SPECIALTY GenericS

generic-api-molecules 
Transform the Ordinary into Extraordinary. 

Alcami is a global leader in the Specialty Generic API space and offers a variety of services at our Center of Excellence for API development and manufacturing in Germantown, Wisconsin, including the following: 

Off the Shelf Generic APIs Generic APIs in Development
Anagrelide  Alfentanil
Bromfenac  Buprenorphine
Dexmedetomidine HCI Midazolam
Dexrazoxane   
Fomepizole  
Isradipine   
Pilocarpine  
 
Process Development and Custom Synthesis 
  • Multiple approaches to development of new generic APIs 
    • Joint ventures, fee for service, royalty agreements, and additional support services  
    • Shared IP, customer owns IP, Alcami owns IP
  • Support qualification and commercial needs from grams to metric ton quantities 
  • Develop new, non-patent infringing processes for drugs nearing patent expiration 
Highly Potent Generic APIs
  • Small molecule chemistry from gram to 10kg batch size
  • Glass and Hastelloy® C-22 PLC-controlled reactors up to 100L 
  • Distillation, cryogenic, and hydrogenation capabilities 
  • Aurora® filter isolation, drying, and packaging 
  • Versatile, enclosed processing space for expanded portable capabilities 

Take a Virtual Tour of our Germantown, WI Facility

DEA Controlled Generic APIs
  • DEA registration for Schedules I-V in our R&D assets 
  • DEA registration for Schedules II-V in our manufacturing assets 
Strong Quality and Regulatory History 
  • Over 15-year history of Specialty Generic API manufacturing 
  • FDA audited/inspected facility located approximately 90 miles north of Chicago 
  • Worldwide distribution and regulatory support for multiple markets 

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US-based Manufacturing Sites
  • Strong IP protection 
  • Reliable and auditable manufacturing sites 
  • Exemplary regulatory track record
Integration into Alcami's End-to-End Service Offering
  • Seamlessly integrates into Alcami's Drug Product (oral solid/parenteral) and Packaging services; from API development and manufacturing to packaged and serialized Drug Product
  • This leads to shorter lead times from purchase order placement to delivery 
Strong Global Supply Chain
  • Experience shipping products worldwide, including temperature controlled and monitored shipments
  • Inventory management or "Just in Time" manufacture and delivery 

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