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Quality
  • We have understood many years back that merely producing high quality products is not enough to meet current stringent regulatory guidelines.We strongly believe that the success of any organization lies in not only providing high quality products to the clients consistently but also produce them with quality and system driven procedures.
  • In this regard, we have established very stringent GMP systems as per the latest ICH guidelines for manufacture of intermediates and. We have well-established standard operating procedures (SOPs) at every point starting from raw material entry into warehouse, production of intermediates to finally dispatch of finished goods. We have stringent quality checks at every stage of this chain which gives our customers confidence that we can deliver products with consistent quality.
  • To maintain the GMP systems, we have a total of 10 QA personnel with 2 QA heads (for both units).
  • We also face several audits from various customers, both domestic and overseas, regularly without any issues.
  • For controlling quality of products, our QC lab is equipped with a total of 6 HPLCs and 4 GCs, and also all necessary equipment such as IR spectrometer, UV detector, MR apparatus, KF apparatus, Potentiometer, etc. We have 20 people working in QC departments of both units.
  • External analytical agencies, whenever used, are regularly audited by our QA department.
ISO certificate - Unit1
ISO certificate - Unit2
GMP certificate
WHO GMP certificate
FDA EIR Report certificate

Quality Controls