KOTHARI PHYTOCHEMICALS INTERNATIONAL

Overview

KOTHARI PHYTOCHEMICALS INTERNATIONAL is an active pharmaceutical ingredient (API) supplier with 4 active FDA Type II Drug Master Files, covering CHLORPROPAMIDE USP; METFORMIN HYDROCHLORIDE USP; SENNOSIDES USP; TOLBUTAMIDE USP.

API / Drug Master Files

KOTHARI PHYTOCHEMICALS INTERNATIONAL holds 4 active (6 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.

• SENNOSIDES USPActive2018-01-29
• METFORMIN HYDROCHLORIDE USPActive2011-11-24
• TOLBUTAMIDE USPActive2011-07-01
• CHLORPROPAMIDE USPActive2011-05-11
• CHLORPROPAMIDE AND TOLBUTAMIDEInactive1986-01-21
• PROPRANOLOL HYDROCHLORIDEInactive1985-05-31

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to KOTHARI PHYTOCHEMICALS INTERNATIONAL in our records. PharmaTek screens the full directory against live FDA enforcement data.