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SUCRALFATE

ANDA

SUCRALFATE | A217126 | COSETTE PHARMACEUTICALS NC LABORATORIES LLC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: CARAFATE(TE code: AB)

API Supply Chain11 active DMFs10 inactive

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

FUJI CHEMICAL INDUSTRIES CO LTDSUCRALFATE

DMF 35421979

ACE JAPAN CO LTDSUCRALFATE (SUCROSE SULFATE ALUMINUM SALT)

DMF 61081985

ARCHIMICA SPASUCRALFATE

DMF 165892003

ZHEJIANG HAISEN PHARMACEUTICAL CO LTDSUCRALFATE NON STERILE BULK DRUG SUBSTANCE

DMF 300562016

ALIVUS LIFE SCIENCES LTDSUCRALFATE USP

DMF 334792019

ALIVUS LIFE SCIENCES LTDSUCRALFATE USP (PROCESS-II)

DMF 375022022

MSN LIFE SCIENCES PRIVATE LTDSUCRALFATE USP

DMF 381522023

SNJ LABS PVT LTDSUCRALFATE USP

DMF 388672023

THINQ PHARMA-CRO LTDSUCRALFATE USP

DMF 401452024

GULBRANDSEN TECHNOLOGIES (INDIA) PRIVATE LTDSUCRALFATE USP

DMF 410322024

SNJ LABS PVT LTDSUCRALFATE (SUF) USP

DMF 426412025

ORION CORP LTDInactiveSUCRALFATE

DMF 54541984

ORGAMOL SAInactiveSUCRALFATE

DMF 58251985

NIPPON KAYAKU CO LTDInactiveSUCRALFATE

DMF 60481985

SHANGHAI NO 6 PHARMACEUTICAL FACTORYInactiveSUCRALFATE

DMF 60571985

UNICHEM LABORATORIES LTDInactiveSUCRALFATE

DMF 63311985

ISTITUTO CHEMICOTHERAPICO ITALIANOInactiveSUCRALFATE

DMF 71861987

NANJING PHARMACEUTICAL FACTORY CO LTDInactiveSUCRALFATE

DMF 72821988

NORTHEAST PHARMACEUTICAL GROUP CO LTDInactiveSUCRALFATE

DMF 75521988

SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORPInactiveSUCRALFATE

DMF 78381988

BK GIULINI GMBHInactiveSUCRALFATE POWDER

DMF 118761996

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

Products (1)

#001 — 1GM/10ML

0 patents0 exclusivities▴

SUSPENSION;ORAL | Approved: Nov 13, 2024

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Cosette updated its name from Cosette to Cosette Pharms NC for the sucralfate NDA 217126.

Old: COSETTE

New: COSETTE PHARMS NC

MODIFIEDApplicant Full Name7/1/2026

Cosette Pharmaceuticals Inc updated its legal entity name to Cosette Pharmaceuticals NC Laboratories LLC for the Sucralfate NDA 217126.

Old: COSETTE PHARMACEUTICALS INC

New: COSETTE PHARMACEUTICALS NC LABORATORIES LLC