Viewing data from:

CARMUSTINE

ANDA

CARMUSTINE | A211011 | INGENUS PHARMACEUTICALS LLC

1 strength0 unique patents0 unique exclusivities

API Supply Chain12 active DMFs1 inactive

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

JOHNSON MATTHEY PHARMACEUTICAL MATERIALSCARMUSTINE

DMF 102901993

AMPAC FINE CHEMICALS LLCCARMUSTINE (BCNU)

DMF 131691998

CHEMPACIFIC CORPCARMUSTINE DRUG SUBSTANCE

DMF 226372009

EMCURE PHARMACEUTICALS LTDCARMUSTINE USP

DMF 229052009

AGNO PHARMACARMUSTINE USP

DMF 301842017

MSN LABORATORIES PRIVATE LTDCARMUSTINE USP

DMF 311562016

JIANGSU HENGRUI PHARMACEUTICALS CO LTDCARMUSTINE USP NON STERILE BULK DRUG SUBSTANCE

DMF 320312017

APITORIA PHARMA PRIVATE LTDCARMUSTINE USP

DMF 323432017

NERPHARMA SRLCARMUSTINE DRUG SUBSTANCE

DMF 329222018

INTAS PHARMACEUTICALS LTDCARMUSTINE USP

DMF 337302019

NATCO PHARMA LTDCARMUSTINE

DMF 345472020

VANNSH LIFE SCIENCES PRIVATE LTDCARMUSTINE USP

DMF 386862023

BRISTOL LABORATORIES INC DIV BRISTOL MYERS COInactiveCARMUSTINE (BCNU) BULK & CARMUSTINE (BCNU) FOR INJ

DMF 20381973

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

Products (1)

#001 — 100MG/VIAL

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jun 21, 2022

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

INGENUS PHARMS LLC replaced NOVAST LABS as the applicant for Carmustine (NDA 211011), reflecting a change in product ownership or sponsorship.

Old: NOVAST LABS

New: INGENUS PHARMS LLC

MODIFIEDApplicant Full Name7/1/2026

INGENUS PHARMACEUTICALS LLC acquired the NDA for Carmustine (carmustine) from Novast Laboratories Ltd, as reflected in the applicant change for application 211011.

Old: NOVAST LABORATORIES LTD

New: INGENUS PHARMACEUTICALS LLC