hemifumarate (1)

36 Rasagiline Mesylate (1)

37 Rasagiline Tartrate (1)

38 Rivaroxaban (1)

39 Rufinamide (1)

40 Sitagliptin Phosphate (1)

41 Vildagliptin (1)

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01 Active (21)

02 Inactive (3)

03 Blank (19)

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01 Valid (12)

02 Withdrawn by Holder (2)

03 Blank (29)

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01 225MF10144 (1)

02 226MF10115 (1)

03 Blank (41)

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01 WC-0151 (11)

02 WC-0152 (10)

03 Blank (22)

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USDMF

Found USDMF

21239
Active
ALLOPURINOL USP
2008-01-15
CEP/COS

Found CEP/COS

CEP 2008-017 - Rev 04
Valid
Allopurinol
2023-11-20
Japanese DMF

Found JDMF

225MF10144
Allopurinol at 'Indoco House', 166 ...
2013-07-25
Written Confirmation

Caution WC

Indian CDSCO WC-0151
Expired
Allopurinol (Ph. Eur./BP/USP)
2019-08-16
Application Number
21239
225MF10144
Indian CDSCO WC-0151
Status
Active
Fees Paid
N/A
Valid
 
Expired
2022-08-15
Filing Details
ALLOPURINOL USP
Allopurinol
Allopurinol at 'Indoco House', 166 ...
Allopurinol (Ph. Eur./BP/USP)
Issue/Submission Date
2008-01-15
2023-11-20
2013-07-25
2019-08-16
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USDMF

Found USDMF

22295
Active
DICYCLOMINE HYDROCHLORIDE USP
2008-12-04
CEP/COS

Found CEP/COS

CEP 2008-281 - Rev 06
Valid
Dicycloverine Hydrochloride
2024-01-17
Japanese DMF

Found JDMF

226MF10115
Dicyclomine hydrochloride at 'Indoc...
2014-06-18
Written Confirmation

Caution WC

Indian CDSCO WC-0151
Expired
Dicycloverine HCl (Ph. Eur./BP)/Dic...
2019-08-16
Application Number
22295
226MF10115
Indian CDSCO WC-0151
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-08-15
Filing Details
DICYCLOMINE HYDROCHLORIDE USP
Dicycloverine Hydrochloride
Dicyclomine hydrochloride at 'Indoc...
Dicycloverine HCl (Ph. Eur./BP)/Dic...
Issue/Submission Date
2008-12-04
2024-01-17
2014-06-18
2019-08-16
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USDMF

Found USDMF

25301
Active
BETAXOLOL HYDROCHLORIDE USP
2011-09-22
CEP/COS

Found CEP/COS

R1-CEP 2011-031 - Rev 01
Valid
Betaxolol hydrochloride
2020-04-07
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0151
Expired
Betaxolol HCl (Ph. Eur./BP/USP)
2019-08-16
Application Number
25301
Indian CDSCO WC-0151
Status
Active
Fees Paid
N/A
Valid
 
Expired
2022-08-15
Filing Details
BETAXOLOL HYDROCHLORIDE USP
Betaxolol hydrochloride
Betaxolol HCl (Ph. Eur./BP/USP)
Issue/Submission Date
2011-09-22
2020-04-07
2019-08-16
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USDMF

Found USDMF

22166
Active
BRIMONIDINE TARTRATE USP
2008-10-29
CEP/COS

Found CEP/COS

R1-CEP 2014-180 - Rev 00
Valid
Brimonidine tartrate
2020-03-03
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0152
Expired
Brimonidine Tartarate (IH)
2019-07-15
Application Number
22166
Indian CDSCO WC-0152
Status
Active
Fees Paid
N/A
Valid
 
Expired
2022-07-15
Filing Details
BRIMONIDINE TARTRATE USP
Brimonidine tartrate
Brimonidine Tartarate (IH)
Issue/Submission Date
2008-10-29
2020-03-03
2019-07-15
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USDMF

Found USDMF

23795
Active
DORZOLAMIDE HYDROCHLORIDE USP
2010-05-05
CEP/COS

Found CEP/COS

CEP 2011-015 - Rev 01
Valid
Dorzolamide hydrochloride
2023-12-12
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0151
Expired
Dorzolamide HCl (Ph. Eur./BP/USP)
2019-08-16
Application Number
23795
Indian CDSCO WC-0151
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-08-15
Filing Details
DORZOLAMIDE HYDROCHLORIDE USP
Dorzolamide hydrochloride
Dorzolamide HCl (Ph. Eur./BP/USP)
Issue/Submission Date
2010-05-05
2023-12-12
2019-08-16
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USDMF

Found USDMF

22565
Active
GLIMEPIRIDE USP
2009-01-12
CEP/COS

Found CEP/COS

CEP 2009-067 - Rev 04
Valid
Glimepiride
2024-02-05
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0151
Expired
Glimepiride (Ph. Eur./BP/USP)
2019-08-16
Application Number
22565
Indian CDSCO WC-0151
Status
Active
Fees Paid
N/A
Valid
 
Expired
2022-08-15
Filing Details
GLIMEPIRIDE USP
Glimepiride
Glimepiride (Ph. Eur./BP/USP)
Issue/Submission Date
2009-01-12
2024-02-05
2019-08-16
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USDMF

Found USDMF

29476
Active
LACOSAMIDE USP
2015-07-10
CEP/COS

Found CEP/COS

CEP 2021-147 - Rev 02
Valid
Lacosamide, Process II
2024-02-22
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0152
Expired
Lacosamide IH/EP
2019-07-15
Application Number
29476
Indian CDSCO WC-0152
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-07-15
Filing Details
LACOSAMIDE USP
Lacosamide, Process II
Lacosamide IH/EP
Issue/Submission Date
2015-07-10
2024-02-22
2019-07-15
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USDMF

Caution USDMF

25000
Inactive
QUETIAPINE FUMARATE
2011-10-14
CEP/COS

Found CEP/COS

R1-CEP 2014-279 - Rev 01
Valid
Quetiapine Fumarate
2022-10-17
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0151
Expired
Quetiapine Fumarate (IH)
2019-08-16
Application Number
25000
Indian CDSCO WC-0151
Status
Inactive
Fees Paid
N/A
Valid
 
Expired
2022-08-15
Filing Details
QUETIAPINE FUMARATE
Quetiapine Fumarate
Quetiapine Fumarate (IH)
Issue/Submission Date
2011-10-14
2022-10-17
2019-08-16
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USDMF

Found USDMF

37570
Active
RIVAROXABAN USP
2022-11-10
CEP/COS

Found CEP/COS

R0-CEP 2022-159 - Rev 00
Valid
Rivaroxaban, Micronised
2023-06-26
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
37570
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
RIVAROXABAN USP
Rivaroxaban, Micronised
Issue/Submission Date
2022-11-10
2023-06-26
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USDMF

Found USDMF

30612
Active
ALOGLIPTIN BENZOATE
2016-06-30
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0151
Expired
Alogliptin Benzoate IH
2019-08-16
Application Number
30612
Indian CDSCO WC-0151
Status
Active
Fees Paid
Reviewed
 
Expired
2022-08-15
Filing Details
ALOGLIPTIN BENZOATE
Alogliptin Benzoate IH
Issue/Submission Date
2016-06-30
2019-08-16
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