Viewing data from:

CLOFARABINE

ANDA

CLOFARABINE | A210270 | INGENUS PHARMACEUTICALS LLC

1 strength0 unique patents0 unique exclusivities

API Supply Chain10 active DMFs2 inactive

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

MATRIX PHARMACORP PRIVATE LTDCLOFARABINE

DMF 256332012

OLON SPACLOFARABINE

DMF 266352012

SCINOPHARM TAIWAN LTDCLOFARABINE

DMF 275662014

EMCURE PHARMACEUTICALS LTDCLOFARABINE

DMF 277972013

MSN LABORATORIES PRIVATE LTDCLOFARABINE [ROUTE CODE "CF"]

DMF 278622014

BIOPHORE INDIA PHARMACEUTICALS PVT LTDCLOFARABINE

DMF 279012014

SUN PHARMACEUTICAL INDUSTRIES LTDCLOFARABINE

DMF 293182015

GUANGZHOU HENOVCOM BIOSCIENCE CO LTDCLOFARABINE

DMF 297062015

SHILPA PHARMA LIFESCIENCES LTDCLOFARABINE

DMF 298062015

ALEMBIC PHARMACEUTICALS LTDCLOFARABINE

DMF 350332020

SYNBIAS PHARMA AGInactiveCLOFARABINE

DMF 293722015

QILU PHARMACEUTICAL CO LTDInactiveCLOFARABINE

DMF 297692015

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

Products (1)

#001 — 20MG/20ML (1MG/ML)

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Sep 14, 2018

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

INGENUS PHARMS LLC acquired the applicant status for clofarabine (NDA 210270) from NOVAST LABS.

Old: NOVAST LABS

New: INGENUS PHARMS LLC

MODIFIEDApplicant Full Name7/1/2026

INGENUS PHARMACEUTICALS LLC acquired rights to clofarabine (NDA 210270), replacing NOVAST LABORATORIES LTD as the listed applicant.

Old: NOVAST LABORATORIES LTD

New: INGENUS PHARMACEUTICALS LLC