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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Sm Biomed

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01 Azithromycin Dihydrate (1)

02 Beclomethasone Dipropionate (1)

03 Betamethasone Acetate (1)

04 Betamethasone Dipropionate (2)

05 Betamethasone Sodium Phosphate (1)

06 Betamethasone Valerate (1)

07 Budesonide (1)

08 Camylofin Dihydrochloride (1)

09 Cinacalcet Hydrochloride (1)

10 Clarithromycin (2)

11 Clobetasol Propionate (1)

12 Deferasirox (1)

13 Desonide (1)

14 Dexamethasone (2)

15 Dexamethasone Sodium Phosphate (1)

16 Dexamethasone Valerate (1)

17 Diflorasone (1)

18 Erythromycin (2)

19 Erythromycin Estolate (1)

20 Erythromycin Ethyl Succinate (1)

21 Erythromycin Lactobionate (1)

22 Erythromycin Stearate (1)

23 Fluocinolone Acetonide (1)

24 Fluocinonide (1)

25 Glimepiride (1)

26 Halobetasol (1)

27 Latanoprost (1)

28 Lisdexamfetamine Dimesylate (1)

29 Loteprednol Etabonate (1)

30 Metaraminol Bitartrate (1)

31 Prasugrel Hydrochloride (1)

32 Prednisolone Acetate (1)

33 Quetiapine Hemifumarate (1)

34 Saxagliptin (1)

35 Sumatriptan (1)

36 Tapentadol (1)

37 Tramadol Hydrochloride (1)

38 Triamcinolone Acetonide (1)

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01 Active (4)

02 Blank (38)

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01 Valid (7)

02 Blank (35)

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01 Blank (42)

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01 Blank (42)

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USDMF

Found USDMF

24956
Active
ERYTHROMYCIN BASE USP
2011-05-17
CEP/COS

Found CEP/COS

R0-CEP 2020-007 - Rev 00
Valid
Erythromycin, Process 2
2020-05-27
Japanese DMF

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Written Confirmation

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Application Number
24956
Status
Active
Fees Unpaid
Reviewed
Valid
 
Filing Details
ERYTHROMYCIN BASE USP
Erythromycin, Process 2
Issue/Submission Date
2011-05-17
2020-05-27
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USDMF

Found USDMF

32121
Active
ERYTHROMYCIN BASE DIHYDRATE USP
2017-12-05
CEP/COS

Found CEP/COS

R1-CEP 1999-119 - Rev 07
Valid
Erythromycin
2022-10-12
Japanese DMF

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Written Confirmation

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Application Number
32121
Status
Active
Fees Unpaid
Reviewed
Valid
 
Filing Details
ERYTHROMYCIN BASE DIHYDRATE USP
Erythromycin
Issue/Submission Date
2017-12-05
2022-10-12
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USDMF

Found USDMF

31754
Active
ERYTHROMYCIN ETHYLSUCCINATE USP
2017-09-08
CEP/COS

Found CEP/COS

R1-CEP 1999-121 - Rev 04
Valid
Erythromycin ethylsuccinate
2023-03-08
Japanese DMF

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Written Confirmation

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Application Number
31754
Status
Active
Fees Unpaid
Reviewed
Valid
 
Filing Details
ERYTHROMYCIN ETHYLSUCCINATE USP
Erythromycin ethylsuccinate
Issue/Submission Date
2017-09-08
2023-03-08
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USDMF

Found USDMF

32120
Active
ERYTHROMYCIN STEARATE USP
2017-11-16
CEP/COS

Found CEP/COS

R1-CEP 1999-120 - Rev 03
Valid
Erythromycin stearate
2023-03-08
Japanese DMF

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Written Confirmation

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Application Number
32120
Status
Active
Fees Unpaid
Reviewed
Valid
 
Filing Details
ERYTHROMYCIN STEARATE USP
Erythromycin stearate
Issue/Submission Date
2017-11-16
2023-03-08
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USDMF

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CEP/COS

Found CEP/COS

R1-CEP 1999-118 - Rev 00
Valid
Betamethasone valerate
2009-08-12
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Betamethasone valerate
Issue/Submission Date
2009-08-12
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USDMF

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CEP/COS

Found CEP/COS

CEP 2022-483 - Rev 00
Valid
Clarithromycin, Process 2
2023-09-04
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Clarithromycin, Process 2
Issue/Submission Date
2023-09-04
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USDMF

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CEP/COS

Found CEP/COS

R1-CEP 2006-240 - Rev 00
Valid
Clarithromycin
2015-05-12
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Clarithromycin
Issue/Submission Date
2015-05-12
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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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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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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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