Chemistry Capabilities
Driven by Technical Expertise & Versatility
Medkem, through its partner network, handles a diverse range of complex chemical reactions and specialized chemistries. Our technical team ensures that every process—from lab-scale R&D to commercial production—is optimized for safety, yield, and purity.
Key Reaction Capabilities:
- Chiral Chemistry:Asymmetric synthesis and chiral resolution.
- High-Pressure Reactions:Hydrogenation and carbonylation.
- Low-Temperature Chemistry:Cryogenic reactions down to -80°C.
- Organometallic Chemistry:Grignard reagents and Lithium-based reactions.
- Hazardous Chemistry:Professional handling of Nitration, Halogenation (Chlorination, Bromination), and Cyanation.
Complex Multi-step Synthesis: Specialized in creating high-purity Intermediates and Specialty Chemicals
Quality & Regulatory Compliance
Our Commitment: Uncompromised Standards
At Medkem, quality is not a department; it is a mindset. We understand that regulatory compliance is the “passport” to global markets. We ensure that every product we supply meets the most stringent international pharmacopeia standards.
Our Compliance Framework:
- Global Accreditations:We partner exclusively with facilities approved by world-class regulatory bodies, including USFDA, EUGMP, EDQM, WHO-GMP, MFDS and
- Rigorous Auditing:Our in-house technical team conducts comprehensive Quality Audits of manufacturing sites to ensure strict adherence to cGMP (current Good Manufacturing Practices) and ICH guidelines.
- Pre-Shipment Inspections (PSI):To ensure consistency, we perform meticulous physical inspections and sample testing before any batch leaves the facility.
- Documentation Excellence:We provide full support for regulatory filings, including DMF (Drug Master Files), ASMF, and CEP/COS
- Total Traceability:From raw material sourcing to final delivery, we maintain a transparent and traceable supply chain.
- Our Quality Policy
“Medkem is committed to delivering value-added products that consistently meet national and international standards. We actively pursue excellence through effective quality management, innovative technologies and a culture of continuous improvement”.