503B Outsourcing Facilities
Choose Spectrum Chemical as your manufacturing partner:
- FDA registered and inspected bicoastal cGMP facilities
- Certification to the ISO 9001:2015 standard
- DEA controlled substances (Schedules I-V)
- 1,200+ monograph chemical items
- 500+ in-depth scientific dossiers on monograph chemicals
- 400+ APIs covering more than 40 therapeutic areas
- 250+ top chemical excipients
- Worldwide sourcing capabilities for hard to source monographed chemicals
Decades of Experience in cGMP Manufacturing of Active Pharmaceutical Ingredients (APIs)
If your facility falls under the Drug Quality and Security Act (DQSA) of 2013 as a 503B Outsourcing Facility, then cGMP compliance is a requirement. Understanding FDA requirements for your facilities, your sterile processes and your API suppliers can be a daunting task. You need a partner with experience in cGMP manufacturing to help guide you through the process. Spectrum has been testing chemical ingredients in our quality control laboratories for nearly five decades. Spectrum’s four in-house analytical testing laboratories are fully equipped with state-of-the-art technology supported by best practices, current Good Laboratory Practices (cGLP) and current Good Manufacturing Practice (cGMP).
Spectrum’s quality team consists of numerous and lab technicians who perform more than 15,000 lab tests each year to ensure that our chemicals meet safety, purity and efficacy requirements. All of Spectrum’s monograph active pharmaceutical ingredients are manufactured, packaged, and held under cGMP per 21 CFR parts 210 & 211 and meet new USP 232/233 requirements.
Knowledge and Expertise to Help You Meet Today’s Rigorous cGMP Compliance Requirements
- Change control processes
- Electronic NDC submissions
- Lot sequestration
- Pedigree and supply chain verification
- Batch traceability
- Technical product support
- Regulatory compliance support
- Consulting services
- EDI/Web ordering
In-House Laboratory Expertise
Spectrum has numerous chemists and laboratory technicians with experience in instrumentation and analytical techniques to meet the needs of 503B outsourcing facilities. See all our Capabilities.
One-Stop-Shop for All Your 503B Manufacturing Needs
Spectrum offers the largest selection of compendial chemicals, laboratory chemicals/reagents, supplies, and equipment available from a single source. Whether you use our products in your analytical laboratory or production facility, Spectrum has you covered from bottles to bulk. Spectrum also offers over 200,000 supply and equipment products including safety products, fume hoods, electrochemistry, shakers/mixers, and balances used everyday in production facilities, research, QA, and QC laboratories.
Fine Chemicals
• Active pharmaceutical ingredients
• DEA controlled substances (I-V)
• Chemical excipients
• Multicompendial grade chemicals
• Bulk fine chemicals
Lab Testing Chemicals & Solutions
• ACS grade lab chemicals
• High-purity HPLC solvents
• Chemical reference standards
• ACS chemical testing solutions
• Buffers, solutions, and indicators
• Acids and bases
• USP reference standards
• USP test and volumetric solutions
• Sterile high purity water
• Saline solutions
• Custom solutions
Supplies and Equipment
• Balances
• Balance, Bulk Powder & Equipment Enclosures
• Biological Safety Cabinets & Enclosures
• Clean Benches
• Cleanroom Supplies
• Freeze Dryers
• Glassware Washers
• Garment, Gloves & Supplies
• Microbiology consumables
• Sterile/Non-Sterile USP 795/797/800 supplies
