SPECGX LLC

Overview

SPECGX LLC is an active pharmaceutical ingredient (API) supplier with 67 active FDA Type II Drug Master Files, covering ACETAMINOPHEN USP; AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; BUPRENORPHINE BASE EP, CODE 3205; BUPRENORPHINE HYDROCHLORIDE USP, CODE 3210; CHLORPHENIRAMINE POLISTIREX.

API / Drug Master Files

SPECGX LLC holds 67 active (76 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.

• DEXTROAMPHETAMINE SACCHARATE NPActive2025-08-28
• DEXTROAMPHETAMINE SULFATE USP NPActive2025-08-28
• NALMEFENE BASEActive2021-11-10
• LISDEXAETAMINE DIMESYLATEActive2020-05-29
• SUFENTANIL BASE EPActive2017-08-23
• PARACETAMOL DC (PVP) 284NActive2017-02-24
• SUFENTANIL CITRATE USP/EPActive2016-12-19
• DEXMETHYLPHENIDATE HYDROCHLORIDEActive2016-10-07
• HYDROCODONE BASE (NP)Active2015-12-03
• METHADONE HYDROCHLORIDE USPActive2015-09-29
• HYDROCODONE BITARTRATE USP CRYSTALS (NP)Active2013-10-31
• METHYLPHENIDATE HYDROCHLORIDE USP (NP)Active2013-09-30
• DEXTROMETHADONE HYDROCHLORIDEActive2013-09-30
• COMPAP SDCRSLActive2013-07-10
• NORBUPRENORPHINE HYDROCHLORIDEActive2012-11-27

Showing 15 of 76 Drug Master Files.

FDA compliance signals

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