API Synthetic Mastery
Executing intricate multi-step reaction sequences, Cytonova Labs aligns process chemistry with ICH Q7 standards to deliver pharmacopeial grade APIs for critical therapeutic applications.
API Technical Scope
SYNTHETIC STRATEGY
KILOGRAM SCALE-UP
REGULATORY DOSSIERS
Engineering stereoselective pathways and catalytic optimizations for complex molecular structures.
Technological transfer from bench-top R&D to multi-kilogram GMP commercial batch manufacturing.
Full alignment with FDA, EMA, and ICH guidelines for robust CMC documentation and DMF submissions.
Analytical Method Validation Center
cGMP PROTOCOLS — ICH Q2 VALIDATION — IMPURITY PROFILING — STABILITY TESTING — cGMP PROTOCOLS — ICH Q2 VALIDATION — IMPURITY PROFILING — STABILITY TESTING —
Therapeutic Portfolio
We facilitate high-precision batch production of controlled substances and advanced key starting materials (KSMs), ensuring comprehensive analytical verification for pharmaceutical R&D and manufacturing.
Validated Drug Substances
Industrial-scale synthesis of essential pharmacopeial APIs with stringent control of elemental and organic impurities.
Complex Intermediates
Novel organic synthesis of chiral building blocks, optimizing yield and enantiomeric purity for high-value targets.
Custom Synthesis
Bespoke process development focusing on Route Scouting and Design of Experiments (DoE) for clinical supply needs.
Dynamic Process Analytics
Procurement Partnership
Technical RfQ
Liaise with our technical sales team for API specifications, batch capacity, Lead-times, and DMF availability details.
Regulatory Documents
We maintain cGMP site certifications. For ASMF, CEP, or specific impurity data requests, please contact our regulatory affairs lead at quality@cytonovalabs.co.in