Merck KGaA

Overview

Merck Serono is the biopharmaceutical business of Merck KGaA, Darmstadt, Germany. It focuses on delivering high-quality medicines in the areas of oncology, neurology, immunology, and endocrinology. As a subsidiary, its mission aligns with the goals of its parent company, Merck KGaA.

Therapeutic areas

API / Drug Master Files

Merck KGaA holds 14 active (21 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.

• BENZONASE SALT TOLERANTActive2025-04-16
• BENZONASE SAFETY PLUSActive2023-08-28
• TRISODIUM CITRATE DIHYDRATEActive2015-12-07
• UREAActive2015-10-06
• SODIUM ACETATE TRIHYDRATEActive2010-05-13
• POTASSIUM IODIDEActive2010-03-09
• BORIC ACIDActive2009-09-08
• DIPOTASSIUM HYDROGEN PHOSPHATEActive2006-10-23
• CALCIUM CHLORIDE DIHYDRATEActive2005-07-01
• MAGNESIUM CHLORIDE HEXAHYDRATEActive2004-11-16
• SODIUM FLUORIDEActive1991-08-07
• BISOPROLOL FUMARATE 2:1Active1989-04-12
• PRAZIQUANTEL 2-(CYCLOHEXYLCARBONYL)-1,2,3,6,7,11BETA-4HPYRAZINO-(2,1-ALPHA)Active1981-10-02
• MEGLUMINEActive1978-10-17
• SODIUM ACETATE ANHYDROUSInactive2017-10-10

Showing 15 of 21 Drug Master Files.

FDA compliance signals

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