Viewing data from:

L-GLUTAMINE

ANDA

L-GLUTAMINE | A219722 | ANNORA PHARMA PRIVATE LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: ENDARI(TE code: AA)

API Supply Chain6 active DMFs1 inactive

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

AJINOMOTO DO BRASIL INDUSTRIA E COMERCIO DE ALIMENTOS LTDAL-GLUTAMINE

DMF 196732006

FUJIFILM IRVINE SCIENTIFIC INCL-GLUTAMINE (200MM)- LIQUID

DMF 279512014

SS PHARMA LLCL-GLUTAMINE USP

DMF 360822021

BIOPHORE INDIA PHARMACEUTICALS PVT LTDL-GLUTAMINE

DMF 376952022

HOSTER LABS PRIVATE LTDL-GLUTAMINE

DMF 388182023

METROCHEM API PRIVATE LTDL-GLUTAMINE USP

DMF 389922023

TANABE SEIYAKU CO LTDInactiveL-GLUTAMINE

DMF 18331971

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

Products (1)

#001 — 5GM/PACKET

0 patents0 exclusivities▴

FOR SOLUTION;ORAL | Approved: May 26, 2026

No patent or exclusivity listings for this strength.

Change History (1)

Recent changes detected for this application.

ADDED7/1/2026

Annora Pharma's L-glutamine formulation (NDA 219722) added to FDA drug database, establishing initial regulatory record for this product.

New: New record