Research & Technology

Hikal has robust capabilities in research and technology

Capabilities

Our Research & Technology division partners with innovator companies in pharmaceuticals and animal health to develop new molecules or extend the lifecycle of existing molecules, and develops exclusive products for global clients. Our experienced team develops innovative, cost-effective and safe processes for molecules that go off patent and explores long-term products. Several products developed in-house have gone from lab scale to kilogram scale to pilot scale / validation scale to commercialization.

Client first

Hikal has a successful track record of delivering active pharmaceutical ingredients (APIs) and intermediates to global clients. Our facilities are built to meet the specific needs of clients and stringent requirements of the United States, European, and Japanese markets.

Leading edge technology

Our manufacturing facilities adopt new and emerging technologies to ensure smooth transfer of research and technology from the client to the plant and commercialization of processes. Our analytical equipment complies with global regulatory standards.

Green chemistry

Our plants have USFDA, PMDA, EU GMP, TGA approved facilities and adopt ICH Q7 and ISO 9001 quality standards. Hikal is a signatory of Responsible Care®, ISO 14001 and OHSAS 18001. Our comprehensive environment, health and safety (EHS) policy ensures that the interests of all constituents are safeguarded.

Infrastructure

Our research & technology capabilities blend expertise in chemistry with advanced facilities.

Infrastructure Labs
Synthetic laboratory 12
Lab for high potency products(OEL levels to 10 µg/m3) 1
Instrumentation lab 4
Process intensification lab 1
Kilo lab 2 (including 1 cGMP kilo lab)
High pressure lab 1
Solid state lab 1
Particle size engineering lab 1

Biocatalysis capabilities

  • Expertise in handling enzymes from lab scale to commercial manufacturing
  • Commercialized two APIs using enzymatic processes in two stages and a few are in the pipeline

Analytical capabilities

  • HPLC (Agilent)
  • GC
  • GCMS (Shimatzu)
  • UPLC (Waters)
  • LCMS (Shimatzu)
  • NMR 400 MHz
  • Stability chambers
  • Malvern particle size analyzer
  • Microbial analyzer
  • HR-MS
  • ICP-MS
  • DSC/TGA/ RC-1
  • Hot stage microscope
  • Spray drier
  • Optimax reactor system with Huber chiller,
    Turbidity probes, FBRM probe, HF-Cal Kit, pH probe

Technical capabilities

  • Asymmetric hydrogenation
  • Amide coupling
  • Reductive amination
  • Grignard and organolithium reactions
  • Hydrogenation
  • Isonitrile synthesis
  • Oxidation reactions
  • Reduction reactions
  • Esterification, hydrolysis, amidation
  • Cyanide chemistry
  • Enzyme reactions
  • Bromination
  • Chlorination
  • Sandmeyer reaction
  • Balz-Schiemann reaction
  • Halex reaction
  • Hofmann rearrangement
  • High temperature and pressure ammonolysis
  • Chiral resolutions
  • Carbon disulphide reactions
  • Ammoxidation (Gas/ Solid phase)

cGMP kilo lab

Hikal’s cGMP kilo lab in Pune allows scale-up of processes at our R&T labs and transfer of technology from global clients using advanced facilities:

  • 20 liter glass reactors
  • 50 liter glass reactors (2)
  • Heating/cooling system: –90°C to +200°C
  • 20 liter high vacuum distillation unit
  • Pressure Nutsche filter, centrifuge
  • Vacuum tray dryer
  • Miller and sifter

Advanced flow reactor

Hikal’s advanced flow reactor has a capacity of 1 MT per month with a dedicated mixing module for multiphase systems (liquid gas, immiscible liquids) and an on-demand pilot scale capability:

  • Capacity: 30 to 200 mL / min
  • Operating temperature: –60°C to +200°C
  • Operating pressure: ~4 bar
  • 20 liter high vacuum distillation unit

Pinch tube reactor

Hikal’s pinch tube reactor has a capacity of 5T per month with a scale-up capability of 100 kg per month:

  • Reaction time reduced from 14 hours to 90 seconds
  • Reaction temperature improved from 0°C-5°C to 30°C-50°C
  • Suitable for low temperature reactions: diazotization, nitration, etc.
  • Reduced footprint

Fixed bed vapor phase reactor

Hikal’s fixed bed vapor reactor has an annual capacity of 1,000 MT:

  • Material of construction: Stainless steel SS 316
  • Undertakes chemical reactions with efficient control as required over a vapor phase
  • Used for ammoxidation reaction (catalyst Co / Vanadium) – production of nitrile using ammonia and oxygen
  • Operation temperature 380 – 420°C
  • Reduced footprint

Research & Technology facilities of Hikal