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APALUTAMIDE

ANDA

APALUTAMIDE | A217113 | ZYDUS LIFESCIENCES GLOBAL FZE

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: ERLEADA(TE code: AB)

API Supply Chain15 active DMFs1 inactive

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

DR REDDYS LABORATORIES LTDAPALUTAMIDE

DMF 346672020

MSN LABORATORIES PRIVATE LTDAPALUTAMIDE

DMF 347112020

DR REDDYS LABORATORIES LTDAPALUTAMIDE (AMORPHOUS)

DMF 357402021

ALEMBIC PHARMACEUTICALS LTDAPALUTAMIDE

DMF 360282021

LAURUS LABS LTDAPALUTAMIDE

DMF 361652021

APITORIA PHARMA PRIVATE LTDAPALUTAMIDE PREMIX

DMF 362542021

ZYDUS LIFESCIENCES LTDAPALUTAMIDE

DMF 362642021

HETERO LABS LTDAPALUTAMIDE

DMF 363942021

AURISCO PHARMACEUTICAL CO LTDAPALUTAMIDE

DMF 398902024

BEIJING HOPE PHARMACEUTICAL CO LTDAPALUTAMIDE

DMF 403622024

HETERO LABS LTDAPALUTAMIDE PREMIX

DMF 409272024

HUBEI GEDIAN HUMANWELL PHARMACEUTICAL CO LTDAPALUTAMIDE

DMF 410622025

MSN LABORATORIES PRIVATE LTDAPALUTAMIDE [ROUTE CODE AEL]

DMF 417002025

SICHUAN KELUN PHARMACEUTICAL CO LTDAPALUTAMIDE

DMF 420302025

ZHEJIANG HISUN PHARMACEUTICAL CO LTDAPALUTAMIDE

DMF 432862025

PORTON PHARMA SOLUTIONS LTDInactiveAPALUTAMIDE

DMF 390292023

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

Products (1)

#001 — 60MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Mar 17, 2025

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Zydus corrected its applicant name from "ZYDUS" to "ZYDUS LIFESCIENCES" for apalutamide NDA 217113.

Old: ZYDUS

New: ZYDUS LIFESCIENCES

MODIFIEDApplicant Full Name7/1/2026

Zydus Worldwide DMCC changed its corporate name to Zydus Lifesciences Global FZE for NDA 217113 (apalutamide).

Old: ZYDUS WORLDWIDE DMCC

New: ZYDUS LIFESCIENCES GLOBAL FZE