Interchem
Pharmaceutical sourcing and contract manufacturing organization supplying active pharmaceutical ingredients (APIs), antibiotics, and custom chemical intermediates. Provides supplier qualification, CGMP-focused regulatory support, DMF management and electronic DMF conversion, quality assurance advisory, and project management for custom manufacture and technology transfer. Operates a selective network of FDA-compliant manufacturers and maintains centralized regulatory/product information to support NDA/ANDA development and inspections. Partners with an external QA consultancy to augment CGMP compliance, enforcement guidance, training, and validation support.
Industries
Nr. of Employees
small (1-50)
Interchem
Interchem Corporation USA, 120 Rt 17 North, Paramus, NJ 07652
Products
Active Pharmaceutical Ingredients (APIs)
Catalog and supply of APIs across multiple therapeutic classes sourced from audited, FDA-compliant manufacturers; includes sample request and technical documentation.
Antibiotics (sterile and formulated forms)
Sourcing of cephalosporins, penicillins, carbapenems and other anti-infectives in lyophilized, injectable, and bag formats from FDA- and European-compliant manufacturers.
Custom chemical intermediates
Catalog of specialized fine chemical intermediates and custom synthesis capabilities with CAS-referenced products and custom formulation options.
Active Pharmaceutical Ingredients (APIs)
Catalog and supply of APIs across multiple therapeutic classes sourced from audited, FDA-compliant manufacturers; includes sample request and technical documentation.
Antibiotics (sterile and formulated forms)
Sourcing of cephalosporins, penicillins, carbapenems and other anti-infectives in lyophilized, injectable, and bag formats from FDA- and European-compliant manufacturers.
Custom chemical intermediates
Catalog of specialized fine chemical intermediates and custom synthesis capabilities with CAS-referenced products and custom formulation options.
Services
Identification and supply of APIs, antibiotics and specialty intermediates from audited, FDA-compliant manufacturers; includes supplier qualification and sample provision.
Project management and sourcing for custom intermediates and contract synthesis, including technology transfer and commercialization support.
Regulatory advisory, DMF pre-review and electronic DMF conversion, patent assessments and support during inspections, augmented by external QA consultancy services that provide CGMP compliance solutions, enforcement guidance, training programs, and design/validation audit support for construction projects.
Identification and supply of APIs, antibiotics and specialty intermediates from audited, FDA-compliant manufacturers; includes supplier qualification and sample provision.
Project management and sourcing for custom intermediates and contract synthesis, including technology transfer and commercialization support.
Regulatory advisory, DMF pre-review and electronic DMF conversion, patent assessments and support during inspections, augmented by external QA consultancy services that provide CGMP compliance solutions, enforcement guidance, training programs, and design/validation audit support for construction projects.
Expertise Areas
- Pharmaceutical sourcing and distribution
- API and antibiotic supply
- Custom synthesis and contract manufacturing
- Regulatory compliance and DMF management
Key Technologies
- Flow chemistry
- Asymmetric hydrogenation
- Chiral chemistry
- Preparative chromatography