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).

Core services & business areas

Active pharmaceutical ingredients supplied

Substances ARCH PHARMALABS LTD 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.

API / Drug Master Files

ARCH PHARMALABS LTD holds 16 active (28 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.

• URSODIOL USPActive2018-12-17
• CLOPIDOGREL CAMPHOR SULPHONATE SALTActive2011-11-19
• ATV-1/(4R-CIS)-1, 1-DIMETHYLETHYL 6-{2[2-(4-FLUOROPHENYL)-5-(1-METHYLETHYL)-3-PHENYL-4[(PHENYLAMINO) CARBONYL]-1 H-PYRROL-1-YL]ETHYL}-2,2-DIMETHYL-1,3-DIOXAN-4-ACETATEActive2011-05-09
• IRINOTECAN HYDROCHLORIDE TRIHYDRATE USPActive2011-05-06
• TTP.HCL / 4,5,6,7-TETRAHYDROTHIENO (3,2-C) PYRIDINE HYDROCHLORIDEActive2011-03-11
• ATS-8 / (4R-CIS)-1, 1-DIMETHYLETHYL-6-CYANOMETHYL-2,2-DIMETHYL-1,3-DIOXANE-4-ACETATEActive2011-01-12
• ATORVASTATIN CALCIUM CRYSTALLINE USP (ATVR)Active2010-12-01
• (DKT -III) 4-FLUORO- ALPHA- [2-METHYL-1 -OXO- PROPYL]-Y-OXO-N-BETA- DIPHENYL BENZENE BUTANAMIDEActive2010-09-13
• BENZTROPINE MESYLATE USPActive2010-06-04
• GEMCITABINE HYDROCHLORIDE USP (CODE: GMI)Active2010-05-26
• AMLODIPINE BESYLATE USPActive2010-05-21
• GEMCITABINE HYDROCHLORIDE USPActive2010-03-31
• CITALOPRAM HYDROBROMIDE USP (CYANO ROUTE)Active2010-03-03
• ESCITALOPRAM OXALATEActive2006-06-20
• MELOXICAM USPActive2002-04-05

Showing 15 of 28 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.