STERILE INDIA PVT LTD

Overview

STERILE INDIA PVT LTD is an active pharmaceutical ingredient (API) supplier with 11 active FDA Type II Drug Master Files, covering ACICLOVIR SODIUM (STERILE); AMPICILLIN SODIUM USP (STERILE); AZITHROMYCIN (LYOPHILIZED BULK STERILE); CEFTRIAXONE SODIUM USP (STERILE); CEFUROXIME SODIUM USP (STERILE); ESOMEPRAZOLE SODIUM (STERILE).

API / Drug Master Files

STERILE INDIA PVT LTD holds 11 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.

• AMPICILLIN SODIUM USP (STERILE)Active2018-05-04
• PIPERACILLIN & TAZOBACTAM SODIUM (STERILE)Active2016-11-28
• PANTOPRAZOLE SODIUM (STERILE)Active2016-11-28
• MEROPENEM FOR INJECTION USPActive2016-11-28
• AZITHROMYCIN (LYOPHILIZED BULK STERILE)Active2016-11-28
• CEFTRIAXONE SODIUM USP (STERILE)Active2016-11-28
• ACICLOVIR SODIUM (STERILE)Active2016-11-28
• CEFUROXIME SODIUM USP (STERILE)Active2016-11-28
• ESOMEPRAZOLE SODIUM (STERILE)Active2016-11-28
• RABEPRAZOLE SODIUM (STERILE)Active2016-11-28
• OMEPRAZOLE SODIUM (STERILE)Active2016-11-28

FDA compliance signals

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