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.

Core services & business areas

API Manufacturing

Active pharmaceutical ingredients supplied

Substances AMOLI ORGANICS (A DIVISION OF UMEDICA LABORATORIES PVT 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

AMOLI ORGANICS (A DIVISION OF UMEDICA LABORATORIES PVT LTD) holds 33 active (33 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
  • EDOXABAN TOSYLATE MONOHYDRATEActive2025-07-29
  • 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

Showing 15 of 33 Drug Master Files.

FDA compliance signals

2 FDA enforcement records linked to this company.

  • 4832017-03-31

    Written sanitation procedures not followed

  • 4832017-03-31

    Storage under appropriate conditions

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