Alcami Corporation
Pharmaceutical Companies
Why pick this one
Alcami provides sterile fill-finish and oral solid dose manufacturing from preclinical through commercial supply, with DEA-certified facilities and FDA/EMA-inspected operations.
Best for
- Preclinical-to-commercial pharmaceutical development programs
- Sterile injectable products requiring aseptic filling or lyophilization
- Pre-filled syringe and vial manufacturing
- Controlled substances requiring DEA Schedule I-V handling
- Oral solid dose products including tablets, capsules, powders, and pediatric tablets
- Clinical trial packaging requiring randomization, blinding, labeling, and serialization
Look elsewhere if
- Retail prescription dispensing or walk-in pharmacy services are needed
- A consumer-facing pharmaceutical provider is required instead of a contract development and manufacturing organization
Specialties
- Sterile fill-finish manufacturing
- Aseptic filling of liquid and lyophilized vials
- Pre-filled syringe manufacturing
- Suspension and emulsion manufacturing
- Lyophilization
- Oral solid dose manufacturing
- Controlled-substance manufacturing
- Pharmaceutical packaging, labeling, and clinical kitting
- Formulation development
Certifications
- DEA-certified facilities
- DEA Schedule I-V manufacturing authorization
- FDA-compliant operations
- EMA-compliant operations
- MHRA-compliant operations
- PDMA-compliant operations
- cGMP compliance
- Annex 1 compliance
What makes them different
- Supports pharmaceutical development and manufacturing from preclinical stages through commercial supply
- Has six sterile fill-finish lines for liquid vials, lyophilized vials, and pre-filled syringes
- Handles DEA Schedule I-V controlled substances and highly potent active pharmaceutical ingredients
- Sterile fill-finish facilities in Research Triangle Park, North Carolina, and Charleston, South Carolina, support batch sizes up to 200L and 1000L respectively
- Has contributed to commercialization of more than 50 programs
Distilled from this business's own website.
Contact & Location
- Address
- 627 Davis Dr Ste 100, Morrisville, NC 27560-7101
- Phone
- 18005754224
- Website
- https://www.alcami.com
Services
- Drug product development and manufacturing
- Laboratory and analytical services
- Packaging and labeling
- Pharmaceutical storage
- Environmental monitoring
- Calibration and validation
- Aliquoting and sampling
- Cold-chain storage and shipment