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REGORAFENIB

ANDA

REGORAFENIB | A209728 | ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC

1 strength0 unique patents0 unique exclusivities

API Supply Chain8 active DMFs

7 active API suppliers hold Drug Master Files for this ingredient.

MSN LABORATORIES PRIVATE LTDREGORAFENIB [ROUTE CODE "RZ"]

DMF 298702015

HETERO LABS LTDREGORAFENIB

DMF 304902016

MSN LABORATORIES PRIVATE LTDREGORAFENIB MONOHYDRATE USP

DMF 368382022

CHONGQING CARELIFE PHARMACEUTICAL CO LTDREGORAFENIB

DMF 381972023

ZHEJIANG HUAYI PHARMACEUTICAL CO LTDREGORAFENIB

DMF 398982024

YANGTZE RIVER PHARMACEUTICAL GROUP JIANGSU HAICI BIOLOGICAL PHARMACEUTICAL CO LTDREGORAFENIB ANHYDRATE NON-STERILE DRUG SUBSTANCE

DMF 412902025

SHANDONG ANHONG PHARMACEUTICAL CO LTDREGORAFENIB

DMF 415962025

SICHUAN KELUN PHARMACEUTICAL CO LTDREGORAFENIB

DMF 428422025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 19, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 40MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jan 13, 2025

No patent or exclusivity listings for this strength.