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.
Core services & business areas
Active pharmaceutical ingredients supplied
Substances KOPRAN RESEARCH LABORATORIES 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
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
- DORIPENEM STERILEInactive2020-06-16
- BIAPENEM 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.
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