GLAND PHARMA LTD

Overview

GLAND PHARMA LTD is an active pharmaceutical ingredient (API) supplier with 69 active FDA Type II Drug Master Files, covering ACETAZOLAMIDE; ARGATROBAN MONOHYDRATE (PROCESS-II); ARGATROBAN MONOHYDRATE USP; ARIPIPRAZOLE LAUROXIL – STERILE; ARIPIPRAZOLE MONOHYDRATE – STERILE; ATRACURIUM BESYLATE USP.

API / Drug Master Files

GLAND PHARMA LTD holds 69 active (69 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.

• PRALATREXATEActive2025-09-29
• ISAVUCONAZONIUM SULFATEActive2025-06-13
• DANTROLENE SODIUMActive2024-03-29
• LEVOCARNITINEActive2023-11-27
• FOSAPREPITANT DIMEGLUMINEActive2023-09-29
• EPINEPHRINE (LOW EPIMER)Active2023-09-27
• MANGANESE SULFATEActive2022-12-30
• CUPRIC SULFATEActive2022-12-23
• LINEZOLIDActive2022-11-30
• ACETAZOLAMIDEActive2022-10-31
• CYSTEAMINE HYDROCHLORIDEActive2022-08-30
• SELENIOUS ACIDActive2022-08-24
• CHLOROTHIAZIDEActive2022-06-30
• REGADENOSON (PROCESS – II)Active2022-06-24
• PROTAMINE SULFATEActive2021-12-29

Showing 15 of 69 Drug Master Files.

FDA compliance signals

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