Overview

MEDILUX LABORATORIES PVT LTD is an active pharmaceutical ingredient (API) supplier with 14 active FDA Type II Drug Master Files, covering 3-(4-CHLOROPHENYL) GLUTARIC ANHYDRIDE; 4-(2--PIPERIDINOETHOXY) BENZOIC ACID HYDROCHLORIDE; 6-HYDROXY-2-(4-HYDROXYPHENYL)-BENZO[B]THIOPHENE; BACLOFEN; BISOPROLOL FUMARATE; BROENAC SODIUM HYDRATE.

API / Drug Master Files

MEDILUX LABORATORIES PVT LTD holds 14 active (16 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.

  • BUMETANIDE USPActive2025-05-26
  • BROENAC SODIUM HYDRATEActive2024-09-20
  • BUSPIRONE HYDROCHLORIDE USPActive2024-07-24
  • GLIMEPIRIDE USPActive2024-07-11
  • TRAZODONE HYDROCHLORIDE USPActive2024-02-13
  • RALOXIFENE HYDROCHLORIDE USPActive2023-11-29
  • DAPSONE USPActive2023-06-05
  • BISOPROLOL FUMARATEActive2021-04-08
  • TORSEMIDEActive2021-03-20
  • BACLOFENActive2021-02-25
  • 3-(4-CHLOROPHENYL) GLUTARIC ANHYDRIDEActive2018-07-06
  • 4-(2--PIPERIDINOETHOXY) BENZOIC ACID HYDROCHLORIDEActive2017-11-02
  • 6-HYDROXY-2-(4-HYDROXYPHENYL)-BENZO[B]THIOPHENEActive2017-11-02
  • DEFERASIROXActive2016-06-29
  • TRAZODONE HYDROCHLORIDE USPInactive2022-09-02

Showing 15 of 16 Drug Master Files.

FDA compliance signals

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

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