Viewing data from:

GLYCEROL PHENYLBUTYRATE

ANDA

GLYCEROL PHENYLBUTYRATE | A220313 | AUROBINDO PHARMA LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: RAVICTI(TE code: AA)

API Supply Chain7 active DMFs

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

NURAY CHEMICALS PRIVATE LTDGLYCEROL PHENYLBUTYRATE

DMF 271252013

LUPIN MANUFACTURING SOLUTIONS LTDGLYCEROL PHENYLBUTYRATE

DMF 282982014

HETERO DRUGS LTDGLYCEROL PHENYLBUTYRATE

DMF 344682020

MSN LABORATORIES PRIVATE LTDGLYCEROL PHENYLBUTYRATE

DMF 346182020

TAPI NL BVGLYCEROL PHENYLBUTYRATE

DMF 370422022

APITORIA PHARMA PRIVATE LTDGLYCEROL PHENYLBUTYRATE

DMF 403882024

NAVINTA LLCGLYCEROL PHENYLBUTYRATE

DMF 409662025

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 11, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1.1GM/ML

0 patents0 exclusivities▴

LIQUID;ORAL | Approved: Apr 15, 2026

No patent or exclusivity listings for this strength.