Active Pharmaceutical Ingredients (APIs) and Excipients

Ecolab has been manufacturing and selling to the generic pharmaceutical market for over three decades.

Generics are off-patent drugs that are bioequivalent to branded medications in terms of dosage, strength, quality, form, effect, intended use, side effects, and route of administration. Our resins are used in drug formulations such as APIs or excipients. 

The production of all pharmaceutical products must adhere to strict guidelines. Ecolab pharmaceutical resins meet the demands of the American (USP), European (Ph.Eur.), British (BP) and Japanese (JP) pharmacopeias. Drug Master Files (DMFs) are held for each, single, listed API pharmaceutical product manufactured in Ecolab’s facilities. We provide support to allow rapid filing and approval by the FDA. 

Active Pharmaceutical Ingredients
Ecolab markets two APIs with registered DMFs to large pharmaceutical companies: Cholestyramine and Sodium Polystyrene Sulfonate.  

Cholestyramine is taken orally to reduce blood cholesterol, while sodium polystyrene sulfonate, is taken to control blood potassium to prevent hypokalemia.  

Ecolab provides value to these mature markets in many ways including the stability of supply. We continue to invest in the expansion and maintenance of four cleanroom operations as well as analytical and quality-related systems. 

Excipients
Ecolab excipients can be used in drug formulations as the following:

• Taste Masking 
• Tablet Disintegration 
• Modified Release 
• Drug Stability 
• Solubility Enhancement 
• Abuse Deterrence