SpectraSynth specializes in the custom synthesis of pharmaceutical impurities, including API impurities and degradants, as well as the production of pharmaceutical reference standards and intermediates for drug development and regulatory use.
We are headquartered in India and serve clients across the globe, including pharmaceutical innovators, generic manufacturers, and regulatory laboratories.
Yes, SpectraSynth is both ISO 9001:2015 certified and GMP compliant, ensuring high standards of quality, safety, and regulatory compliance.
We provide custom synthesized impurities and degradants, pharmaceutical reference standards with full characterization, intermediates for early-stage and commercial manufacturing, and CRO services from research and development to scale-up.
We work with the pharmaceutical and biotech industries, supporting drug development, regulatory submissions, and quality control processes worldwide.
We follow stringent global quality standards, with rigorous testing, documentation, and compliance at every step—from synthesis to delivery.
Our strengths include expertise in complex API impurity synthesis, rapid turnaround times, flexible manufacturing capabilities, and a proven track record as a trusted supplier in India and abroad.
Absolutely. We specialize in custom synthesis, offering tailored solutions based on client specifications and project requirements.
Yes, we provide comprehensive CRO services in India, supporting clients from R&D through to scale-up and commercialization.
You can reach out to us via our Contact page, and our technical team will respond promptly to discuss your requirements or provide a quote.
We provide NMR, Mass, IR, UV, HPLC/GC purity, and Certificates of Analysis (COA) with all products.
Yes, we can synthesize new impurities based on structure or degradation pathways.
Yes, we offer method development and validation services in compliance with regulatory standards.
Yes, our products comply with ICH, FDA, and EMA guidelines.
Yes, we ship globally with all required documentation.
Standard projects take 2–6 weeks. We also offer expedited options.
Yes, we offer synthesis of stable isotope-labeled compounds on request.
Yes, all batches undergo strict QC and are fully traceable.
We work with pharma companies, CROs, CMOs, research labs, and regulatory bodies.
Yes, we sign NDAs and follow strict data protection protocols.