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BIVALIRUDIN

ANDA

BIVALIRUDIN | A213078 | HAINAN POLY PHARM CO LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: ANGIOMAX(TE code: AP)

API Supply Chain11 active DMFs3 inactive

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

AMBIOPHARM INCBIVALIRUDIN, NON-STERILE BULK DRUG SUBSTANCE

DMF 208532007

TAPI NL BVBIVALIRUDIN

DMF 208632007

DR REDDYS LABORATORIES LTDBIVALIRUDIN

DMF 236562010

ALP PHARM BEIJING CO LTDBIVALIRUDIN

DMF 242572010

SUN PHARMACEUTICAL INDUSTRIES LTDBIVALIRUDIN

DMF 244232011

CHENGDU SHENGNUO BIOPHARM CO LTDBIVALIRUDIN (NON-STERILE BULK DRUG)

DMF 255312012

SCINOPHARM TAIWAN LTDBIVALIRUDIN

DMF 256342011

HAINAN SHUANGCHENG PHARMACEUTICALS CO LTDBIVALIRUDIN

DMF 300712016

SHENZHEN SALUBRIS PHARMACEUTICALS CO LTDBIVALIRUDIN

DMF 302152016

BACHEM AGBIVALIRUDIN

DMF 314582017

SINOPEP-ALLSINO BIOPHARMACEUTICAL CO LTDBIVALIRUDIN

DMF 322812018

HYBIO PHARMACEUTICAL CO LTDInactiveBIVALIRUDIN, NON-STERILE BULK DRUG SUBSTANCE

DMF 251652011

POLYPEPTIDE SAInactiveBIVALIRUDIN (TM-001-2G)

DMF 289122014

SINOPEP-ALLSINO BIOPHARMACEUTICAL CO LTDInactiveBIVALIRUDIN (PROCESS II)

DMF 352592020

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

Products (1)

#001 — 250MG/VIAL

0 patents0 exclusivities▴

INJECTABLE;INTRAVENOUS | Approved: May 28, 2021

No patent or exclusivity listings for this strength.