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.
Core services & business areas
Active pharmaceutical ingredients supplied
Substances GLAND PHARMA 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
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
31 FDA enforcement records linked to this company.
- 4832024-07-25
Record maintenance 1 year (except exempt OTC)
- 4832024-07-25
Procedures not in writing, fully followed
- 4832023-07-14
Complete test data included in records
- 4832019-11-07
Scientifically sound laboratory controls
- 4832019-11-07
Written record of investigation incomplete
- 4832019-11-07
Equipment for Environmental Control
- 4832019-11-07
Representative Samples
- 4832019-11-01
Written record of investigation incomplete
- 4832019-11-01
Validation lacking for sterile drug products
- 4832019-05-16
Written procedures lacking for use of pesticides etc.
- 4832019-05-16
Environmental Monitoring System
- 4832019-05-16
Cleaning SOPs/schedules
- 4832019-05-16
Scientifically sound laboratory controls
- 4832019-05-16
Written procedures fail to include
- 4832019-05-16
Written record of investigation incomplete
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