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01 1Azithromycin Dihydrate
02 1Beclomethasone Dipropionate
03 1Betamethasone Acetate
04 2Betamethasone Dipropionate
05 1Betamethasone Sodium Phosphate
06 1Betamethasone Valerate
07 1Budesonide
08 1Camylofin Dihydrochloride
09 1Cinacalcet Hydrochloride
10 2Clarithromycin
11 1Clobetasol Propionate
12 1Deferasirox
13 1Desonide
14 3Dexamethasone
15 1Dexamethasone Sodium Phosphate
16 1Diflorasone
17 2Erythromycin
18 1Erythromycin Estolate
19 1Erythromycin Ethyl Succinate
20 1Erythromycin Lactobionate
21 1Erythromycin Stearate
22 1Fluocinolone Acetonide
23 1Fluocinonide
24 1Glimepiride
25 1Halobetasol
26 1Latanoprost
27 1Lisdexamfetamine Dimesylate
28 1Loteprednol Etabonate
29 1Metaraminol Bitartrate
30 1Prasugrel Hydrochloride
31 1Prednisolone Acetate
32 1Quetiapine Hemifumarate
33 1Saxagliptin
34 1Sumatriptan
35 1Tapentadol
36 1Tramadol Hydrochloride
37 1Triamcinolone Acetonide
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01 4Active
02 38Blank
01 8Withdrawn by EDQM GMP non-compliance
02 34Blank
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01 42Blank
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01 120120601-107-F-64-02(1)
02 41Blank
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01 152334-001
02 152334-002
03 152334-003
04 152334-004
05 38Blank
01 42Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-10-03
Pay. Date : 2017-09-28
DMF Number : 24956
Submission : 2011-05-17
Status : Active
Type : II
Certificate Number : CEP 2020-007 - Rev 01
Issue Date : 2025-03-14
Type : Chemical
Substance Number : 179
Status : Withdrawn by EDQM G...
NDC Package Code : 52334-004
Start Marketing Date : 2016-11-21
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Hiple Co., Ltd.
Registration Date : 2015-11-17
Registration Number : 20120601-107-F-64-02(1)
Manufacturer Name : SM Biomed SDN.BHD.
Manufacturer Address : Lot 90, Sungai Petani Industrial Estate, 08000 Sungai Petani, Kedah, Malaysia (Erythromycin Thiocyanate Manufacturing Plant: HEC Pharm co.ltd, No62, Binjiang Road, Yidu City, Hubei Province, China)

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-01-19
Pay. Date : 2017-11-30
DMF Number : 32121
Submission : 2017-12-05
Status : Active
Type : II
Certificate Number : R1-CEP 1999-119 - Rev 07
Issue Date : 2022-10-12
Type : Chemical
Substance Number : 179
Status : Withdrawn by EDQM G...
NDC Package Code : 52334-001
Start Marketing Date : 2008-02-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-09-21
Pay. Date : 2017-08-10
DMF Number : 31754
Submission : 2017-09-08
Status : Active
Type : II
Certificate Number : R1-CEP 1999-121 - Rev 04
Issue Date : 2023-03-08
Type : Chemical
Substance Number : 274
Status : Withdrawn by EDQM G...
NDC Package Code : 52334-003
Start Marketing Date : 2016-04-07
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-01-03
Pay. Date : 2017-10-24
DMF Number : 32120
Submission : 2017-11-16
Status : Active
Type : II
Certificate Number : R1-CEP 1999-120 - Rev 03
Issue Date : 2023-03-08
Type : Chemical
Substance Number : 490
Status : Withdrawn by EDQM G...
NDC Package Code : 52334-002
Start Marketing Date : 2016-04-07
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 1999-118 - Rev 00
Issue Date : 2009-08-12
Type : Chemical
Substance Number : 811
Status : Withdrawn by EDQM G...

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2022-483 - Rev 00
Issue Date : 2023-09-04
Type : Chemical
Substance Number : 1651
Status : Withdrawn by EDQM G...

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2006-240 - Rev 00
Issue Date : 2015-05-12
Type : Chemical
Substance Number : 1651
Status : Withdrawn by EDQM G...

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2024-065 - Rev 00
Issue Date : 2025-01-03
Type : Chemical and TSE
Substance Number : 549
Status : Withdrawn by EDQM G...

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Sm Biomed is a supplier offers 37 products (APIs, Excipients or Intermediates).
Find Erythromycin bulk with DMF offered by Sm Biomed
Find Erythromycin Ethyl Succinate bulk with DMF offered by Sm Biomed
Find Erythromycin Stearate bulk with DMF offered by Sm Biomed
Find Betamethasone Valerate bulk offered by Sm Biomed
Find Clarithromycin bulk offered by Sm Biomed
Find Dexamethasone Sodium Phosphate bulk offered by Sm Biomed
Find Azithromycin Dihydrate bulk offered by Sm Biomed
Find Beclomethasone Dipropionate bulk offered by Sm Biomed
Find Betamethasone Acetate bulk offered by Sm Biomed
Find Betamethasone Dipropionate bulk offered by Sm Biomed
Find Betamethasone Sodium Phosphate bulk offered by Sm Biomed
Find Budesonide bulk offered by Sm Biomed
Find Camylofin Dihydrochloride bulk offered by Sm Biomed
Find Cinacalcet Hydrochloride bulk offered by Sm Biomed
Find Clobetasol Propionate bulk offered by Sm Biomed
Find Deferasirox bulk offered by Sm Biomed
Find Desonide bulk offered by Sm Biomed
Find Dexamethasone bulk offered by Sm Biomed
Find Diflorasone bulk offered by Sm Biomed
Find Erythromycin Estolate bulk offered by Sm Biomed
Find Erythromycin Lactobionate bulk offered by Sm Biomed
Find Fluocinolone Acetonide bulk offered by Sm Biomed
Find Fluocinonide bulk offered by Sm Biomed
Find Glimepiride bulk offered by Sm Biomed
Find Halobetasol bulk offered by Sm Biomed
Find Latanoprost bulk offered by Sm Biomed
Find Lisdexamfetamine Dimesylate bulk offered by Sm Biomed
Find Loteprednol Etabonate bulk offered by Sm Biomed
Find Metaraminol Bitartrate bulk offered by Sm Biomed
Find Prasugrel Hydrochloride bulk offered by Sm Biomed
Find Prednisolone Acetate bulk offered by Sm Biomed
Find Quetiapine Hemifumarate bulk offered by Sm Biomed
Find Saxagliptin bulk offered by Sm Biomed
Find Sumatriptan bulk offered by Sm Biomed
Find Tapentadol bulk offered by Sm Biomed
Find Tramadol Hydrochloride bulk offered by Sm Biomed
Find Triamcinolone Acetonide bulk offered by Sm Biomed