ENALTEC LABS PRIVATE LTD

Overview

ENALTEC LABS PRIVATE LTD is an active pharmaceutical ingredient (API) supplier with 11 active FDA Type II Drug Master Files, covering CHLORPROMAZINE HYDROCHLORIDE USP; CLONIDINE HYDROCHLORIDE USP; DOFETILIDE USP; FLUPHENAZINE HYDROCHLORIDE USP; MIDODRINE HYDROCHLORIDE USP; NEOSTIGMINE METHYLSULFATE USP.

API / Drug Master Files

ENALTEC LABS PRIVATE LTD holds 11 active (15 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.

• FLUPHENAZINE HYDROCHLORIDE USPActive2019-08-30
• RAMELTEONActive2019-05-14
• PHYTONADIONE USPActive2018-08-31
• VARENICLINE TARTRATEActive2018-06-19
• DOFETILIDE USPActive2018-05-30
• CHLORPROMAZINE HYDROCHLORIDE USPActive2018-05-25
• NEOSTIGMINE METHYLSULFATE USPActive2018-03-05
• CLONIDINE HYDROCHLORIDE USPActive2017-08-28
• MIDODRINE HYDROCHLORIDE USPActive2016-09-27
• PHYTONADIONE USPActive2016-09-24
• TROSPIUM CHLORIDE USPActive2014-09-11
• FELBAMATE USPInactive2015-11-23
• CINACALCET HYDROCHLORIDEInactive2015-07-11
• ALCAFTADINEInactive2013-12-21
• DALFAMPRIDINEInactive2012-05-15

FDA compliance signals

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