SOUTHWEST SYNTHETIC PHARMACEUTICAL CORP LTD

Overview

SOUTHWEST SYNTHETIC PHARMACEUTICAL CORP LTD is an active pharmaceutical ingredient (API) supplier with 5 active FDA Type II Drug Master Files, covering MECLIZINE HYDROCHLORIDE; NABUMETONE USP; SIMVASTATIN USP; SULFAMETHOXAZOLE USP; TRIMETHOPRIM USP.

API / Drug Master Files

SOUTHWEST SYNTHETIC PHARMACEUTICAL CORP LTD holds 5 active (8 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.

• SIMVASTATIN USPActive2009-12-29
• MECLIZINE HYDROCHLORIDEActive2006-04-28
• NABUMETONE USPActive2005-06-24
• TRIMETHOPRIM USPActive1987-01-20
• SULFAMETHOXAZOLE USPActive1987-01-20
• SIMVASTATIN AMMONIUM SALTInactive2011-04-29
• SULFADIAZINEInactive2009-04-02
• KETOPROFEN USP XXIIInactive1990-02-01

FDA compliance signals

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