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Not in the current Orange Book — This application is not listed in FDA's current Orange Book data files (no listed patents or exclusivities). Product and approval data shown are from FDA's Drugs@FDA database.

THIAMINE HYDROCHLORIDE

ANDANot in Orange Book

THIAMINE HYDROCHLORIDE | A213131 | HONG KONG

API Supply Chain4 active DMFs1 inactive

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

BIOPHORE INDIA PHARMACEUTICALS PVT LTDTHIAMINE HYDROCHLORIDE

DMF 274822013

JIANGXI TIANXIN PHARMACEUTICAL CO LTDTHIAMINE HYDROCHLORIDE

DMF 294612015

DSM-FIRMENICH SWITZERLAND AGTHIAMINE HYDROCHLORIDE

DMF 306342016

JIANGSU BROTHER VITAMINS CO LTDTHIAMINE HYDROCHLORIDE

DMF 327422018

EMCURE PHARMACEUTICALS LTDInactiveTHIAMINE HYDROCHLORIDE USP

DMF 247772011

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

Products (1)

#001 — 100MG/ML

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INJECTABLE;INJECTION | Approved: Sep. 25, 2026

No patent or exclusivity listings for this strength.