Company profile for FDC

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About

FDC continues to uphold the pioneering spirit of its founding vision, achieving accreditations from esteemed regulatory bodies such as the US-FDA, UK-MHRA, MCC-RSA, and UAE authorities, among others. As a leader in the production of ORS and ophthalmic products, FDC has established globally approved manufacturing facilities for Active Pharmaceutical Ingredients (APIs) and Finished Dosage Forms across multiple locations. These f...
FDC continues to uphold the pioneering spirit of its founding vision, achieving accreditations from esteemed regulatory bodies such as the US-FDA, UK-MHRA, MCC-RSA, and UAE authorities, among others. As a leader in the production of ORS and ophthalmic products, FDC has established globally approved manufacturing facilities for Active Pharmaceutical Ingredients (APIs) and Finished Dosage Forms across multiple locations. These facilities are situated in Roha, Waluj, and Sinnar in Maharashtra, Verna in Goa, and Baddi in Himachal Pradesh. With a diverse portfolio of over 300 products, FDC exports its offerings to more than 50 countries worldwide.

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CONTACT DETAILS

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Country
Country
India
Address
Address
B - 8 MIDC area, Waluj - 431 136 District - Aurangabad, Maharashtra
Telephone
Telephone
youtube
YouTube
Twitter
Twitter

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Events

Webinars & Exhibitions

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NEWS #PharmaBuzz

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

FDA
02 Oct 2025

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

FDA
04 Aug 2025

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

FDA
14 Jul 2025

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

FDA
14 May 2025

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

ECONOMICTIMES
09 May 2025

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-march-26-2025-60230.pdf

FDA
26 Mar 2025

01

Flurbiprofen

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

BIO Partnering at JPM
Not Confirmed
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Flurbiprofen

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

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BIO Partnering at JPM
Not Confirmed
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02

Timolol Maleate

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

BIO Partnering at JPM
Not Confirmed
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Timolol Maleate

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

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BIO Partnering at JPM
Not Confirmed
USDMF arrow-down CEP/COS arrow-down JDMF arrow-down EU-WCarrow-down NDC arrow-down KDMF arrow-down VMF Others AUDIT
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03

Dorzolamide Hydrochloride

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

BIO Partnering at JPM
Not Confirmed
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Dorzolamide Hydrochloride

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

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BIO Partnering at JPM
Not Confirmed
USDMF Inactive-api CEP/COS arrow-down JDMF arrow-down EU-WCarrow-down NDC arrow-down KDMF arrow-down VMF Others AUDIT
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04

Brimonidine Tartrate

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

BIO Partnering at JPM
Not Confirmed
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Brimonidine Tartrate

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

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BIO Partnering at JPM
Not Confirmed
USDMF arrow-down CEP/COS arrow-down JDMF EU-WCarrow-down NDC arrow-down KDMF VMF Others AUDIT
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05

Bromhexine Hydrochloride

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

BIO Partnering at JPM
Not Confirmed
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Bromhexine Hydrochloride

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

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BIO Partnering at JPM
Not Confirmed
USDMF CEP/COS arrow-down JDMF arrow-down EU-WCarrow-down NDC KDMF VMF Others AUDIT
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06

Cinnarizine

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

BIO Partnering at JPM
Not Confirmed
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Cinnarizine

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

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BIO Partnering at JPM
Not Confirmed
USDMF arrow-down CEP/COS arrow-down JDMF EU-WCarrow-down NDC arrow-down KDMF VMF Others AUDIT
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07

Econazole Nitrate

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

BIO Partnering at JPM
Not Confirmed
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Econazole Nitrate

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

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BIO Partnering at JPM
Not Confirmed
USDMF arrow-down CEP/COS arrow-down JDMF EU-WCarrow-down NDC arrow-down KDMF VMF Others AUDIT
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08

Latanoprost

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

BIO Partnering at JPM
Not Confirmed
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Latanoprost

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

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BIO Partnering at JPM
Not Confirmed
USDMF arrow-down CEP/COS arrow-down JDMF EU-WCarrow-down NDC KDMF VMF Others AUDIT
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09

Miconazole Nitrate

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

BIO Partnering at JPM
Not Confirmed
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Miconazole Nitrate

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

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BIO Partnering at JPM
Not Confirmed
USDMF arrow-down CEP/COS arrow-down JDMF EU-WCarrow-down NDC arrow-down KDMF VMF Others AUDIT
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10

Salbutamol Sulphate

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

BIO Partnering at JPM
Not Confirmed
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Salbutamol Sulphate

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

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BIO Partnering at JPM
Not Confirmed
USDMF arrow-down CEP/COS arrow-down JDMF EU-WCarrow-down NDC arrow-down KDMF VMF Others AUDIT
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USDMF

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01

BIO Partnering at JPM
Not Confirmed
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BIO Partnering at JPM
Not Confirmed

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

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02

BIO Partnering at JPM
Not Confirmed
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03

BIO Partnering at JPM
Not Confirmed
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BIO Partnering at JPM
Not Confirmed

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

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04

BIO Partnering at JPM
Not Confirmed
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05

BIO Partnering at JPM
Not Confirmed
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06

BIO Partnering at JPM
Not Confirmed
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07

BIO Partnering at JPM
Not Confirmed
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09

BIO Partnering at JPM
Not Confirmed
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10

BIO Partnering at JPM
Not Confirmed
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Drugs in Development

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  • Development Update

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

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01

FDC

India
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BIO Partnering at JPM
Not Confirmed

FDC

India
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BIO Partnering at JPM
Not Confirmed

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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Inspections and registrations

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ABOUT THIS PAGE

Contact FDC and get a quotation

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

Find a price of Timolol Maleate bulk with DMF, CEP, JDMF, WC offered by FDC

Find a price of Dorzolamide Hydrochloride bulk with CEP, JDMF, WC offered by FDC

Find a price of Brimonidine Tartrate bulk with DMF, CEP, WC offered by FDC

Find a price of Bromhexine Hydrochloride bulk with CEP, JDMF, WC offered by FDC

Find a price of Cinnarizine bulk with DMF, CEP, WC offered by FDC

Find a price of Econazole Nitrate bulk with DMF, CEP, WC offered by FDC

Find a price of Latanoprost bulk with DMF, CEP, WC offered by FDC

Find a price of Miconazole Nitrate bulk with DMF, CEP, WC offered by FDC

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

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