CHATTEM CHEMICALS INC

Overview

CHATTEM CHEMICALS INC is an active pharmaceutical ingredient (API) supplier with 28 active FDA Type II Drug Master Files, covering AMINOACETIC ACID (GLYCINE); AMMONIUM LACTATE; AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE USP; BENZPHETAMINE HYDROCHLORIDE; BUPRENORPHINE HYDROCHLORIDE USP.

API / Drug Master Files

CHATTEM CHEMICALS INC holds 28 active (30 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.

• SODIUM OXYBATEActive2025-02-28
• DEXTROAMPHETAMINE SACCHARATEActive2025-01-21
• AMPHETAMINE ASPARTATE MONOHYDRATEActive2024-06-28
• CODEINE PHOSPHATE HEMIHYDRATE, USPActive2022-05-02
• BUPRENORPHINE HYDROCHLORIDE USPActive2021-02-26
• DIHYDROCODEINE BITARTRATE USPActive2019-09-27
• AMPHETAMINE SULFATE USPActive2018-11-16
• LISDEXAETAMINE DIMESYLATEActive2018-05-18
• DEXTROAMPHETAMINE BASEActive2018-03-14
• DEXTROAMPHETAMINE SULFATE USPActive2017-02-03
• HYDROMORPHONE HYDROCHLORIDE, USPActive2016-11-23
• HYDROCODONE BITARTRATE USPActive2015-04-01
• METHADONE HYDROCHLORIDE USPActive2012-05-09
• OXYCODONE HYDROCHLORIDE, USPActive2010-06-30
• FENTANYL CITRATE USPActive2009-10-26

Showing 15 of 30 Drug Master Files.

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to CHATTEM CHEMICALS INC in our records. PharmaTek screens the full directory against live FDA enforcement data.