Global Active Pharmaceutical Ingredients (API) Services
Access comprehensive international data on API manufacturers, suppliers, and traders serving the global pharmaceutical industry.
Our platform provides verified information on GMP, EU-GMP, FDA, and WHO-certified producers, including product portfolios, therapeutic categories, and technical documentation (DMF, CEP, CoA, MSDS). Explore insights into sourcing options, licensing opportunities, pricing benchmarks, and supply chain networks for both generic and innovative active ingredients. With continuously updated API intelligence, you can identify reliable global partners, ensure regulatory compliance, and optimize your procurement and manufacturing strategies across diverse markets.
API Manufacturing & Services (All Types)
- API synthesis and bulk production
- Contract and third-party API manufacturing (CDMO services)
- Generic API production for off-patent molecules
- Custom and specialty API development
- High-potency API (HPAPI) manufacturing
- Biotechnological API production (enzymes, peptides, biosimilars)
- Fermentation-based API production (antibiotics, hormones, proteins)
- Hormonal API and sterile API manufacturing
- Aseptic and lyophilized API production
- API intermediates and raw material synthesis
- Controlled substance and narcotic API production
- Analytical method development and validation
- Stability testing and impurity profiling
- Quality control and batch release with COA
- Process development and scale-up from lab to commercial stage
- DMF (Drug Master File) preparation and submission
- CEP and technical dossier support (CTD / eCTD format)
- Regulatory documentation for FDA, EMA, WHO, MOH approvals
- GMP / EU-GMP / FDA-compliant manufacturing services
- Process optimization and impurity reduction
- Pilot-scale and R&D batch manufacturing
- Packaging, labeling, and serialization for APIs
- Temperature-controlled and GDP-compliant transport
- Environmental and safety compliance (EHS, waste management)
- Product compatibility and stability studies
- Documentation translation and technical data management
- Product licensing and technology transfer consulting
- Analytical laboratory and testing services
- Batch traceability and certification (GMP, COA, MSDS)
- Post-manufacturing storage and export logistics
Global API Distributors & Trading Companies
- Regional API importers and wholesalers
- National API supply and distribution companies
- Authorized distributors for specific API manufacturers
- Exclusive agents and brand representatives
- Pharmaceutical raw material importers
- Generic API distributors (for off-patent molecules)
- Specialty API distributors (oncology, antibiotics, peptides, etc.)
- Biotechnological API distributors (biosimilars, recombinant proteins)
- Controlled substance and narcotic API distributors (licensed)
- Sterile and injectable-grade API distributors
- Hormonal API and high-potency API distributors (HPAPI)
- Veterinary API distributors
- API intermediates and raw material suppliers
- Contract supply and sourcing agents for APIs
- Regulatory-compliant distributors (GMP / GDP certified)
- Laboratory and R&D API suppliers (pilot and small-scale quantities)
- Distributors specialized in EU-GMP and FDA-approved APIs
- Cold chain and temperature-controlled API logistics providers
- Chemical and excipient distributors also handling APIs
- Market access and licensing-oriented API agents
- Distributor networks serving manufacturers and formulators
- API stockists and warehousing distributors
- Tender and institutional API suppliers
- Export-oriented API distributors for emerging markets
- API distributors offering documentation support (DMF, COA, MSDS)
- Online B2B API marketplace distributors
- Hybrid pharma-chemical distributors (handling both API & formulations)
- API supply partners for compounding pharmacies
- Regional representatives for API sales in GCC, CIS, MENA, and EU markets
Global Certifications & Compliance
🏭 Quality Certifications
- GMP / EU-GMP Compliance
- FDA Approval & Inspections
- WHO Prequalification
- ISO 9001 Quality Management
- ICH Guidelines Compliance
📄 Technical Documentation
- Drug Master Files (DMF)
- CEP Certificates (EDQM)
- Certificate of Analysis (CoA)
- Material Safety Data Sheets (MSDS)
- CTD/eCTD Dossier Preparation
Strategic API Sourcing Advantages
Quality Assurance
Access GMP, EU-GMP, and FDA-certified manufacturers with verified quality standards.
Global Network
Connect with reliable API partners across international markets and regions.
Regulatory Compliance
Ensure full compliance with international regulatory requirements and documentation.
Supply Chain Optimization
Optimize procurement strategies with comprehensive market intelligence and pricing data.
We conduct comprehensive verification including GMP certification checks, regulatory compliance validation, facility audits, product quality testing, client reference verification, and continuous performance monitoring. All API partners must demonstrate proven track records and maintain current regulatory approvals.
Yes, we provide comprehensive support for regulatory documentation including DMF preparation, CEP applications, technical dossier development (CTD/eCTD format), and submissions to FDA, EMA, WHO, and various national health authorities worldwide.
Absolutely. We specialize in sourcing specialized APIs including High-Potency APIs (HPAPI), sterile APIs, hormonal APIs, controlled substances, biotechnological APIs, and other complex active ingredients from verified manufacturers with appropriate facilities and certifications.
We ensure supply chain reliability through multi-source verification, capacity assessment, logistics optimization, quality assurance protocols, and continuous monitoring of manufacturer performance and market availability.
Yes, we provide comprehensive support for technology transfer, custom API development, process optimization, and scale-up services. Our network includes CDMOs and manufacturers specializing in custom synthesis from laboratory scale to commercial production.