RL FINE CHEM PVT LTD

Overview

RL FINE CHEM PVT LTD is an active pharmaceutical ingredient (API) supplier with 27 active FDA Type II Drug Master Files, covering ALPRAZOLAM; AMITRIPTYLINE HYDROCHLORIDE; BUSPIRONE HYDROCHLORIDE; CARBINOXAMINE MALEATE; CHLORDIAZEPOXIDE; CHLORPROMAZINE HYDROCHLORIDE.

API / Drug Master Files

RL FINE CHEM PVT LTD holds 27 active (27 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.

• PRAMOXINE HYDROCHLORIDEActive2025-11-27
• ESZOPICLONEActive2025-04-01
• SERTRALINE HYDROCHLORIDE FORM IIActive2024-10-30
• BUSPIRONE HYDROCHLORIDEActive2024-10-18
• SERTRALINE HYDROCHLORIDE FORM IActive2024-09-26
• OXAZEPAMActive2024-08-28
• TEMAZEPAMActive2023-10-06
• ORPHENADRINE CITRATEActive2023-06-05
• CLOZAPINEActive2023-03-09
• CLONAZEPAMActive2023-02-22
• MECLIZINE HYDROCHLORIDEActive2022-07-30
• DOXEPIN HYDROCHLORIDEActive2020-01-20
• CARBINOXAMINE MALEATEActive2019-08-30
• CHLORDIAZEPOXIDEActive2019-06-26
• DIAZEPAMActive2019-06-07

Showing 15 of 27 Drug Master Files.

FDA compliance signals

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