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MELPHALAN HYDROCHLORIDE

ANDA

MELPHALAN HYDROCHLORIDE | A210947 | INGENUS PHARMACEUTICALS LLC

1 strength0 unique patents0 unique exclusivities

API Supply Chain9 active DMFs2 inactive

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

OLON SPAMELPHALAN HYDROCHLORIDE

DMF 208832007

EMCURE PHARMACEUTICALS LTDMELPHALAN HYDROCHLORIDE

DMF 250402011

FARMABIOS SPAMELPHALAN HYDROCHLORIDE

DMF 257912012

NERPHARMA SRLMELPHALAN HYDROCHLORIDE DRUG SUBSTANCE

DMF 273062013

BIOPHORE INDIA PHARMACEUTICALS PVT LTDMELPHALAN HYDROCHLORIDE

DMF 274852013

SHILPA PHARMA LIFESCIENCES LTDMELPHALAN HYDROCHLORIDE (MPH)

DMF 289302015

HETERO LABS LTDMELPHALAN HYDROCHLORIDE

DMF 295372015

NAVINTA LLCMELPHALAN HYDROCHLORIDE

DMF 297662015

APITORIA PHARMA PRIVATE LTDMELPHALAN HYDROCHLORIDE

DMF 371792022

XIAN LIBANG PHARMACEUTICAL CO LTDInactiveMELPHALAN HYDROCHLORIDE (NON STERILE BULK DRUG SUBSTANCE)

DMF 236672010

GRANULES INDIA LTDInactiveMELPHALAN HYDROCHLORIDE

DMF 360962021

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

Products (1)

#001 — EQ 50MG BASE/VIAL

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Feb 18, 2020

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Applicant for melphalan hydrochloride (NDA 210947) changed from Novast Labs to Ingenus Pharms LLC.

Old: NOVAST LABS

New: INGENUS PHARMS LLC

MODIFIEDApplicant Full Name7/1/2026

Ingenus Pharmaceuticals LLC became the listed applicant for melphalan hydrochloride (NDA 210947) following a change from Novast Laboratories Ltd.

Old: NOVAST LABORATORIES LTD

New: INGENUS PHARMACEUTICALS LLC