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rajesh@azicopharma.com
 
 
 
 
 
 
R&D is the focus area at Azico and is handled by our Technical Director who has 25 years experience of development and scale up of Generic APIs mainly for regulated markets of USA & Europe.

Skills and teamwork of scientist is the key in the research & development function of an API manufacturing entity aiming for growth in regulated markets. Azico has been able to develop a strong team of skilled scientists having expertise in identifying suitable process for development of selected products for regulated markets sought by the Global Generic companies in USA/Europe.
  • State of art Kilo Level cum Pilot Plant complying to cGMP requirement with its dedicated clean room areas up to packaging of final products
  • Plant is suitable for Audits by USFDA/EMEA/PMDA and any regulatory agencies
  • R&D laboratory is fully equipped for Milligram to kilogram level scale up of  APIs and APIs intermediates.
  • R&D facility is equipped with international standard fume hoods and walk-in types fume hoods, hydrogenators  and other equipments to perform all types chemical reactions.
  • Development of Generic APIs for Regulated markets of both Niche Small volume to moderate to high volume
  • In house expertise in R&D leadership of Azico for development of Niche products
  • Backward integration capabilities in sister companies 
  • Process Research & Continual development of Robust Process
  • Analytical Research & Development Laboratory for Generic APIs development, Process Research and special chemical entities
  • Experienced team for carrying out Analytical Method Development & Validations. Preparation of specifications of key RMs, API intermediates and APIs   as per ICH guidelines / FDA requirement. Successful Transfer as well implementation of analytical methods, specifications during and post trials /validations to team of manufacturing/ QC/QA
  • Well equipped to handle reactions at the temperature   -80°c to +250°C range. 

ADL is equipped with state of art equipments for achieving high level of standards as

  • HPLC with LCMS  
  • HPLC PDA Detector
  • HPLC Preparative for impurity isolation
  • HPLC for routine analysis
  • GC Head Space
  • GC Regular
 
 
 
 
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