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ALENDRONATE SODIUM

ANDA

ALENDRONATE SODIUM | A214523 | PRECISION DOSE INC

1 strength0 unique patents0 unique exclusivities

API Supply Chain10 active DMFs8 inactive

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

CIPLA LTDALENDRONATE SODIUM USP

DMF 143341999

APOTEX INCALENDRONATE SODIUM TRIHYDRATE USP

DMF 154092001

APITORIA PHARMA PRIVATE LTDALENDRONATE SODIUM USP (NON-STERILE DRUG SUBSTANCE)

DMF 200312006

DR REDDYS LABORATORIES LTDALENDRONATE SODIUM

DMF 201002006

MATRIX PHARMACORP PRIVATE LTDALENDRONATE SODIUM USP (TRIHYDRATE)

DMF 204022007

ORCHID PHARMA LTDALENDRONATE SODIUM TRIHYDRATE

DMF 204152007

SUN PHARMACEUTICAL INDUSTRIES LTDALENDRONATE SODIUM USP

DMF 207862007

IPCA LABORATORIES LTDALENDRONATE SODIUM USP

DMF 210082007

JUBILANT PHARMOVA LTDALENDRONATE SODIUM USP

DMF 223332009

MINSHENG GROUP SHAOXING PHARMACEUTICAL CO LTDALENDRONATE SODIUM

DMF 261092012

ALCHYMARS SPAInactiveALENDRONATE SODIUM

DMF 149832000

SIGNA SA DE CVInactiveALENDRONATE SODIUM TRIHYDRATE USP

DMF 161292002

MEDICHEM SAInactiveALENDRONATE SODIUM

DMF 163672003

SHIJIAZHUANG PHARMACEUTICAL GROUP HUASHENG PHARMA CO LTDInactiveALENDRONATE SODIUM USP 28

DMF 185772005

LUPIN LTDInactiveALENDRONATE SODIUM USP

DMF 192992006

ALEMBIC PHARMACEUTICALS LTDInactiveALENDRONATE SODIUM USP

DMF 206512007

CHONGQING CARE LIFE PHARMACEUTICAL CO LTDInactiveALENDRONATE SODIUM NON-STERILE BULK DRUG SUBSTANCE

DMF 231692009

CTX LIFE SCIENCES PVT LTDInactiveALENDRONATE SODIUM USP

DMF 258282012

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 4, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 70MG BASE/75ML

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Sep 2, 2026

No patent or exclusivity listings for this strength.