AMOLI ORGANICS (A DIVISION OF UMEDICA LABORATORIES PVT LTD)

Overview

AMOLI ORGANICS (A DIVISION OF UMEDICA LABORATORIES PVT LTD) is an active pharmaceutical ingredient (API) supplier with 33 active FDA Type II Drug Master Files, covering APIXABAN; CARBAMAZEPINE USP; CARIPRAZINE HYDROCHLORIDE; CELECOXIB USP; CHLORTHALIDONE USP; DAPAGLIFLOZIN AMORPHOUS.

API / Drug Master Files

AMOLI ORGANICS (A DIVISION OF UMEDICA LABORATORIES PVT LTD) holds 32 active (32 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.

• DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE USPActive2026-03-30
• ENZALUTAMIDEActive2026-02-24
• DESVENLAFAXINE USPActive2025-12-29
• SACUBITRIL SODIUMActive2025-11-14
• SITAGLIPTIN PHOSPHATE MONOHYDRATE USP PROCESS-IIActive2025-09-11
• DAPAGLIFLOZIN AMORPHOUS PROCESS-IIActive2025-08-30
• ROSUVASTATIN CALCIUM USP PROCESS-IIActive2025-07-29
• CARIPRAZINE HYDROCHLORIDEActive2025-04-24
• EMPAGLIFLOZINActive2024-12-23
• SACUBITRIL/VALSARTAN CRYSTALLINEActive2024-12-19
• DAPAGLIFLOZIN AMORPHOUSActive2024-07-30
• SACUBITRIL/VALSARTANActive2024-04-06
• APIXABANActive2023-09-23
• VARENICLINE TARTRATEActive2023-06-22
• RIVAROXABAN USPActive2023-03-04

Showing 15 of 32 Drug Master Files.

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to AMOLI ORGANICS (A DIVISION OF UMEDICA LABORATORIES PVT LTD) in our records. PharmaTek screens the full directory against live FDA enforcement data.