SHODHANA LABORATORIES LTD

Overview

SHODHANA LABORATORIES LTD is an active pharmaceutical ingredient (API) supplier with 5 active FDA Type II Drug Master Files, covering CARVEDILOL [USP]; CYANODIOL HEMI DPTTA SALT; DULOXETINE HYDROCHLORIDE [USP]; ESCITALOPRAM OXALATE; RIVASTIGMINE.

API / Drug Master Files

SHODHANA LABORATORIES LTD holds 5 active (6 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.

• RIVASTIGMINEActive2024-10-05
• DULOXETINE HYDROCHLORIDE [USP]Active2024-07-15
• CARVEDILOL [USP]Active2024-05-14
• ESCITALOPRAM OXALATEActive2023-12-18
• CYANODIOL HEMI DPTTA SALTActive2018-02-21
• DULOXETINE HYDROCHLORIDE USPInactive2014-06-17

FDA compliance signals

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