COVALENT LABORATORIES PRIVATE LTD

Overview

COVALENT LABORATORIES PRIVATE LTD is an active pharmaceutical ingredient (API) supplier with 9 active FDA Type II Drug Master Files, covering 7-AMINO-3-VINYL-3-CEPHEM-4-CARBOXYLIC ACID (7-AVNA); CEFDINIR HYDRATE USP; CEFDINIR USP; CEFIXIME USP; CEFPODOXIME PROXETIL USP; CEFPROZIL USP.

API / Drug Master Files

COVALENT LABORATORIES PRIVATE LTD holds 9 active (11 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.

• CEFDINIR HYDRATE USPActive2016-02-22
• CEFPODOXIME PROXETIL USPActive2015-09-14
• CEFPROZIL USPActive2015-05-15
• CEFIXIME USPActive2013-04-29
• CEFDINIR USPActive2012-03-19
• CEFUROXIME AXETIL USP (AMORPHOUS)Active2011-06-24
• CEFUROXIME ACID (ACETONE ROUTE)Active2010-12-28
• 7-AMINO-3-VINYL-3-CEPHEM-4-CARBOXYLIC ACID (7-AVNA)Active2009-11-23
• MECLIZINE HYDROCHLORIDE USPActive2009-07-08
• CEFUROXIME AXETIL USP (CRYSTALLINE)Inactive2009-10-23
• CEFUROXIME ACIDInactive2008-07-09

FDA compliance signals

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