Alcami

4620 Creekstone Drive

Durham, NC 27703

United States

Phone: 800-575-4224

Alcami is a world-class fully-integrated end-to-end contract development and manufacturing organization (CDMO) headquartered in North Carolina, with executive offices in Durham and Wilmington. Alcami provides customizable and innovative services to small and mid-size pharmaceutical and biotechnology companies by offering individualized and integrated services across multiple areas. Alcami connects its clients with innovative solutions for 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.

Company Description

Services & Capabilities

With approximately 1,000 employees operating at ten global locations in the United States, Europe, and Asia our combined capabilities include:

API development and manufacturing
Solid state chemistry
Biotherapeutic development and testing
Formulation development
Analytical development and testing
Abuse-deterrent studies
Stability studies
Elemental impurities testing
Microbiology and chemistry
Oral solid dose and parenteral drug product development and manufacturing
Packaging and labeling
Serialized batch lines

Facilities

Operations: Charleston, SC; Durham, NC; Edison, NJ; Germantown, WI; St. Louis, MO; Weert, Netherlands; Wilmington, NC

Commercial Offices: Cambridge, MA; San Diego, CA; Tokyo, Japan

Pharmacovigilance in Australia and New Zealand
Drug safety in Australia is regulated via the Office of Medicines Safety Monitoring (OMSM) (synonymous with Adverse Drug Reaction Advisory Committee), a branch of the Therapeutic Goods Administration (TGA). In New Zealand, Medsafe is the regulatory agency responsible for overseeing drug safety/ ...
Drug Supply Modelling in Clinical Trials (Statistical Methodology)
Drug supply chain is very costly and is a well-recognized bottleneck at the design and managing of clinical trials. The innovative risk-based statistical approach to modelling drug supply demand for a single study is proposed. The approach uses the developed technique for predicting the number of ...
Criteria for CMO Selection
Major pharmaceutical and emerging biopharmaceutical companieshave a plethora of choices in utilizing contract-manufacturingorganizations (CMOs) available in the global market place for their custom synthesis needs. However, establishing a collaborative relationship with a few manageable and reliable...
Off-shoring Stability Testing Conducting Cost-efficient Compliant Long-term Stability Studies at Overseas CRO’...
The research-based pharmaceutical industry has always accommodated change, and like other businesses, is increasingly becoming cost constrained due in part to the rising investment required to develop new medicines and the global economic environment.
Biopharmaceutical Contract Manufacturing Market: Outsourcing – What Services are Biomanufacturing Directors ...
As the world economy and financial markets contracted in 2009, so did the market for biopharmaceutical contract manufacturer services.
Outsourcing Compound Inventory Trend or Real Benefits?
A screening compound collection is recognized as a valuable asset by most pharmaceutical companies and Compound Management is now a key component of the Drug Discovery process.

Alcami

4620 Creekstone Drive

Durham, NC 27703

United States

Phone: 800-575-4224

Website: www.alcaminow.com

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Alcami Corporate Profile

Alcami

Company Description

Services & Capabilities

Facilities

Content

Pharmacovigilance in Australia and New Zealand

Drug Supply Modelling in Clinical Trials (Statistical Methodology)

Criteria for CMO Selection

Off-shoring Stability Testing Conducting Cost-efficient Compliant Long-term Stability Studies at Overseas CRO’...

Biopharmaceutical Contract Manufacturing Market: Outsourcing – What Services are Biomanufacturing Directors ...

Outsourcing Compound Inventory Trend or Real Benefits?

Alcami

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