PARTICLE DYNAMICS INTERNATIONAL LLC

Overview

PARTICLE DYNAMICS INTERNATIONAL LLC is an active pharmaceutical ingredient (API) supplier with 3 active FDA Type II Drug Master Files, covering DESTAB(TM) CALCIUM CARBONATE 95S ULTRA 250; DESTAB™ LACTITOL; MICROMASK® IBUPROFEN 72%.

API / Drug Master Files

PARTICLE DYNAMICS INTERNATIONAL LLC holds 3 active (4 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.

• DESTAB™ LACTITOLActive2017-09-18
• DESTAB(TM) CALCIUM CARBONATE 95S ULTRA 250Active2004-08-18
• MICROMASK® IBUPROFEN 72%Active1999-08-06
• DESTAB CALCIUM CARBONATE 95%Inactive1992-11-20

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to PARTICLE DYNAMICS INTERNATIONAL LLC in our records. PharmaTek screens the full directory against live FDA enforcement data.