17+ years of zero regulatory action letters. ADEEP's quality framework sets the global benchmark for API manufacturing — from raw material qualification to finished product release.
Each certification reflects our systematic commitment to quality, safety, and environmental responsibility across all manufacturing operations.
Certified Good Manufacturing Practices aligned with World Health Organization guidelines — ensuring global supply chain acceptability.
Current Good Manufacturing Practice and Schedule M compliant facilities ensuring rigorous pharmaceutical quality standards.
Quality Management System standard ensuring continuous product consistency, process control, and systematic improvement.
Environmental Management System for sustainable waste management, energy efficiency, and green chemistry initiatives.
Occupational Health & Safety Management ensuring the highest standard of worker safety across all manufacturing sites.
Authorized statutory manufacturing licenses for active pharmaceutical ingredients & advanced intermediates from CDSCO.
Active technical dossiers, regulatory filings, and official certificates supporting global customer filings across regulated markets.
Certificates of Suitability (CEP) dossiers aligned with the European Directorate for the Quality of Medicines (EDQM) and European Pharmacopoeia monographs for commercial API exports.
Official Written Confirmation from CDSCO / Government of India under Directive 2011/62/EU certifying GMP compliance for lawful active substance exports to EU nations.
Full CTD Module 3 dossiers containing complete Route of Synthesis, ICH Q3A/B impurity profiles, batch analysis, and 36-month ICH Q1A stability data.
17+ years of impeccable quality track record across all product categories, customer inspections, and regulatory audits.
Our differentiated capabilities create enduring competitive advantages for our pharma partners across the global supply chain.
India's premier commercial-scale enzymatic synthesis capability — delivering >99.8% ee chiral APIs with 40% reduced solvent usage vs. traditional routes.
Complete backward integration from starting materials to finished APIs — eliminating supply chain risks and ensuring consistent quality & competitive pricing.
Guaranteed commercial quote, technical dossier, and COA delivery within 24 hours for all qualified inquiries — fastest in the Indian API sector.
Complete DMF (Drug Master File), CoA, Route of Synthesis, ICH Q3 impurity profiles, and ICH Q1 stability data available for all commercial products.
Zero Liquid Discharge systems, automated gas scrubbers, solvent recovery units, CSR community education & healthcare, and solar energy integration across manufacturing sites.
Industry's lowest attrition rate. PhD chemists, QA specialists, and regulatory affairs professionals with cumulative 2,500+ years of pharma expertise.
Active participation in India's Production Linked Incentive scheme for APIs — ensuring capacity expansion, price competitiveness, and long-term supply security.
State-of-the-art analytical labs with HPLC, GC, UV-Vis spectroscopy, NMR, and microbial testing — eliminating third-party delays in release testing.
Comprehensive analytical testing performed throughout every stage of production — from raw material qualification to final product release.
Request DMFs, CoAs, stability data, and Route of Synthesis documents for any commercial API or intermediate.
