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24-26 February, 2026
BIO Partnering at JPMBIO Partnering at JPM
Industry Trade Show
Not Confirmed
12-15 January, 2026
Biotech ShowcaseBiotech Showcase
Industry Trade Show
Not Confirmed
12-14 January, 2026
Digital content

02 Oct 2025
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217052

04 Aug 2025
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219475

14 Jul 2025
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217051

14 May 2025
// FDA
https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-may-14-2025-10495.pdf

09 May 2025
// ECONOMICTIMES
https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/fdc-recalls-over-60000-bottles-of-ophthalmic-solution-in-us/articleshow/121030785.cms

26 Mar 2025
// FDA
https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-march-26-2025-60230.pdf
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8219
Submission : 1989-09-07
Status : Active
Type : II
Certificate Number : CEP 2025-225 - Rev 00
Issue Date : 2025-08-13
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 : R1-CEP 2014-288 - Rev 00
Issue Date : 2021-03-02
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 : R0-CEP 2020-123 - Rev 00
Issue Date : 2022-06-13
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

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GDUFA
DMF Review : Complete
Rev. Date : 2014-06-05
Pay. Date : 2014-05-28
DMF Number : 7809
Submission : 1988-12-12
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40350
Submission : 2024-08-12
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2025-09-16
Pay. Date : 2025-08-18
DMF Number : 20855
Submission : 2007-09-17
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39512
Submission : 2024-03-06
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31934
Submission : 2017-09-07
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17446
Submission : 2004-05-27
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7025
Submission : 1987-06-18
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20856
Submission : 2007-09-17
Status : Inactive
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2019-08-26
Pay. Date : 2019-06-21
DMF Number : 33576
Submission : 2019-04-02
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10456
Submission : 1993-08-09
Status : Active
Type : II

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Details:
PiFLU (favipiravir), is an oral broad-spectrum inhibitor of viral RNA-dependent RNA polymerase, which is indicated for the treatment of COVID-19 infection.
Lead Product(s): Favipiravir
Therapeutic Area: Infections and Infectious Diseases Brand Name: PiFlu
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 26, 2020

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Lead Product(s) : Favipiravir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
FDC Launches Two Variants of COVID-19 Drug Favipiravir in India at ₹55 Per Tablet
Details : PiFLU (favipiravir), is an oral broad-spectrum inhibitor of viral RNA-dependent RNA polymerase, which is indicated for the treatment of COVID-19 infection.
Product Name : PiFlu
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 26, 2020

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FDC is a supplier offers 36 products (APIs, Excipients or Intermediates).
Find a price of Flurbiprofen bulk with DMF, CEP, JDMF, WC offered by FDC
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Find a price of Latanoprost bulk with DMF, CEP, WC offered by FDC
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Find a price of Salbutamol Sulphate bulk with DMF, CEP, WC offered by FDC
Find a price of Fluconazole bulk with CEP, WC offered by FDC
Find a price of Miconazole bulk with CEP, WC offered by FDC
Find a price of Betaxolol bulk with CEP, WC offered by FDC
Find a price of Bimatoprost bulk with DMF, WC offered by FDC
Find a price of Brinzolamide bulk with DMF, WC offered by FDC
Find a price of Dorzolamide Hydrochloride bulk with DMF, CEP offered by FDC
Find a price of Flurbiprofen bulk with CEP, JDMF offered by FDC
Find a price of Nepafenac bulk with DMF, WC offered by FDC
Find a price of Olopatadine Hydrochloride bulk with DMF, WC offered by FDC
Find a price of Rupatadine Fumarate bulk with CEP, WC offered by FDC
Find a price of Flunarizine bulk with WC offered by FDC
Find a price of Flurbiprofen bulk with CEP offered by FDC
Find a price of Flurbiprofen Sodium bulk with WC offered by FDC
Find a price of Glycopyrronium Bromide bulk with CEP offered by FDC
Find a price of Salbutamol Sulphate bulk with WC offered by FDC
Find a price of Dantrolene bulk offered by FDC
Find a price of Diazepam bulk offered by FDC
Find a price of Ketoconazole bulk offered by FDC
Find a price of Levalbuterol Hydrochloride bulk offered by FDC
Find a price of Metaxalone bulk offered by FDC
Find a price of Metronidazole bulk offered by FDC
Find a price of Telmisartan bulk offered by FDC
Find a price of MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MAHARASHTRA STATE, INDIA. bulk offered by FDC
Find a price of FACILS & GEN. OPERATING PROCEDS. FOR GR OF BULK DRUG PRODS: W/FORMU bulk offered by FDC
Find a price of Dorzolamide Hydrochloride bulk offered by FDC
Find a price of Rupatadine Fumarate bulk offered by FDC