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ITAAN PHARMA
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    • HOME
    • ABOUT
    • DEVELOPMENT
    • MANUFACTURING
    • QUALITY
    • NEWS & ARTICLES
    • CONTACT
ITAAN PHARMA
  • HOME
  • ABOUT
  • DEVELOPMENT
  • MANUFACTURING
  • QUALITY
  • NEWS & ARTICLES
  • CONTACT

MANUFACTURING OPERATIONS

At ITAAN PHARMA, we set the benchmark for injectable manufacturing excellence, offering seamless solutions across diverse vial types and fill volumes. Our expert-led manufacturing team brings deep experience in injectable commercialization, ensuring precision, quality, and compliance at every stage. Designed with meticulous attention to detail, our facility meets stringent cleanroom environment specifications and adheres to Good Manufacturing Practice (GMP) standards mandated for regulated markets. 


We understand the criticality of aseptic operations. Our facility provides ample operational square footage. The state-of-the-art facility houses advanced vial filling lines for glass and polypropylene (PP) vials, delivering unmatched flexibility to adapt to evolving market demands. From small-batch production to high-volume commercial supply with short lead times, we seamlessly support clinical and commercial phases - ready to integrate with the patient's needs. Additionally, we are fully equipped to handle alcohol-based formulations. We maintain rigorous environmental monitoring, process monitoring, ongoing aseptic training, routine process qualification (PQ) and aseptic process simulation (APS) protocols upholding the highest quality and regulatory standards. Our rigorous, proactive management/ownership oversight minimizes compliance risks and ensures operational excellence.


Glass Vials:

  • Supports 2R to 100R vials (liquid and lyophilized)
  • 10m² lyophilizer capacity: Processes up to 19,000 vials (10mL). Identical R&D and commercial lyophilizer models for seamless scale-up.


Polypropylene (PP) Vials:

  • Accommodates 5mL to 250mL PP vials or RTU PP vials
  • Designed for terminal sterilization

info@itaanpharma.com

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