SWATI SPENTOSE PRIVATE LTD

Overview

SWATI SPENTOSE PRIVATE LTD is an active pharmaceutical ingredient (API) supplier with 12 active FDA Type II Drug Master Files, covering GLYCOPYRROLATE USP; GRANISETRON HYDROCHLORIDE USP; LIDOCAINE HYDROCHLORIDE USP; LIDOCAINE USP; MELATONIN USP; MELOXICAM.

API / Drug Master Files

SWATI SPENTOSE PRIVATE LTD holds 12 active (12 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.

• MIRABEGRONActive2026-03-17
• GLYCOPYRROLATE USPActive2023-09-06
• SILODOSINActive2023-03-01
• TAMSULOSIN HYDROCHLORIDE USPActive2022-03-30
• PRILOCAINE HYDROCHLORIDE USPActive2021-01-30
• PRILOCAINE USPActive2020-10-31
• GRANISETRON HYDROCHLORIDE USPActive2020-08-27
• MELATONIN USPActive2020-08-08
• LIDOCAINE HYDROCHLORIDE USPActive2012-03-06
• LIDOCAINE USPActive2012-02-22
• PENTOSAN POLYSULFATE SODIUMActive2012-02-22
• MELOXICAMActive2005-09-30

FDA compliance signals

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