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).

Core services & business areas

Active pharmaceutical ingredients supplied

Substances STERILE INDIA PVT LTD is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.

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