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Digital content

21 Aug 2025
// PRESS RELEASE
https://www.expresspharma.in/extrovis-ag-and-dr-reddys-launch-authorised-generic-fluorouracil-cream-0-5-per-cent-in-us-market/

16 Jun 2023
// EMA
https://www.ema.europa.eu/en/documents/overview/sugammadex-adroiq-epar-medicine-overview_en.pdf

05 Jun 2023
// EMA
https://www.ema.europa.eu/en/documents/overview/lacosamide-adroiq-epar-medicine-overview_en.pdf

19 Jan 2023
// MARKET SCREENER
https://www.marketscreener.com/quote/stock/MEGASOFT-LIMITED-6498580/news/Megasoft-Limited-completed-the-acquisition-of-40-stake-in-Extrovis-AG-42781952/

15 May 2022
// MARKETSCREENER
https://www.marketscreener.com/quote/stock/MEGASOFT-LIMITED-6498580/news/Megasoft-Limited-agreed-to-acquire-40-stake-in-EXTROVIS-AG-for-16-million-40454341/
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33630
Submission : 2019-03-09
Status : Active
Type : II
Certificate Number : CEP 2022-379 - Rev 00
Issue Date : 2024-06-12
Type : Chemical
Substance Number : 77
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42902
Submission : 2025-12-30
Status : Active
Type : II

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-10-24
Pay. Date : 2023-10-03
DMF Number : 37213
Submission : 2023-07-05
Status : Active
Type : II

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37907
Submission : 2023-03-29
Status : Active
Type : II

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2025-03-28
Pay. Date : 2025-03-07
DMF Number : 38689
Submission : 2023-08-08
Status : Active
Type : II

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2025-04-04
Pay. Date : 2025-03-07
DMF Number : 38688
Submission : 2023-08-04
Status : Active
Type : II

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34316
Submission : 2020-01-22
Status : Active
Type : II

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39511
Submission : 2024-02-09
Status : Active
Type : II

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35193
Submission : 2020-12-22
Status : Inactive
Type : II

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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42902
Submission : 2025-12-30
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2023-10-24
Pay. Date : 2023-10-03
DMF Number : 37213
Submission : 2023-07-05
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33630
Submission : 2019-03-09
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2025-04-04
Pay. Date : 2025-03-07
DMF Number : 38688
Submission : 2023-08-04
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37907
Submission : 2023-03-29
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2025-03-28
Pay. Date : 2025-03-07
DMF Number : 38689
Submission : 2023-08-08
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35193
Submission : 2020-12-22
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34316
Submission : 2020-01-22
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39511
Submission : 2024-02-09
Status : Active
Type : II

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Details:
Fluorouracil inhibits fungal DNA and RNA synthesis, is indicated for the topical treatment of multiple actinic or solar keratoses of the face and anterior scalp.
Lead Product(s): Fluorouracil
Therapeutic Area: Dermatology Brand Name: Carac-Generic
Study Phase: Approved FDFProduct Type: Cytotoxic Drug
Sponsor: Dr. Reddy\'s Laboratories
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 20, 2025

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Lead Product(s) : Fluorouracil
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Dr. Reddy\'s Laboratories
Deal Size : Inapplicable
Deal Type : Inapplicable
Extrovis, Dr Reddy’s Launch Generic Fluorouracil Cream 0.5% In U.S.
Details : Fluorouracil inhibits fungal DNA and RNA synthesis, is indicated for the topical treatment of multiple actinic or solar keratoses of the face and anterior scalp.
Product Name : Carac-Generic
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
August 20, 2025

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Regulatory Info : DISCN
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : AZITHROMYCIN
Dosage Strength : EQ 500MG BASE
Packaging :
Approval Date : 2007-05-30
Application Number : 65366
Regulatory Info : DISCN
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Dosage Form : INJECTABLE;INJECTION
Brand Name : CALCIUM CHLORIDE 10%
Dosage Strength : 100MG/ML
Packaging :
Approval Date : 2024-11-27
Application Number : 219342
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : DISCN
Registration Country : USA
CLINDAMYCIN PALMITATE HYDROCHLORIDE
Dosage Form : FOR SOLUTION;ORAL
Brand Name : CLINDAMYCIN PALMITATE HYD...
Dosage Strength : EQ 75MG BASE/5ML
Packaging :
Approval Date : 2016-05-25
Application Number : 203063
Regulatory Info : DISCN
Registration Country : USA

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Regulatory Info : DISCN
Registration Country : USA
Dosage Form : INJECTABLE;INJECTION
Brand Name : FLUDARABINE PHOSPHATE
Dosage Strength : 50MG/2ML (25MG/ML)
Packaging :
Approval Date : 2011-12-21
Application Number : 200647
Regulatory Info : DISCN
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Dosage Form : SOLUTION;TOPICAL
Brand Name : EFUDEX
Dosage Strength : 2%
Packaging :
Approval Date : 1982-01-01
Application Number : 16831
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : DISCN
Registration Country : USA
Dosage Form : SOLUTION;TOPICAL
Brand Name : EFUDEX
Dosage Strength : 5% **Federal Register ...
Packaging :
Approval Date : 1982-01-01
Application Number : 16831
Regulatory Info : DISCN
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Dosage Form : CREAM;TOPICAL
Brand Name : EFUDEX
Dosage Strength : 5%
Packaging :
Approval Date : 1982-01-01
Application Number : 16831
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Dosage Form : CREAM;TOPICAL
Brand Name : CARAC
Dosage Strength : 0.5%
Packaging :
Approval Date : 2000-10-27
Application Number : 20985
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : DISCN
Registration Country : USA
Dosage Form : CREAM;TOPICAL
Brand Name : FLUOROURACIL
Dosage Strength : 0.5%
Packaging :
Approval Date : 2015-04-20
Application Number : 203122
Regulatory Info : DISCN
Registration Country : USA

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Regulatory Info : DISCN
Registration Country : USA
Dosage Form : INJECTABLE;INJECTION
Brand Name : IFOSFAMIDE
Dosage Strength : 1GM/20ML (50MG/ML)
Packaging :
Approval Date : 2012-11-26
Application Number : 201689
Regulatory Info : DISCN
Registration Country : USA

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API Manufacturing
API & Drug Product Development
REF. STANDARDS & IMPURITIES
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Extrovis AG is a supplier offers 9 products (APIs, Excipients or Intermediates).
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