Hikal

Overview

Hikal, established in 1988, is a contract development and manufacturing organization (CDMO) serving global pharmaceuticals, biotech, agrochemicals, and specialty chemicals companies. The company operates five manufacturing facilities in India (Maharashtra, Gujarat, and Bengaluru) plus a Research & Technology centre in Pune, all inspected and certified by global regulatory authorities.

Core Capabilities

Contract Research & Development:

• Synthesis, process development, and manufacturing services across APIs, active ingredients, regulated starting materials, impurities, building blocks, and chemical libraries
• Route scouting using electronic and in-house library databases
• Small-scale synthesis (multigram scale) with analytical method development
• Process development with rigorous quality and safety compliance
• Pilot-scale manufacturing in cGMP and non-cGMP plants
• Custom synthesis from gram to ton quantities

Contract Manufacturing:

• Process R&D for intellectual property development
• Routine and complex chemistry capabilities
• Technology transfer services via experienced Technology Absorption Team (TAT)
• APIs and advanced intermediates at FDA-approved facilities
• New molecular entity manufacturing compliant with FDA good manufacturing practices

Analytical & Characterization:

• Advanced analytical instrumentation: GC-MS/MS, LC-MS/MS, multi-nuclei NMR, preparative HPLC, GC, polarimeters, FT-IR, UV-visible spectrophotometry, Karl Fischer apparatus, flame photometry
• Impurity profiling and degradation product identification
• Full analytical method development and validation

Regulatory & Quality

All facilities have been inspected and certified by respective global regulatory authorities, including FDA approval for API and advanced intermediate manufacturing.