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Manufacturing Facility
MANUFACTURING

Robust Manufacturing. Global Standards.

Built on four decades of process expertise — a manufacturing ecosystem designed for quality, scale, and global regulatory compliance.

PHARMACEUTICAL QUALITY SYSTEM

Quality as a Foundation

Dano operates under a comprehensive Pharmaceutical Quality System (PQS) certified to ISO 9001:2015 and cGMP standards. Our quality strategy ensures a state of control at every stage of the product lifecycle.

Product Integrity (SISPQ)

Safety, Identity, Strength, Purity, and Quality in every dose.

Data Integrity

Complete, consistent, and accurate manufacturing and testing data.

Quality Risk Management

Science-based approach to identify and mitigate risks proactively.

Full Traceability

End-to-End traceability from raw material sourcing to final product distribution.

Continuous Improvement

PDCA cycle for constant process refinement and operational excellence.

Quality Control Lab
MANUFACTURING CAPABILITIES

End-to-End Infrastructure

Full vertical integration enabling effective control over quality, timelines, and supply continuity across the value chain.

Drug Substance Manufacturing Icon

Drug Substance Manufacturing

Specialised suites for upstream and downstream processing of high-quality vaccine antigens, supported by validated processes and containment systems.

  • Fermentation-based toxin production
  • Chemical inactivation and purification
  • Validated upstream and downstream processes
  • Compliant with I.P., B.P., and WHO TRS

Drug Product Manufacturing

Automated sterile formulation and fill-finish lines ensuring precision, aseptic integrity, and consistency in every vial across multiple formats.

  • Automated filling — vials and ampoules
  • ISO-classified cleanrooms with validated HVAC
  • Aseptic process integrity
  • cGMP-compliant visual inspection

Quality Control

Modern QC laboratories with advanced analytical instrumentation for comprehensive microbiological and biological testing.

  • In-process and batch release testing
  • Biological potency assays
  • Batch release to NRA
  • Independent Quality Unit authority

Bio-Safety

Stringent bio-safety and containment principles with specialised engineering controls and robust waste management systems.

  • Controlled access and containment areas
  • Validated decontamination systems
  • Robust biological waste management
  • Personnel and environmental protection

Sustainable Operations

Sustainability is embedded into our operational philosophy. Through optimised resource utilisation and waste minimisation, we strive to reduce our ecological footprint.

  • Optimised water management and energy efficiency
  • Waste minimisation across all production stages
  • Responsible raw material sourcing practices
  • Sustainable and resilient manufacturing future

End-to-End Expertise

By integrating Drug Substance manufacturing with Drug Product formulation, Dano offers a seamless end-to-end solution with enhanced oversight.

  • Single-site DS and DP integration
  • Strict cost control and supply continuity
  • Enhanced quality oversight at every stage
  • Reliable execution for global delivery
CERTIFICATION & COMPLIANCE

Aligned with Global Standards

Our facility and quality systems are aligned with requirements prescribed by leading national and international regulatory authorities.

WHO
GMP

WHO Good Manufacturing Practices

Aligned with WHO-GMP guidelines ensuring vaccines are consistently produced to meet international expectations for quality, safety, and efficacy.

ISO
9001

ISO 9001:2015 Quality Management

Certified quality management system demonstrating structured process control, customer focus, and risk management across all business functions.

cGMP
GLP

GMP & GLP Compliance

Compliance with Good Manufacturing and Laboratory Practices as prescribed by the Government of India — ensuring process reliability and data integrity.

INT'L
REG

International Regulatory Approvals

Product registrations and facility approvals from multiple national regulatory authorities across the world enabling compliant global supply.

Interested in Partnering with Dano?

Our facility with integrated DS+DP capabilities is available for CMO partnerships

Contact

Caring for Life

Whether you are looking for a partnership, need product information, or have a general query — our team is here to help.

+91 9281443266
info@danovaccines.com
Mon–Sat, 9:00 AM – 5:30 PM IST
Get in Touch

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