ARCH PHARMALABS LTD

Overview

ARCH PHARMALABS LTD is an active pharmaceutical ingredient (API) supplier with 67 active FDA Type II Drug Master Files, covering (DKT -III) 4-FLUORO- ALPHA- [2-METHYL-1 -OXO- PROPYL]-Y-OXO-N-BETA- DIPHENYL BENZENE BUTANAMIDE; 1-[[2-(4-CHLOROPHENYL)-4, 4-DIMETHYL-CYCLOHEXEN-1-YL]-METHYL]- PIPERAZINE (VP-008 BASE); 1-{[2-(4-CHLOROPHENYL)-4, 4-DIMETHYLCYCLOHEX-1-ENYL]-METHYL}- PIPERAZINE DIHYDROCHLORIDE (VP-008); 2-(2-HYDROXPHENYL)-4H-BENZO[E][1,3]OXAZIN-4-ONE (DFR-I); 3-NITRO-4-(((TETRAHYDRO-2H-PYRAN-4-YL) METHYL) AMINO) BENZENESULFONAMIDE; 4-FLUORO-2-(1H-PYRROLO[2,3-B]PYRIDIN-5-YLOXY]-BENZOIC ACID METHYL ESTER (PR-2017-015-III).

API / Drug Master Files

ARCH PHARMALABS LTD holds 67 active (79 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.

• TERT-BUTYL 4-(6AMINOPYRIDIN-3-YL)PIPERAZINE-1-CARBOXYLATE (VP-004)Active2026-03-09
• 2-(2-HYDROXPHENYL)-4H-BENZO[E][1,3]OXAZIN-4-ONE (DFR-I)Active2026-02-25
• MIRABEGRONActive2025-10-20
• PHENYLEPHRINE HYDROCHLORIDEActive2025-10-14
• EMPAGLIFLOZINActive2025-09-30
• SITAGLIPTIN PHOSPHATE ANHYDROUSActive2025-06-23
• PALBOCICLIBActive2025-04-14
• CAFFEINE (ANHYDROUS)Active2025-03-31
• DEFERIPRONEActive2024-04-16
• CYCLOPHOSPHAMIDEActive2022-05-02
• 5-BROMO-1-(2-FLUORO-6-(TRIFLUOROMETHYL)BENZYL)-6-METHYLPYRIMIDINE-2,4(1H,3H)-DIONE (PR-419)Active2022-02-25
• TERT-BUTYL-[(3S)-3-AMINO-2-OXO-2,3,4,5-TETRAHYDRO-1H-1-BENZAZEPIN-1-YL] ACETATE (PR-415)Active2022-02-25
• APIXABANActive2021-07-01
• ENZALUTAMIDEActive2021-04-28
• BENZYL(2S)-2-(8-AMINO-1-BROMOIMIDAZO[1,5-A]PYRAZIN-3-YL)PYRROLIDINE-1-CARBOXYLATE(VP-023)Active2021-04-20

Showing 15 of 79 Drug Master Files.

FDA compliance signals

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