OPTIMUS DRUGS PRIVATE LTD

Overview

OPTIMUS DRUGS PRIVATE LTD is an active pharmaceutical ingredient (API) supplier with 53 active FDA Type II Drug Master Files, covering (1R)-2-[(2-(4-NITROPHENYL) ETHYL] AMINO] -1- PHENYL ETHANOL. HCL (MIRABEGRON INTERMEDIATE); (2S)-2-[(METHOXYCARBONYL)AMINO]-3,3-DIMETHYLBUTANOIC ACID [ATAZANAVIR INTERMEDIATE]; (R) -ALPHA-[[[2-(4-NITRO-PHENYL)-ETHYL]AMINO]METHYL]BENZENE METHANOL(MIRABEGRON INTERMEDIATE); (R)-5-BROMO-3-[(1-METHYL-2-PYRROLIDINYL)METHYL]-1H-INDOLE (ELETRIPTAN INTERMEDIATE); (S)-1-PHENYL-1,2,3,4-TETRAHYDRO-2-ISOQUINOLINE (SOLIFENACIN INTERMEDIATE); 17-IODO-ANDROSTA-5,16-DIENE-3BETA-OL (ABIRATERONE INTERMEDIATE).

API / Drug Master Files

OPTIMUS DRUGS PRIVATE LTD holds 53 active (56 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.

• EDOXABAN TOSYLATE MONOHYDRATEActive2025-03-29
• CENOBAMATEActive2025-03-28
• FINERENONEActive2025-03-26
• TAPINAROF (FORM 1)Active2025-03-22
• CARIPRAZINE HYDROCHLORIDEActive2025-02-14
• LINEZOLID USP (FORM-III)Active2024-12-31
• CRISABOROLEActive2024-03-28
• ELAGOLIX SODIUMActive2024-03-28
• ISAVUCONAZONIUM SULFATEActive2024-03-28
• EMPAGLIFLOZINActive2024-03-28
• VILDAGLIPTINActive2024-01-23
• ELTROMBOPAG OLAMINEActive2023-11-01
• UPADACITINIB HEMIHYDRATEActive2023-02-09
• TAFAMIDIS MEGLUMINEActive2022-08-16
• NIRMATRELVIRActive2022-07-29

Showing 15 of 56 Drug Master Files.

FDA compliance signals

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