OTSUKA CHEMICAL INDIA PRIVATE LTD

Overview

OTSUKA CHEMICAL INDIA PRIVATE LTD is an active pharmaceutical ingredient (API) supplier with 1 active FDA Type II Drug Master File, covering P-METHOXYBENZYL (6R,7R)-3-CHLOROMETHYL-8-OXO-7-PHENYLACETAMIDO-5-THIA-1-AZABICYCLO [4.2.0]OCT-2-ENE-2-CARBOXYLATE GCLE CHEMICAL SUBSTANCE.

API / Drug Master Files

OTSUKA CHEMICAL INDIA PRIVATE LTD 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.

• P-METHOXYBENZYL (6R,7R)-3-CHLOROMETHYL-8-OXO-7-PHENYLACETAMIDO-5-THIA-1-AZABICYCLO [4.2.0]OCT-2-ENE-2-CARBOXYLATE GCLE CHEMICAL SUBSTANCEActive2009-04-13

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to OTSUKA CHEMICAL INDIA PRIVATE LTD in our records. PharmaTek screens the full directory against live FDA enforcement data.