01 1Betaxolol
02 1Bimatoprost
03 1Brimonidine Tartrate
04 1Brinzolamide
05 1Bromhexine Hydrochloride
06 1Cinnarizine
07 1Dantrolene Sodium
08 1Diazepam
09 3Dorzolamide Hydrochloride
10 1Econazole Nitrate
11 1Fluconazole
12 2Flunarizine
13 3Flurbiprofen
14 1Flurbiprofen Sodium
15 1Glycopyrronium Bromide
16 1Ketoconazole
17 1Latanoprost
18 1Levalbuterol Hydrochloride
19 1Metaxalone
20 1Metronidazole
21 1Miconazole
22 1Miconazole Nitrate
23 1Nepafenac
24 1Olopatadine Hydrochloride
25 2Rupatadine Fumarate
26 2Salbutamol Sulphate
27 1Telmisartan
28 1Timolol Maleate
29 2Blank
01 13Active
02 12Inactive
03 12Blank
01 16Valid
02 2Withdrawn by Holder
03 19Blank
01 1218MF10559
02 1219MF10187
03 1227MF10140
04 1305MF10115
05 1306MF10124
06 32Blank
01 22WC-0055
02 15Blank
01 120131119-201-I-286-08
02 120210312-209-J-872
03 120210629-209-J-843
04 120210629-209-J-843(2)
05 120210629-209-J-843(A)
06 1Su173-28-ND
07 1Su173-28-ND(1)
08 30Blank
01 155545-0400
02 155545-0405
03 155545-0410
04 155545-0440
05 155545-0452
06 155545-0464
07 155545-0668
08 155545-0702
09 155545-0703
10 155545-0704
11 155545-0705
12 155545-0706
13 25Blank
01 37Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8219
Submission : 1989-09-07
Status : Active
Type : II
Certificate Number : R1-CEP 2003-103 - Rev 03
Issue Date : 2022-10-18
Type : Chemical
Substance Number : 1519
Status : Valid
Registration Number : 219MF10187
Registrant's Address : 142-48,s,v,road,jogeshwari(w),mumbai-400 102 India
Initial Date of Registration : 2007-06-01
Latest Date of Registration :
Date of Issue : 2025-08-08
Valid Till : 2028-07-07
Written Confirmation Number : WC-0055
Address of the Firm :
NDC Package Code : 55545-0405
Start Marketing Date : 1991-01-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Leaders Bio Co., Ltd.
Registration Date : 2021-03-12
Registration Number : 20210312-209-J-872
Manufacturer Name : FDC Limited
Manufacturer Address : Plot No. 19 & 20/2, MIDC, Roha Industrial Area, Village Dhatav, Roha, Raigad 402 116 Maharashtra State, India
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-10-25
Pay. Date : 2012-11-27
DMF Number : 9839
Submission : 1992-07-27
Status : Active
Type : II
Certificate Number : R1-CEP 2003-070 - Rev 03
Issue Date : 2020-09-15
Type : Chemical
Substance Number : 572
Status : Valid
Registration Number : 227MF10140
Registrant's Address : 142-48,s,v,road,jogeshwari(w),mumbai-400 102 India
Initial Date of Registration : 2015-05-14
Latest Date of Registration :
Date of Issue : 2025-08-08
Valid Till : 2028-07-07
Written Confirmation Number : WC-0055
Address of the Firm :
NDC Package Code : 55545-0440
Start Marketing Date : 1983-01-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2013-11-19
Registration Number : 20131119-201-I-286-08
Manufacturer Name : FDC Limited
Manufacturer Address : Plot No. 19 & 20/2, MIDC, Roha Industrial Area, Village Dhatav, Roha-402 116, Dist.- Raigad, Maharashtra State, India.
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20856
Submission : 2007-09-17
Status : Inactive
Type : II
Certificate Number : CEP 2023-236 - Rev 00
Issue Date : 2023-09-07
Type : Chemical
Substance Number : 2359
Status : Valid
Registration Number : 306MF10124
Registrant's Address : 142-48,s,v,road,jogeshwari(w),mumbai-400 102 India
Initial Date of Registration : 2024-09-11
Latest Date of Registration :
Date of Issue : 2025-08-08
Valid Till : 2028-07-07
Written Confirmation Number : WC-0055
Address of the Firm :
NDC Package Code : 55545-0703
Start Marketing Date : 2018-12-11
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Medipoem Co., Ltd.
