KOPRAN RESEARCH LABORATORIES LTD

Overview

KOPRAN RESEARCH LABORATORIES LTD is an active pharmaceutical ingredient (API) supplier with 6 active FDA Type II Drug Master Files, covering ATENOLOL USP; AZITHROMYCIN DIHYDRATE USP; METOPROLOL SUCCINATE USP; METOPROLOL TARTRATE USP; NITROXOLINE; PREGBALIN USP.

API / Drug Master Files

KOPRAN RESEARCH LABORATORIES LTD holds 6 active (8 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.

• NITROXOLINEActive2026-01-23
• METOPROLOL SUCCINATE USPActive2020-08-20
• METOPROLOL TARTRATE USPActive2020-05-30
• AZITHROMYCIN DIHYDRATE USPActive2020-05-21
• PREGBALIN USPActive2020-05-13
• ATENOLOL USPActive2018-07-27
• BIAPENEM STERILEInactive2020-06-16
• DORIPENEM STERILEInactive2020-06-16

FDA compliance signals

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