cGMP

cGMP outsourcing is one of the most effective ways to reduce "time to market," optimize your cost structure and streamline your operations. With more of your resources devoted to core pharmaceutical activities, your assets become more productive, and so does your marketing effort.

Quality intermediates and support from Albemarle let you focus more of your resources on drug discovery and marketing, and less on costly manufacturing facilities.

That’s why we’ve invested heavily in pharmaceutical ingredient manufacturing technology: so that you can maximize your return on clinical work at the front end, and on successful new product introductions at the back end.

Our commitment to the pharmaceutical industry is easy to see: Our bulk-active ibuprofen plant is the world’s largest. We feature a cGMP kilo lab and cGMP pilot plant at our Dayton, Ohio, facility. We produce millions of kilograms under cGMP every year. We recently invested $7 million in our flexible commercial scale manufacturing facility in Orangeburg, South Carolina.

The new cGMP unit includes several features to help make your products quickly and effectively:

• flexible reactors in sizes from 1,000 to 16,000 gal
• a wide variety of construction materials, for example, GL, SS, Alloy 20, Hastelloy, Nickel, Inconel
• multiple solids isolation and drying capabilities
• a 50-stage cGMP distillation column and a separate liquids packaging room
• a cGMP hydrogenation unit for corrosive reaction conditions and pressures up to 100 psig
• a pilot plant with 50- to 500-gal reactors, solids separation and drying, and fine chemical production
• expert, experienced R&D and technical operations staff
• a full complement of analytical capabilities and equipment.

When coupled with our significant regulatory and DMF experience, and excellent US FDA track record in Orangeburg (only one minor 483 in more than 25 years of API production), we think that our expansion offers you a unique set of benefits.

As a result, our robust project pipeline has already begun filling with new cGMP business, and we expect this new business—like our renowned heritage in bromine fine chemicals—to provide a base for future fine chemistry services growth.

Let our experts help you with your own unique cGMP project. Ask us about your product today.