Active Pharmaceutical Ingredients and Excipients

Purolite 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. The generic market in the US alone will approach $200 billion by 2024 and is having a positive impact on lowering the cost of health care. Our resins are used in drug formulations as active pharmaceutical ingredients (APIs) or excipients.

The production of all pharmaceutical products must adhere to strict guidelines. Purolite 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 Purolite’s facilities. We provide support to allow rapid filing and approval by the FDA.

Active Pharmaceutical Ingredients
Purolite 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. Purolite 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
Purolite excipients can be used in drug formulations as taste-masking agents, drug carriers and tablet disintegrants. The excipients are often used in off-patented products as well as for new formulations.