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rajesh@azicopharma.com
 
 
 
 
 
 
 
Azico has world class infrastructure for manufacturing APIs complying with the requirements of Regulated and Semi Regulated markets. All our labs are GLP compliant and our manufacturing plants are US FDA approvable, WHO GMP approvable and ISO certifiable.
Azico’s state of art API manufacturing facility is located at the Pharma City, Vizag (Visakhapatnam), India. The facility is created in accordance to cGMP requirements and strictly following ICHQ7 quality system guidelines.
The Pharma City Vizag offers unique advantages in the form of complete infrastructure facilities package including key resources, skilled man power, common effluent treatment plant & all major licenses under single window and access to airport and sea port within 20 km.
 
  • Azico is preparing its facility for inviting audits from USFDA, EMEA, PMDA-Japan, KFDA-Korea, Anvisa-Brazil, Cofepris-Mexico, TGA-Australia, UK-MHRA, Afssaps-France, WHO and MOH of major countries.
  • cGMP/USFDA compliance plant for commercial production volume with dedicated Clean Rooms designed & supported with ventilation system up to packaging of Finish Product.
  • A Kilo level cum Pilot Plant built in compliance of cGMP/USFDA guidelines with dedicated Clean Room Area up to packaging of Finish Product
  • Well equipped R&D Laboratory supported with experience team of scientists
  • Microbiology Lab
  • Well equipped to handle reactions at the temperature -80°c to +250°C range
  • 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

  • Azico 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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