JANSSEN RESEARCH AND DEVELOPMENT LLC

Overview

JANSSEN RESEARCH AND DEVELOPMENT LLC is an active pharmaceutical ingredient (API) supplier with 3 active FDA Type II Drug Master Files, covering METHYLPHENIDATE HYDROCHLORIDE DRUG SUBSTANCE (PROCESS I); METHYLPHENIDATE HYDROCHLORIDE DRUG SUBSTANCE (PROCESS II); RILPIVIRINE EXTENDED RELEASE SUSPENSION FOR INJECTION.

API / Drug Master Files

JANSSEN RESEARCH AND DEVELOPMENT LLC holds 3 active (3 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.

• METHYLPHENIDATE HYDROCHLORIDE DRUG SUBSTANCE (PROCESS II)Active2021-07-30
• RILPIVIRINE EXTENDED RELEASE SUSPENSION FOR INJECTIONActive2019-04-22
• METHYLPHENIDATE HYDROCHLORIDE DRUG SUBSTANCE (PROCESS I)Active2016-05-25

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to JANSSEN RESEARCH AND DEVELOPMENT LLC in our records. PharmaTek screens the full directory against live FDA enforcement data.