NEWGEN BIOTECH INC

Farmers Branch, Texas, United States newgenbiotech.com

Overview

NEWGEN BIOTECH INC is an active pharmaceutical ingredient (API) supplier with 3 active FDA Type II Drug Master Files, covering ALPHA GALACTOSIDASE; BETA 1, 3/1, 6 GLUCAN; LACTASE USP.

API / Drug Master Files

NEWGEN BIOTECH INC holds 3 active (5 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.

  • BETA 1, 3/1, 6 GLUCANActive2016-11-10
  • ALPHA GALACTOSIDASEActive2016-11-10
  • LACTASE USPActive2016-08-22
  • SERRAPEPTASEInactive2013-05-06
  • BROMELAINInactive2013-05-06

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to NEWGEN BIOTECH INC in our records. PharmaTek screens the full directory against live FDA enforcement data.

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