INDOCO REMEDIES LTD
Overview
INDOCO REMEDIES LTD is an active pharmaceutical ingredient (API) supplier with 21 active FDA Type II Drug Master Files, covering ALLOPURINOL USP; ALOGLIPTIN BENZOATE; APIXABAN; ARIPIPRAZOLE USP; BESIFLOXACIN HYDROCHLORIDE; BETAXOLOL HYDROCHLORIDE USP.
Core services & business areas
Active pharmaceutical ingredients supplied
Substances INDOCO REMEDIES 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
INDOCO REMEDIES LTD holds 21 active (24 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.
- RIVAROXABAN USPActive2022-11-10
- LACOSAMIDE USP (PROCESS II)Active2022-03-17
- METOPROLOL SUCCINATE USPActive2020-09-24
- ARIPIPRAZOLE USPActive2019-07-03
- NEOSTIGMINE METHYLSULFATE USPActive2016-11-30
- CANAGLIFLOZINActive2016-10-18
- APIXABANActive2016-07-20
- ALOGLIPTIN BENZOATEActive2016-06-30
- LACOSAMIDE USPActive2015-07-10
- BESIFLOXACIN HYDROCHLORIDEActive2015-07-07
- FEBUXOSTAT HEMIHYDRATE (FORM G)Active2015-02-11
- BRINZOLAMIDE USPActive2014-04-02
- RASAGILINE MESYLATEActive2013-11-12
- BETAXOLOL HYDROCHLORIDE USPActive2011-09-22
- BROMFENAC SODIUMActive2011-08-18
Showing 15 of 24 Drug Master Files.
FDA compliance signals
8 FDA enforcement records linked to this company.
- warning_letter2024-12-16
FDA Warning Letter (drug product)
- 4832023-02-28
Scientifically sound laboratory controls
- 4832023-02-28
Procedures for sterile drug products
- 4832023-02-28
Environmental Monitoring System
- 4832023-02-28
Equipment to control conditions
- 4832018-11-21
Complaint Handling Procedure
- 4832018-11-21
Procedures not in writing, fully followed
- warning_letter2017-03-31
FDA Warning Letter (drug product)
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