GRANULES INDIA LTD (UNIT-V)

Overview

GRANULES INDIA LTD (UNIT-V) is an active pharmaceutical ingredient (API) supplier with 1 active FDA Type II Drug Master File, covering NILOTINIB HYDROCHLORIDE MONOHYDRATE.

API / Drug Master Files

GRANULES INDIA LTD (UNIT-V) holds 1 active (1 total) FDA Type II Drug Master File — 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.

• NILOTINIB HYDROCHLORIDE MONOHYDRATEActive2022-09-30

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to GRANULES INDIA LTD (UNIT-V) in our records. PharmaTek screens the full directory against live FDA enforcement data.