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CALCIUM GLUCONATE IN SODIUM CHLORIDE

ANDA

CALCIUM GLUCONATE | A217174 | AMNEAL EU LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: CALCIUM GLUCONATE(TE code: AP)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
HQ Specialty Pharma Corp. et al v. Amneal Pharmaceuticals LLC 1:2023cv01135 1 patentANDA 217174calcium gluconate in sodium chloride	D. Del.	2023-10-11	Terminated 2025-08-12	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain16 active DMFs1 inactive

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

GLOBAL CALCIUM PRIVATE LTDCALCIUM GLUCONATE MONOHYDRATE FOR INJECTION

DMF 294322015

TOMITA PHARMACEUTICAL CO LTDCALCIUM GLUCONATE MONOHYDRATE USP

DMF 316902017

ZHEJIANG RUIBANG LABORATORIESCALCIUM GLUCONATE FOR INJECTION

DMF 347482021

VASA PHARMACHEM PVT LTDCALCIUM GLUCONATE IP/BP/EP/USP

DMF 359402021

RAKS PHARMA PVT LTDCALCIUM GLUCONATE MONOHYDRATE USP

DMF 369382022

EXTROVIS AGCALCIUM GLUCONATE

DMF 372132023

ZYDUS LIFESCIENCES LTDCALCIUM GLUCONATE MONOHYDRATE USP

DMF 389692023

JIANGXI YBN PHARMACEUTICAL CO LTDCALCIUM GLUCONATE AND ZINC GLUCONATE

DMF 394332024

BIOPHORE INDIA PHARMACEUTICALS PVT LTDCALCIUM GLUCONATE MONOHYDRATE

DMF 396012024

HOSTER LABS PRIVATE LTDCALCIUM GLUCONATE MONOHYDRATE

DMF 400312024

MUBY CHEM PRIVATE LTDCALCIUM GLUCONATE MONOHYDRATE USP

DMF 411422025

GLOBAL CALCIUM PRIVATE LTDCALCIUM GLUCONATE USP (FOR INJECTION) MONOHYDRATE

DMF 424202025

JIANGXI XINGANJIANG PHARMACEUTICAL CO LTDCALCIUM GLUCONATE FOR INJECTION

DMF 425222025

JIANGXI XINGANJIANG PHARMACEUTICAL CO LTDCALCIUM GLUCONATE FOR ORAL USE

DMF 425232025

STHREE CHEMICALS PRIVATE LTDCALCIUM GLUCONATE USP

DMF 427052025

CIPLA LTDCALCIUM GLUCONATE MONOHYDRATE USP

DMF 428272025

PURAC BIOCHEM BVInactiveCALCIUM GLUCONATE

DMF 84381990

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Oct 27, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 1GM/50ML (20MG/ML)

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Sep 5, 2023

No patent or exclusivity listings for this strength.

#002 — 2GM/100ML (20MG/ML)

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Sep 5, 2023