STYRAX PHARMA PRIVATE LTD

Overview

STYRAX PHARMA PRIVATE LTD is an active pharmaceutical ingredient (API) supplier with 3 active FDA Type II Drug Master Files, covering 4-AMINO-2-OXO-PYRIMIDINYL-OXATHIOLANE-2-CARBOXILIC ACID-ISOPROPYL-METHYL CYCLOHEXYLESTER (CHE-II); DOLUTEGRAVIR SODIUM; TENOFOVIR DISOPROXIL FUMARATE.

API / Drug Master Files

STYRAX PHARMA PRIVATE LTD 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.

• DOLUTEGRAVIR SODIUMActive2022-02-13
• TENOFOVIR DISOPROXIL FUMARATEActive2021-05-21
• 4-AMINO-2-OXO-PYRIMIDINYL-OXATHIOLANE-2-CARBOXILIC ACID-ISOPROPYL-METHYL CYCLOHEXYLESTER (CHE-II)Active2020-01-02

FDA compliance signals

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