AMOLI ORGANICS PRIVATE LTD

Overview

AMOLI ORGANICS PRIVATE LTD is an active pharmaceutical ingredient (API) supplier with 50 active FDA Type II Drug Master Files, covering (2R,3R)-3(3-METHOXY PHENYL)-N,N,2-TRIMETHYL PENTANE-1-AMINE HYDROCHLORIDE [ROUTE CODE TPT4]; 4-OXO-1,4-DIHYDROQUINOLINE-3-CARBOXYLIC ACID [STARTING MATERIAL OF IVACAFTOR]; AMINO PHENOL DERIVATIVE [STARTING MATERIAL OF IVACATOR]; ASCORBIC ACID USP; ASENAPINE MALEATE [ROUTE CODE "AOI"]; ASENAPINE MALEATE [ROUTE CODE AN].

API / Drug Master Files

AMOLI ORGANICS PRIVATE LTD holds 50 active (58 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.

• LANSOPRAZOLE USPActive2025-03-28
• TAPENTADOL HYDROCHLORIDEActive2025-02-28
• TAPINAROFActive2024-11-28
• FOSFOMYCIN SODIUMActive2024-09-29
• BELUMOSUDIL MESYLATEActive2024-09-29
• FOSFOMYCIN TROMETHAMINE USPActive2024-09-27
• VIBEGRONActive2024-09-24
• MIRABEGRONActive2023-09-15
• TRIENTINE TETRAHYDROCHLORIDEActive2023-03-30
• RIVASTIGMINE USPActive2022-01-31
• SERTRALINE HYDROCHLORIDE USPActive2021-10-15
• VENLAFAXINE HYDROCHLORIDE (FORM-B)Active2021-07-29
• RIVASTIGMINE TARTRATE USPActive2021-03-31
• 4-OXO-1,4-DIHYDROQUINOLINE-3-CARBOXYLIC ACID [STARTING MATERIAL OF IVACAFTOR]Active2021-02-09
• PERAMPANEL (3/4 HYDRATE)Active2021-02-01

Showing 15 of 58 Drug Master Files.

FDA compliance signals

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