Expertise in API Intermediates

   At SOLANA LIFE SCIENCES PVT. LTD., our expertise in API Intermediates is built on a foundation of advanced synthetic chemistry and engineering rigour. We serve as a trusted link in the pharmaceutical supply chain, ensuring that the essential building blocks for life-saving drugs are manufactured to the highest standards of purity, consistency, and regulatory 

                                                            compliance (cGMP).

We specialize in managing the complexity inherent in pharmaceutical intermediates, offering solutions that reduce risk and accelerate your time-to-market:

• Route Scouting and Optimization: Our R&D team excels at developing and validating novel, cost-effective, and environmentally sustainable synthetic routes for complex target molecules.
• Multi-Step Synthesis: Proficiency in handling challenging and sensitive multi-step reactions, ensuring optimal yields and minimizing the formation of unwanted side products.
• Process Scale-Up and Validation: Seamless transition of laboratory procedures to commercial manufacturing scales. We meticulously validate all processes to guarantee reproducibility and regulatory readiness for full-scale production.

The integrity of an API Intermediate directly determines the safety and efficacy of the final drug product. Our control standards are exceptionally high:

• Impurity Isolation and Characterization: Advanced analytical techniques are used to identify, isolate, and characterize even trace-level impurities. We provide comprehensive impurity standards as required by regulatory submissions.
• Analytical Rigour: Utilizing state-of-the-art instruments, including HPLC, GC-MS, and NMR, to verify the structure, purity, and concentration of every batch.
• Batch-to-Batch Consistency: Strict adherence to validated SOPs ensures that every consignment you receive from SOLANA LIFE SCIENCES PVT. LTD. performs identically in your downstream processes.

Our expertise extends beyond the reactor. We ensure complete transparency and readiness for integration into your manufacturing ecosystem:

• cGMP Adherence: Our manufacturing facilities operate under strict Current Good Manufacturing Practices (cGMP), providing the confidence required for regulated environments.
• Comprehensive Documentation: We provide full documentation packages, including batch records, CoA (Certificate of Analysis), and necessary support for regulatory filings (DMF support).