ALCHEM INTERNATIONAL LTD

Overview

ALCHEM INTERNATIONAL LTD is an active pharmaceutical ingredient (API) supplier with 8 active FDA Type II Drug Master Files, covering 10 DEACETYL BACCATIN III (10 DAB III); ATROPINE SULFATE USP; COLCHICINE EXTRA PURE GRADE; DIGOXIN USP; HYOSCINE EP (SCOPOLAMINE); METHSCOPOLAMINE BROMIDE USP.

API / Drug Master Files

ALCHEM INTERNATIONAL LTD holds 8 active (10 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.

• NICOTINE USP (4691A)Active2023-05-18
• ATROPINE SULFATE USPActive2016-12-20
• DIGOXIN USPActive2016-07-06
• SCOPOLAMINE HYDROBROMIDE USPActive2016-07-06
• HYOSCINE EP (SCOPOLAMINE)Active2016-07-06
• METHSCOPOLAMINE BROMIDE USPActive2015-09-24
• COLCHICINE EXTRA PURE GRADEActive2009-02-18
• 10 DEACETYL BACCATIN III (10 DAB III)Active2006-03-14
• DIGOXIN USPInactive2013-09-30
• COLCHICINE USPInactive2003-12-01

FDA compliance signals

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