Registration Date : 2024-10-25
Registration Number : 20210629-209-J-843(2)
Manufacturer Name : FDC Limited
Manufacturer Address : Plot No. 19 & 20/2, MIDC, Roha Industrial Area, Village Dhatav, Roha, Raigad 402116, Maharashtra State, India
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2025-09-16
Pay. Date : 2025-08-18
DMF Number : 20855
Submission : 2007-09-17
Status : Active
Type : II
Certificate Number : CEP 2020-123 - Rev 01
Issue Date : 2026-02-23
Type : Chemical
Substance Number : 2760
Status : Valid
Date of Issue : 2025-08-08
Valid Till : 2028-07-07
Written Confirmation Number : WC-0055
Address of the Firm :
NDC Package Code : 55545-0668
Start Marketing Date : 2002-01-01
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
Certificate Number : R1-CEP 2007-032 - Rev 03
Issue Date : 2023-01-23
Type : Chemical
Substance Number : 706
Status : Valid
Registration Number : 305MF10115
Registrant's Address : 142-48,s,v,road,jogeshwari(w),mumbai-400 102 India
Initial Date of Registration : 2023-10-12
Latest Date of Registration :
Date of Issue : 2025-08-08
Valid Till : 2028-07-07
Written Confirmation Number : WC-0055
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31934
Submission : 2017-09-07
Status : Active
Type : II
Certificate Number : CEP 2003-150 - Rev 04
Issue Date : 2025-04-07
Type : Chemical
Substance Number : 816
Status : Valid
Date of Issue : 2025-08-08
Valid Till : 2028-07-07
Written Confirmation Number : WC-0055
Address of the Firm :
NDC Package Code : 55545-0702
Start Marketing Date : 2017-12-20
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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 10456
Submission : 1993-08-09
Status : Active
Type : II
Certificate Number : CEP 2003-133 - Rev 02
Issue Date : 2024-07-08
Type : Chemical
Substance Number : 665
Status : Valid
Date of Issue : 2025-08-08
Valid Till : 2028-07-07
Written Confirmation Number : WC-0055
Address of the Firm :
NDC Package Code : 55545-0452
Start Marketing Date : 2003-01-01
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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 23813
Submission : 2010-05-18
Status : Active
Type : II
Certificate Number : CEP 2024-162 - Rev 01
Issue Date : 2025-10-27
Type : Chemical
Substance Number : 2230
Status : Valid
Date of Issue : 2025-08-08
Valid Till : 2028-07-07
Written Confirmation Number : WC-0055
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-03-31
Pay. Date : 2023-03-29
DMF Number : 7376
Submission : 1988-03-04
Status : Active
Type : II
Certificate Number : CEP 1998-146 - Rev 04
Issue Date : 2024-08-19
Type : Chemical
Substance Number : 513
Status : Valid
Date of Issue : 2025-08-08
Valid Till : 2028-07-07
Written Confirmation Number : WC-0055
Address of the Firm :
NDC Package Code : 55545-0400
Start Marketing Date : 1985-01-01
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 : 2014-06-05
Pay. Date : 2014-05-28
DMF Number : 7809
Submission : 1988-12-12
Status : Active
Type : II
Certificate Number : CEP 2015-212 - Rev 02
Issue Date : 2024-06-12
Type : Chemical
Substance Number : 687
Status : Valid
Date of Issue : 2025-08-08
Valid Till : 2028-07-07
Written Confirmation Number : WC-0055
Address of the Firm :
NDC Package Code : 55545-0410
Start Marketing Date : 1994-01-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
FDC is a supplier offers 36 products (APIs, Excipients or Intermediates).
Find Flurbiprofen bulk with DMF, CEP, JDMF, WC offered by FDC
Find Timolol Maleate bulk with DMF, CEP, JDMF, WC offered by FDC
Find Dorzolamide Hydrochloride bulk with CEP, JDMF, WC offered by FDC
Find Brimonidine Tartrate bulk with DMF, CEP, WC offered by FDC
Find Bromhexine Hydrochloride bulk with CEP, JDMF, WC offered by FDC
Find Cinnarizine bulk with DMF, CEP, WC offered by FDC
Find Econazole Nitrate bulk with DMF, CEP, WC offered by FDC
Find Latanoprost bulk with DMF, CEP, WC offered by FDC
Find Miconazole Nitrate bulk with DMF, CEP, WC offered by FDC
Find Salbutamol Sulphate bulk with DMF, CEP, WC offered by FDC
Find Fluconazole bulk with CEP, WC offered by FDC
Find Miconazole bulk with CEP, WC offered by FDC
Find Betaxolol bulk with CEP, WC offered by FDC
Find Bimatoprost bulk with DMF, WC offered by FDC
Find Brinzolamide bulk with DMF, WC offered by FDC
Find Flurbiprofen bulk with CEP, JDMF offered by FDC
Find Nepafenac bulk with DMF, WC offered by FDC
Find Olopatadine Hydrochloride bulk with DMF, WC offered by FDC
Find Rupatadine Fumarate bulk with CEP, WC offered by FDC
Find Dorzolamide Hydrochloride bulk with DMF offered by FDC
Find Flunarizine bulk with WC offered by FDC
Find Flurbiprofen Sodium bulk with WC offered by FDC
Find Glycopyrronium Bromide bulk with CEP offered by FDC
Find Salbutamol Sulphate bulk with WC offered by FDC
Find Dantrolene Sodium bulk offered by FDC
Find Diazepam bulk offered by FDC
Find Flurbiprofen bulk offered by FDC
Find Ketoconazole bulk offered by FDC
Find Levalbuterol Hydrochloride bulk offered by FDC
Find Metaxalone bulk offered by FDC
Find Metronidazole bulk offered by FDC
Find Telmisartan bulk offered by FDC
Find MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MAHARASHTRA STATE, INDIA. bulk offered by FDC
Find FACILS & GEN. OPERATING PROCEDS. FOR MFGR OF BULK DRUG PRODS: W/FORMU bulk offered by FDC
Find Dorzolamide Hydrochloride bulk offered by FDC
Find Rupatadine Fumarate bulk offered by FDC
