SARACA LABORATORIES LTD

Overview

SARACA LABORATORIES LTD is an active pharmaceutical ingredient (API) supplier with 1 active FDA Type II Drug Master File, covering GABAPENTIN USP.

API / Drug Master Files

SARACA LABORATORIES LTD holds 1 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.

• GABAPENTIN USPActive2017-07-13
• RANITIDINE HCI (FORM-I)Inactive2006-11-08
• RANITIDINE HYDROCHLORIDE (FORM-II)Inactive2004-09-22

FDA compliance signals

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