HIKAL LTD

Overview

HIKAL LTD is an active pharmaceutical ingredient (API) supplier with 34 active FDA Type II Drug Master Files, covering APIXABAN; BUPROPION HYDROBROMIDE (FORM II); BUPROPION HYDROBROMIDE (FORM-I); BUPROPION HYDROCHLORIDE USP; BUPROPION HYDROCHLORIDE USP [PROCESS-2]; BUTORPHANOL TARTRATE USP.

API / Drug Master Files

HIKAL LTD holds 34 active (40 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.

• VONOPRAZAN FUMARATEActive2026-03-31
• CARIPRAZINE HYDROCHLORIDEActive2026-03-30
• EDOXABAN TOSYLATE MONOHYDRATEActive2024-09-30
• DABIGATRAN ETEXILATE MESILATEActive2024-06-29
• RIVAROXABAN USPActive2023-08-18
• BUPROPION HYDROBROMIDE (FORM II)Active2023-05-29
• BUPROPION HYDROBROMIDE (FORM-I)Active2023-03-24
• DESVENLAFAXINE SUCCINATE USPActive2022-08-20
• SITAGLIPTIN HYDROCHLORIDE (PROCESS B)Active2022-06-30
• ERTUGLIFLOZIN L-PYROGLUTAMIC ACIDActive2020-05-01
• SITAGLIPTIN PHOSPHATE ANHYDRATEActive2020-03-28
• EMPAGLIFLOZINActive2018-09-12
• DAPAGLIFLOZIN (DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE)Active2018-04-30
• APIXABANActive2017-12-29
• CELECOXIBActive2017-07-29

Showing 15 of 40 Drug Master Files.

FDA compliance signals

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