Custom Synthesis

Multinational Companies looking to outsource products and services regard Aurobindo Pharma as a valuable partner.

Tie-ups with Aurobindo Pharma give customers the competitive edge through faster product development and optimised costs. The Company can help reduce the transition time between drug discovery, development and entry into the market. The customer gains with reproducible, innovative solutions to synthetic chemistry problems.

Custom synthesis at Aurobindo Pharma is tailored to meet the customer needs, be it as a laboratory scale-up, commercial scale-up or post commercialisation stages.

Aurobindo Pharma offers its comprehensive services along with a promise of quality and consistency. These are made available at a speed and cost that are mutually beneficial.

There is a dedicated kilo lab at the R & D Centre itself. There is a pilot plant that's a plant by itself. All the six manufacturing plants of the Company conform to international standards, with a variety of reactors - more than 300 SS, glass lined, high pressure and sterile reactors, spray drier, and hydrogenators. All are cGMP compliant.

The Company offers custom synthesis solutions that cater to outsourcing needs of customers, specifically in two key areas:

Organic Custom Synthesis

Chemical Development

Under the Organic Custom Synthesis module, the Company offers a full range of services to meet the varying needs by utilizing established synthetic routes, modifying customer processes, designing novel routes with complete chemical, chromatographic, spectroscopic back up for starting materials, intermediates, reference compounds, metabolites, resolution of enantiomers, structural isomers, etc.

As part of the Chemical Development service, the Company offers scale-up of existing processes, preparation of intermediates in milligrams to kilo lots, processes optimization, development and use of purification techniques and alternate process routes.

Aurobindo Pharma promises the outsourcing partner benefits that are both commercial and qualitative. Some of the notable features of this arrangement are:

Strict confidentiality and utmost secrecy is maintained through absolute adherence to the non-disclosure clause. A highly efficient supply chain management and optimal utilisation of capacities coupled with chemical skills, enables Aurobindo Pharma to pass on substantial cost benefits to its customers.
Aurobindo Pharma is a stickler for deadlines. Recently, the Company commercialised an API involving a 14-step process with 5 chiral centers in just 13 weeks. A huge library with syndicated databases and the latest software ensures quick and efficient literature/patent survey and retrieval of information.
Multi disciplinary project teams interface with the customer from the start, to ensure a seamless integrated approach. Their responsiveness enable rapid execution of projects. Besides conforming to cGMP and cGLP, due attention is given to Safety, Health & Environment aspects.
The Company has harnessed the latest in communication technology - dedicated server, video conferencing, tele-conferencing etc to ensure constant communication throughout the life of the project. A right mix of instrumentation and production expertise ensures due emphasis on profiling, characterisation of compounds, reduction in impurities, chiral resolution and impurity profiling. All these ensure the highest quality of deliverables and optimise the yields.

Chemical Capabilities

Some of the chemical reactions undertaken at the production facilities are,

  • Asymmetric Synthesis
  • Optical Resolution
  • High Pressure Catalytic Hydrogenation
  • Handling Butyl Lithium
  • Bromination
  • Chlorination
  • Sulfonation
  • Acylation
  • Reductive Alkylation
  • Reduction
  • Quarternisations
  • Grignard
  • Cyanation
  • Carbethoxylation
  • Oximation
  • Low Temperature (-80 C)
  • Epoxidation
  • Oxidations involving potassium permanganate, Hydrogen peroxide etc
  • High temperature Condensation (+250 C)
  • Friedel - Crafts

Analytical Equipments

The state-of-the-art equipments in place include NMR 300 MHz, LCMS/MS, GCMS, GCs, HPLCs, ion chromatography, laser diffraction particle size analyzer, XRD, FT-Raman spectro-photometer, Atomic absorption spectra The Team Aurobindo

Aurobindo Pharma's R & D centre is manned by over 700 scientists who are highly qualified and experienced in chemical research analytical development, safety-health environment, regulatory requirements, engineering and information technology, quality assurance, IPF etc. They provide a comprehensive and complete technical support. Complementing them are over 500 qualified and well trained chemists, quality assurance and control personnel.