AAIPharma
A U.S.-based contract development and manufacturing organization (CDMO) with 45+ years of experience offering integrated services across analytical development, formulation and CMC, sterile and oral solid dose manufacturing, packaging/labeling, microbiology, cGMP storage, and pharma support services. Operates multiple U.S. campuses and audited facilities to support preclinical through commercial supply for small molecules, biologics, and controlled substances.
Industries
Nr. of Employees
large (251-1000)
AAIPharma
Wilmington, North Carolina, United States, North America
Patents
Synthetic method for the preparation of a 3-[5-amino-4-(3-cyanobenzoyl)-pyrazol compound
US-11649213-B2
View Details
Synthetic method for the preparation of a 3-[5-amino-4-(3-cyanobenzoyl)-pyrazol compound
US-11649213-B2
View DetailsProducts
Drug Product Manufacturing
Manufacturing services for sterile fill-finish and oral solid dose drug products from preclinical to commercial supply stages.
Laboratory Services
Analytical and microbiological laboratory testing services for pharmaceutical and biotech companies, offered standalone or bundled with manufacturing.
Pharmaceutical Storage & Services
cGMP-compliant storage solutions for pharmaceuticals and biologics, including calibration and validation services.
Drug Product Manufacturing
Manufacturing services for sterile fill-finish and oral solid dose drug products from preclinical to commercial supply stages.
Laboratory Services
Analytical and microbiological laboratory testing services for pharmaceutical and biotech companies, offered standalone or bundled with manufacturing.
Pharmaceutical Storage & Services
cGMP-compliant storage solutions for pharmaceuticals and biologics, including calibration and validation services.
Services
Aseptic and terminal sterilization filling for vials and prefilled syringes, lyophilization, isolator technology, and handling of high‑potency and controlled substances; supports clinical through commercial supply.
Tablet and capsule manufacturing including granulation, coating, roller compaction, encapsulation, and comparator blinding from FIH to commercial scale.
Method establishment, validation, transfer, routine and compendial testing for small molecules and biologics, with ELN integration.
Validated stability, refrigerated, freezer, ultra‑low and cryogenic storage; validated cold‑chain transport, aliquoting/sampling, labeling, kitting, and reference standards management.
Clinical and commercial labeling, blinding/randomization, serialization and aggregation, vial and syringe labeling, blistering and secondary packaging, and global distribution support.
Metrology and accredited calibration, commissioning/qualification/validation services, environmental monitoring and cleanroom support, and on‑site technical staffing.
Aseptic and terminal sterilization filling for vials and prefilled syringes, lyophilization, isolator technology, and handling of high‑potency and controlled substances; supports clinical through commercial supply.
Tablet and capsule manufacturing including granulation, coating, roller compaction, encapsulation, and comparator blinding from FIH to commercial scale.
Method establishment, validation, transfer, routine and compendial testing for small molecules and biologics, with ELN integration.
Validated stability, refrigerated, freezer, ultra‑low and cryogenic storage; validated cold‑chain transport, aliquoting/sampling, labeling, kitting, and reference standards management.
Clinical and commercial labeling, blinding/randomization, serialization and aggregation, vial and syringe labeling, blistering and secondary packaging, and global distribution support.
Metrology and accredited calibration, commissioning/qualification/validation services, environmental monitoring and cleanroom support, and on‑site technical staffing.
Expertise Areas
- Sterile and parenteral manufacturing
- Oral solid dose development and manufacture
- Analytical method development and compendial testing
- Biologics characterization and bioassay development
Key Technologies
- HPLC/UPLC
- LC‑MS / Q‑TOF
- GC/MS
- ICP‑MS
News & Updates
Participation in AAPS 2025 PHARMSCI 360 conference.
Participation in DCAT Week 2026 event.
Announcement of laboratory services expansion in Durham, NC to support growing demand in biologics.
Facilities successfully inspected by major regulatory agencies (FDA, EMA, TGA, PMDA, MHRA, ANVISA, Health Canada, MPA & IMB); facilities in good standing with regulatory authorities.
Supported over 500 IND filings and more than 50 NDA/ANDA/NADA submissions; involvement in commercialization of 50+ programs.
Participation in AAPS 2025 PHARMSCI 360 conference.
Participation in DCAT Week 2026 event.
Announcement of laboratory services expansion in Durham, NC to support growing demand in biologics.
Facilities successfully inspected by major regulatory agencies (FDA, EMA, TGA, PMDA, MHRA, ANVISA, Health Canada, MPA & IMB); facilities in good standing with regulatory authorities.
Supported over 500 IND filings and more than 50 NDA/ANDA/NADA submissions; involvement in commercialization of 50+ programs.