One Standard of Excellence.
Athenex is a growing, global pharmaceutical company that develops and delivers products in four distinct disciplines.
From our 503B outsourced compounding pharmacy services and sterile injectable pharmaceutical products to our active pharmaceutical ingredients and novel oncolytics businesses, we’re strongly focused on providing one standard of quality—and one standard of excellence—to every customer we serve.
Our stringent processes, rigorous testing and quality controls are objective, measurable and repeatable—and at the heart of everything we do.
At Athenex, we take these extra steps to advance the objectives we share with our customers: products and processes that can help enhance patient safety.
The FDA Has New Requirements. Meet Your New Standard.
The new product quality, testing and safety regulations issued and enforced by the U.S. Food & Drug Administration (FDA) are fantastic news for hospital
If you’re not familiar with the legislation, it states that all 503B suppliers(outsourced compounding pharmacy providers) MUST comply with current good manufacturing practice (cGMP) requirements.
Click here for more detail from FDA.
“cGMPs provide for systems that assure proper design, monitoring, and control of manufacturing
processes and facilities. Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards.”
This is a great advancement for hospitals because now your outsourced compounded products are required to be produced meeting the same quality standards as commercially available finished drug products.
At Athenex, we’re delighted. This is precisely how we’re set up to serve you.
Unlike most “legacy compounders”, Athenex has built and is continuing to build our 503B operations specifically aligned with cGMP standards.
That means when you choose Athenex you know that sterility and finished product release testing will be done on EVERY BATCH. Moreover, we’ll provide a Certificate of Analysis (C of A) for your records to demonstrate your products are within prescribed quality, testing and safety parameters.
Ask your Athenex sales representative about our growing product portfolio, currently available products and pricing.
Sterile Injectables. Our Supply for Your Demand.
In addition to providing, sterile, small batch production in a cGMP outsourcing facility to serve our 503B customers, Athenex also offers FDA-approved, finished-dose sterile injectable products in a wide array of formulations and presentations. Sourced through long-standing relationships with trusted sterile injectable manufacturers—Athenex is helping customers to address both their most frequently-used products as well as those products often found in short supply.
Ask your Athenex sales representative about the breadth of our products and ways you can order.
Active Pharmaceutical Ingredients. The Key Word is Active.
Another way Athenex stands out is our active and ongoing pursuit to make pharmaceutical products more affordable and more readily available for customers. Experience has demonstrated that the critical component in achieving a steady product supply often can be the availability of the API (Active Pharmaceutical Ingredient) needed to make the products.
By acquiring and developing API that can be used internally or sold to other companies, Athenex is striving to reduce the volatility of market supply and improve the reliability of the supply chain.
Ask your Athenex sales representative about how Athenex’s API business could be indirectly adding value to the efficiency and consistency of your pharmacy operations.
Consider Athenex’s API to help drive supply reliability.
Striving to Improve the Lives of Cancer Patients Everywhere.
Athenex is pursuing new and ground-breaking avenues around the world to help improve patient delivery mechanisms for oncology and has several new and proprietary compounds currently in late-stage clinical trials.
From oral absorption platforms for high-potency oncology medications that are currently only available via infusion to novel topical treatments for certain types of skin cancer, Athenex is helping to usher in the next generation of innovation in oncology care. Our mission is both simple and far-reaching: to help improve the lives of cancer patients everywhere.
Click here to see how Athenex’s Novel Oncoloytics platforms are striving to change the face of oncology.
Empire State-of-the-Art. With a Capital A.
Working in conjunction with the State of New York, Athenex is building a 300,000-square foot, state-of-the-art, cGMP manufacturing facility just outside of Buffalo in Dunkirk, NY. This world-class production center reflects Athenex’s profound and ongoing commitment to delivering the highest standards of pharmaceutical product quality and patient safety anywhere in the world. Athenex’s investment in the project totals over $1.62 billion with the State of New York contributing an additional $225 million.
Global Strength. Local Feel.
The quality of our products, the efficiency of our production processes and the responsiveness of our local teams are made possible by a deep reservoir of global resources and exceptional pharmaceutical expertise. Athenex currently has research, development, manufacturing, distribution, materials sourcing, commercialization and/or clinical trial operations thriving on five continents around the world.
Login to the Athenex Customer Portal
For the convenience of our Athenex customers, we offer an easy-to-use customer portal as the digital access point for ordering Athenex products.
If you are a current customer, simply click on the shopping cart icon below to begin. If you’d like to become a customer, please click or call—
we’d love to serve you!
Our proprietary, differentiated and highly-visible label designs can assist pharmacists in accurate medication selection.
Pharmacists and pharmaceutical companies agree: there is no greater priority than patient safety. At Athenex, to help promote accurate medication selection, we’re focusing our patient safety efforts precisely where pharmacists’ eyes will be—on every drug label and package. With a unique AccuraSEE label design for every Athenex product, we’re helping your pharmacy to reduce the risk of medication errors. The idea is simple:
“So what you see is exactly what you get.”
Choose Athenex AccuraSEE for your pharmacy.
The Latest News from Athenex
Keep apprised of the latest exciting developments happening across our company—from new products, partnerships and personnel to our expanding operations around the world—at Athenex News.
Click here to contact us