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CETRORELIX ACETATE

ANDA

CETRORELIX ACETATE | A218740 | EPIC PHARMA LLC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: CETROTIDE(TE code: AP)

API Supply Chain10 active DMFs

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

MERCK HEALTHCARE KGAACETRORELIX ACETATE BULK DRUG SUBSTANCE

DMF 180772005

ALP PHARM BEIJING CO LTDCETRORELIX ACETATE

DMF 339142019

PIRAMAL PHARMA LTDCETRORELIX

DMF 345522020

SUN PHARMACEUTICAL INDUSTRIES LTDCETRORELIX ACETATE

DMF 347042020

BIOPHORE INDIA PHARMACEUTICALS PVT LTDCETRORELIX ACETATE

DMF 347522020

CHINESE PEPTIDE COCETRORELIX ACETATE

DMF 348842020

SINOPEP-ALLSINO BIOPHARMACEUTICAL CO LTDCETRORELIX ACETATE

DMF 351712020

BCN PEPTIDES SACETRORELIX

DMF 382642023

HARBIN JIXIANGLONG BIOTECH CO LTDCETRORELIX ACETATE

DMF 399862024

APICORE LLC (A WHOLLY OWNED SUB OF RK PHARMA INC)CETRORELIX ACETATE

DMF 418542025

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

Products (1)

#001 — EQ 0.25MG BASE/VIAL

0 patents0 exclusivities▴

POWDER;SUBCUTANEOUS | Approved: Apr 29, 2026

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Epic Pharma LLC became the applicant for Cetrorelix Acetate (NDA 218740) following a change from Humanwell.

Old: HUMANWELL

New: EPIC PHARMA LLC

MODIFIEDApplicant Full Name7/1/2026

Cetrorelix Acetate (NDA 218740) applicant changed from Humanwell Pharmaceutical US Inc to Epic Pharma LLC.

Old: HUMANWELL PHARMACEUTICAL US INC

New: EPIC PHARMA LLC