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].

Core services & business areas

Active pharmaceutical ingredients supplied

Substances AMOLI ORGANICS PRIVATE 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 PRIVATE LTD holds 4 active (4 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.

• SERTRALINE HYDROCHLORIDE USPActive2021-10-15
• DIMETHYL FUMARATEActive2019-09-05
• RANOLAZINEActive2018-07-30
• DICLOFENAC POTASSIUM USPActive2009-08-12

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.