Alcami

Alcami is a world-class contract development and manufacturing organization (CDMO) with executive offices in Wilmington and Durham, North Carolina. Alcami is the first company to offer a solution that is tailored to small and mid-size pharmaceutical and biotechnology companies, offering a range of services from four distinct pillars. Beyond that, we can integrate our services so customers experience a simplified engagement with a single project management relationship, full visibility from development into manufacturing,and shorter turnaround times. With over 1,000 employees operating at ten global locations, our combined capabilities include:

  • API development and manufacturing

  • Solid state chemistry

  • Formulation development

  • Analytical development and testing services

  • Clinical and commercial finished dosage form manufacturing (oral solid dose and parenteral)

  • Packaging and stability services

Alcami offers an end-to-end outsourcing opportunity that can be integrated for a less fragmented,cost-effective, and faster pathway for products through the clinic toward commercialization, as well as individualized development and manufacturing services. 

It is our goal to bethe most efficient, safe and reliable option to bring your product to market.

We make it easy for our partners to bring their products through the clinic to commercialization,embracing an approach that integrates our operations in a unique and highly effective way and where a product’s potential is turned into reality day-after-day. With a flexible and responsive approach, our Project and Program Management group will help ensure the focus is always on the best possible outcome for your product at every level.

Alcami meets all applicable local, state and federal regulatory requirements, including current GMPs and country guidelines for the U.S., Canada, EU and EU Member State regulatory bodies (e.g., EMA, MPA, IMB). We also incorporate international standards as part of the Quality Management System and meet expectations established by the USP, EP and JP. We comply with all regulations and standards, including those regarding controlled substances (DEA), radio active materials (NRC), environmental protection (EPA), child-resistant container-closures (CPSC) and employee safety (OSHA). 

Alcami offers all phases of pharmaceutical drug product development for small and large molecules through two laboratories located in Durham and Wilmington, North Carolina.These facilities have supported more than 500 investigational New Drug (IND) filings and over 50 NDAs, ANDAs and NADAs since 1985.Two cGMP API facilities in Germantown, Wisconsin and Weert, Netherlands support Alcami’s process development / scale-up and clinical and commercial supply of APIs for customers worldwide. The Weert facility also serves as the company’s Center of Excellence for Solid State Chemistry. Regional cGMP analytical laboratories in St. Louis,Missouri, Wilmington, North Carolina and Edison, New Jersey provide comprehensive analytical testing solutions for Alcami customers’ new drug entities and biopharmaceuticals, as well as generic drugs, chemicals and animal health, and medicated consumer health products. Alcami’s cGMP drug product manufacturing facilities support clinical and commercial supply. Our Charleston, South Carolina facility is focused on processing parenteral products while the Wilmington, North Carolina facility is dedicated to solid oral dose manufacture. Both are fully integrated with Alcami’s packaging and distribution center.

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Locations


United States
Solid Dose Manufacturing Services
1726 N. 23rd St.
Wilmington, NC  28405
United States, North America
United States
Sterile Manufacturing Services
4221 Faber Place Drive
Charleston, SC  29405
United States, North America
United States
Development Services & Analytical Testing
2320 Scientific Park Drive
Wilmington, NC  28405
United States, North America
United States
Packaging and Labeling
1519 N. 23rd Street
Wilmington, NC  28405
United States, North America
United States
Alcami Global Headquarters
4620 Creekstone Drive
Suite 200
Durham, NC  27703
United States, North America
United States
Analytical Testing
165 Fieldcrest Avenue
Edison, NJ  08837
United States, North America
United States
Analytical Testing
4260 Forest Park Avenue
Suite 201
St. Louis, MO  63108
United States, North America
United States
Sm Molecule API Development & Manufacturing
W132 N 10550 Grant Dr.
Germantown, WI  53022
United States, North America
Netherlands
Sm Molecule API Development & Manufacturing
Vliesvenweg 1
6002NM Weert,
Netherlands, Europe

Contacts


Marketing Communications
Sales & Business Development
General Inquires

Production Lines

Sterile Manufacturing Services   Alcami Pre-Clinical - Commercial Liquid Fill Finis
Location: Charleston, SC, United States
Main Details
Specialization:  Drug Product (Fill/Finish)Drug Product (Fill/Finish)
Dosage Form:  LiquidLiquid
Batch Size:  50,000+50,000+
Supported Vial Size:  2 ml2 ml
Supported Vial Size:  3 ml3 ml
Supported Vial Size:  5 ml5 ml
Supported Vial Size:  10 ml10 ml
Supported Vial Size:  20 ml20 ml
Supported Vial Size:  20+ ml20+ ml
GMP Level:  CommercialCommercial
Biosafety Level:  Not SpecifiedNot Specified
Additional Services
Analytical Services are AvailableAnalytical Services
Formulation Development is AvailableFormulation Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Stability Studies are Not AvailableStability Studies
Prefilled Syringes are Not AvailablePrefilled Syringes
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Available

Last Update: 23MAY16

Send Inquiry about this Production Line
Sterile Manufacturing Services   Alcami Pre-Clinical - Commercial Lyophilized Fill
Location: Charleston, SC, United States
Main Details
Specialization:  Drug Product (Fill/Finish)Drug Product (Fill/Finish)
Dosage Form:  LyophilizedLyophilized
Batch Size:  20,000-50,00020,000-50,000
Supported Vial Size:  2 ml2 ml
Supported Vial Size:  3 ml3 ml
Supported Vial Size:  5 ml5 ml
Supported Vial Size:  10 ml10 ml
Supported Vial Size:  20 ml20 ml
Supported Vial Size:  20+ ml20+ ml
GMP Level:  CommercialCommercial
Biosafety Level:  Not SpecifiedNot Specified
Additional Services
Analytical Services are AvailableAnalytical Services
Formulation Development is AvailableFormulation Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Stability Studies are Not AvailableStability Studies
Prefilled Syringes are Not AvailablePrefilled Syringes
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Available

Last Update: 23MAY16

Send Inquiry about this Production Line

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