S A PHARMACHEM PVT LTD

Overview

S A PHARMACHEM PVT LTD is an active pharmaceutical ingredient (API) supplier with 13 active FDA Type II Drug Master Files, covering CALCIUM ACETATE; CALCIUM CITRATE; CALCIUM GLUCONATE IP/BP/EP/USP; CALCIUM LACTATE PENTAHYDRATE BP/EP/USP; MAGNESIUM CARBONATE (HEAVY); MAGNESIUM CARBONATE LIGHT.

API / Drug Master Files

S A PHARMACHEM PVT LTD holds 13 active (14 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.

• POTASSIUM ACETATE BP/EP/USPActive2021-06-12
• ZINC GLUCONATE BP/EP/USPActive2021-06-12
• ZINC CITRATE USPActive2021-05-27
• CALCIUM LACTATE PENTAHYDRATE BP/EP/USPActive2021-05-27
• CALCIUM GLUCONATE IP/BP/EP/USPActive2021-05-27
• CALCIUM ACETATEActive2009-02-19
• CALCIUM CITRATEActive2009-02-19
• SODIUM CITRATEActive2009-02-19
• MAGNESIUM CARBONATE LIGHTActive2009-02-18
• MAGNESIUM OXIDE LIGHTActive2009-02-16
• MAGNESIUM CARBONATE (HEAVY)Active2009-01-20
• MAGNESIUM OXIDE (HEAVY)Active2009-01-20
• PREGELATINIZED STARCH BP/USPActive2007-09-21
• MAGNESIUM HYDROXIDEInactive2009-02-19

FDA compliance signals

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