Viewing data from:

ERIBULIN MESYLATE

ANDA

ERIBULIN MESYLATE | A217085 | NATCO PHARMA LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: HALAVEN(TE code: AP)

API Supply Chain12 active DMFs

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

EUROFINS CDMO ALPHORA INCERIBULIN MESYLATE

DMF 334252019

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDERIBULIN MESYLATE

DMF 351182020

FORMOSA LABORATORIES INCERIBULIN MESYLATE

DMF 353582020

WISDOM PHARMACEUTICAL CO LTDERIBULIN MESYLATE

DMF 355232021

DR REDDYS LABORATORIES LTDERIBULIN MESYLATE

DMF 364332021

NATCO PHARMA LTDERIBULIN MESYLATE

DMF 366052022

EMCURE PHARMACEUTICALS LTDERIBULIN MESYLATE

DMF 365662021

ZHEJIANG RAYBOW PHARMACEUTICAL CO LTDERIBULIN MESYLATE

DMF 373882022

CHONGQING SINTAHO PHARMACEUTICAL CO LTDERIBULIN MESYLATE

DMF 375592023

XILING LAB CO LTDERIBULIN MESYLATE

DMF 376292022

FINETECH PHARMACEUTICAL LTDERIBULIN MESYLATE DRUG SUBSTANCE

DMF 377692024

ZENJI PHARMACEUTICALS (SUZHOU) LTDERIBULIN MESYLATE

DMF 386982023

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

Products (1)

#001 — 1MG/2ML (0.5MG/ML)

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Jun 1, 2026

No patent or exclusivity listings for this strength.

Change History (1)

Recent changes detected for this application.

ADDED7/1/2026

Natco's eribulin mesylate product (NDA 217085) received FDA approval for marketing.

New: New record