SPECGX LLC

United States

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.

Core services & business areas

API ManufacturingPharmaceutical Manufacturing

Active pharmaceutical ingredients supplied

Substances SPECGX LLC is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.

ParacetamolLeuprolide AcetateMethylphenidateBuprenorphineDesmopressinHydrocodoneFentanylLeuprolideBuprenorphine HydrochlorideNaloxoneOxycodoneDextroamphetamine SaccharateAmphetamine AspartateMethadoneCodeineNalmefene HydrochlorideHydromorphoneNaltrexone HydrochlorideDextroamphetamineDiphenoxylateExenatideLisdexamfetamine DimesylateMethylnaltrexone BromideCodeine PhosphateMorphine SulfateDexmethylphenidate HydrochlorideAmphetamine SulfateOxymorphoneLevorphanolIothalamic AcidIoversolMeperidineMethylphenidate HydrochlorideSufentanilCocaineHydromorphone HydrochlorideNalbuphineMethylnaltrexoneNoscapineHydrocodone Polistirex

API / Drug Master Files

SPECGX LLC holds 66 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
  • LISDEXAMFETAMINE 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

7 FDA enforcement records linked to this company.

  • recall — Class II2026-01-14

    Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.

  • recall — Class II2026-01-14

    Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.

  • 4832016-01-29

    Storage under appropriate conditions

  • 4832016-01-29

    Accurate reproduction included

  • 4832013-08-30

    Establishment of time limitations

  • 4832013-08-30

    SOPs not followed / documented

  • 4832013-08-30

    Approval and review of procedures

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