AAIPharma Services Corp.

For more than 30 years, AAIPharma Services has provided drug product development services to pharma, biotech, and medical device companies around the world. Our team of 450 pharmaceutical professionals, scientists and engineers pride themselves on providing solutions to the most difficult drug development and manufacturing challenges. No matter how large or small your company is, we can tailor a program to fit your specific needs. Our customers may choose from specific services--including analytical and formulation services, clinical packaging and distribution, contract manufacturing and oral drug delivery technologies--or a complete product development package to meet their objectives.

AAIPharma Services provides cGMP manufacturing services for clinical and commercial products at its solid dosage and sterile product manufacturing facilities. The facilities located in Charleston, SC (sterile) and Wilmington, NC (solid dose) are comparable in size/staffing and provide flexible capabilities for the processing of a wide range of pharmaceutical drug products, including controlled substances and potent compounds. Clinical manufacturing activity ranges from Phase I through III trials with scale-up and validation support to address commercial launch requirements and to support subsequent commercial supply. Both sites are FDA and MHRA approved and produce products for the US and European markets.

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Locations


United States
Wilmington Solid Dose Manufacturing
1726 N. 23rd St.
Wilmington, NC  28405
United States, North America

GMP Experience
AAIPharma Services' solid dose manufacturing facility is located in Wilmington, North Carolina. The plant specializes in solid oral dosage forms, toxic and potent compounds, and more.
United States
Charleston Sterile Manufacturing
4221 Faber Place Drive
Charleston, SC  29405
United States, North America

GMP Experience
AAIPharma Services' sterile products manufacturing facility is located in Charleston, South Carolina. Our 48,000 sq. ft. facility develops and manufactures sterile products for small molecules.

Contacts


Barry Johnson
Sr. Marketing Manager

Production Lines

Charleston Sterile Manufacturing  
Location: Charleston, SC, United States
Main Details
Specialization:  Drug Product (Fill/Finish)Drug Product (Fill/Finish)
Dosage Form:  LiquidLiquid
Batch Size:  5,000-20,0005,000-20,000
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 Not AvailableAnalytical Services
Formulation Development is AvailableFormulation Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Stability Studies are AvailableStability Studies
Prefilled Syringes are Not AvailablePrefilled Syringes
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Available

Last Update: 23OCT09

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Charleston Sterile Manufacturing  
Location: Charleston, SC, United States
Main Details
Specialization:  Drug Product (Fill/Finish)Drug Product (Fill/Finish)
Dosage Form:  LyophilizedLyophilized
Batch Size:  5,000-20,0005,000-20,000
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 Not AvailableAnalytical Services
Formulation Development is AvailableFormulation Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Stability Studies are AvailableStability Studies
Prefilled Syringes are Not AvailablePrefilled Syringes
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Available

Last Update: 23OCT09

Send Inquiry about this Production Line
Charleston Sterile Manufacturing   AAIPharma Phase I/II Liquid Fill Finish
Location: Charleston, SC, United States
Main Details
Specialization:  Drug Product (Fill/Finish)Drug Product (Fill/Finish)
Dosage Form:  LiquidLiquid
Batch Size:  1-5,0001-5,000
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:  Phase I/IIPhase I/II
Biosafety Level:  Not SpecifiedNot Specified
Additional Services
Analytical Services are Not AvailableAnalytical Services
Formulation Development is AvailableFormulation Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Stability Studies are AvailableStability Studies
Prefilled Syringes are Not AvailablePrefilled Syringes
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Available

Last Update: 30OCT09

Send Inquiry about this Production Line
Charleston Sterile Manufacturing   AAIPharma Phase III/Commercial FIll Finish
Location: Charleston, SC, United States
Main Details
Specialization:  Drug Product (Fill/Finish)Drug Product (Fill/Finish)
Dosage Form:  LiquidLiquid
Batch Size:  5,000-20,0005,000-20,000
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:  Phase IIIPhase III
Biosafety Level:  Not SpecifiedNot Specified
Additional Services
Analytical Services are Not AvailableAnalytical Services
Formulation Development is AvailableFormulation Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Stability Studies are AvailableStability Studies
Prefilled Syringes are Not AvailablePrefilled Syringes
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Available

Last Update: 30OCT09

Send Inquiry about this Production Line
Charleston Sterile Manufacturing   AAIPharma Phase I/II Lyo
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:  Phase I/IIPhase I/II
Biosafety Level:  Not SpecifiedNot Specified
Additional Services
Analytical Services are Not AvailableAnalytical Services
Formulation Development is AvailableFormulation Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Stability Studies are AvailableStability Studies
Prefilled Syringes are Not AvailablePrefilled Syringes
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Available

Last Update: 30OCT09

Send Inquiry about this Production Line
Charleston Sterile Manufacturing   AAIPharma Phase III and Commercial Lyo
Location: Charleston, SC, United States
Main Details
Specialization:  Drug Product (Fill/Finish)Drug Product (Fill/Finish)
Dosage Form:  LyophilizedLyophilized
Batch Size:  5,000-20,0005,000-20,000
GMP Level:  Phase I/IIPhase I/II
Biosafety Level:  Not SpecifiedNot Specified
Additional Services
Analytical Services are Not AvailableAnalytical Services
Formulation Development is AvailableFormulation Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Stability Studies are AvailableStability Studies
Prefilled Syringes are Not AvailablePrefilled Syringes
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Available

Last Update: 30OCT09

Send Inquiry about this Production Line

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