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DOXORUBICIN HYDROCHLORIDE

ANDA

DOXORUBICIN HYDROCHLORIDE | A219881 | QILU PHARMACEUTICAL HAINAN CO LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: DOXIL (LIPOSOMAL)(TE code: AB)

API Supply Chain11 active DMFs2 inactive

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

PHARMACIA AND UPJOHN CO WHOLLY OWNED SUB PFIZER INCDOXORUBICIN HYDROCHLORIDE

DMF 20981973

MEIJI SEIKA PHARMA CO LTDDOXORUBICIN HYDROCHLORIDE DRUG SUBSTANCE

DMF 132091998

MICROBIOPHARM JAPAN CO LTDDOXORUBICIN HYDROCHLORIDE

DMF 132111998

TAPI NL BVDOXORUBICIN HYDROCHLORIDE

DMF 137261998

ZHEJIANG HISUN PHARMACEUTICAL CO LTDDOXORUBICIN HYDROCHLORIDE USP

DMF 137731998

SYNBIAS PHARMA AGDOXORUBICIN HYDROCHLORIDE

DMF 161782002

STERLING BIOTECH LTDDOXORUBICIN HYDROCHLORIDE(API)

DMF 248582011

ZHEJIANG HISUN PHARMACEUTICAL CO LTDDOXORUBICIN HYDROCHLORIDE USP (FERMENTATION)

DMF 273112013

OLON SPADOXORUBICIN HYDROCHLORIDE

DMF 300352015

DZD (HEZE) PHARMACEUTICAL CO LTDDOXORUBICIN HYDROCHLORIDE

DMF 311532016

INTAS PHARMACEUTICALS LTDDOXORUBICIN HYDROCHLORIDE USP

DMF 345452020

CHEMWERTH INCInactiveDOXORUBICIN HYDROCHLORIDE USP (NON-STERILE, BULK DRUG SUBSTANCE)

DMF 184622005

RPG LIFE SCIENCES LTDInactiveDOXORUBICIN HYDROCHLORIDE USP/EP

DMF 241282010

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

Products (2)

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#001 — 20MG/10ML (2MG/ML)

0 patents0 exclusivities▴

INJECTABLE, LIPOSOMAL;INJECTION | Approved: Feb 3, 2026

No patent or exclusivity listings for this strength.

#002 — 50MG/25ML (2MG/ML)

0 patents0 exclusivities▾

INJECTABLE, LIPOSOMAL;INJECTION | Approved: Feb 3, 2026