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ALISKIREN HEMIFUMARATE

ANDA

ALISKIREN HEMIFUMARATE | A206665 | PH HEALTH LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: TEKTURNA(TE code: AB)

API Supply Chain2 active DMFs2 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

MSN LABORATORIES PRIVATE LTDALISKIREN HEMIFUMARATE [ROUTE CODE - "AF"]

DMF 269752013

JUBILANT PHARMOVA LTDALISKIREN HEMIFUMARATE

DMF 280502014

CHANGZHOU PHARMACEUTICAL FACTORYInactiveALISKIREN HEMIFUMARATE

DMF 247552011

CHEMO IBERICA SAInactiveALISKIREN HEMIFUMARATE

DMF 267762012

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 24, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 150MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Mar 22, 2019

No patent or exclusivity listings for this strength.

#002 — EQ 300MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 22, 2019