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Comply. Trace. Deliver with Confidence.

Meet API regulatory requirements with confidence using the API Mandate Compliance Solution by Dash Technologies & Labels Pvt. Ltd.

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End-to-End Traceability, Identification & Compliance for Active Pharmaceutical Ingredients (API)

Dash Technologies & Labels Pvt. Ltd. offers a purpose-built API Mandate Compliance Solution to help pharmaceutical manufacturers comply with Indian and global regulatory requirements for identification, traceability, and reporting of Active Pharmaceutical Ingredients (APIs). The solution enables secure coding, traceability, verification, and audit readiness across API manufacturing, packaging, storage, and dispatch operations.

The Dash API Compliance Solution is designed for API manufacturers, bulk drug producers, intermediates manufacturers, and exporters, ensuring smooth compliance without disrupting existing processes.

Core Functional Capabilities

  • Unique IDs for API batches, drums, bags, and containers
  • Barcode / QR code–based identification
  • Configurable coding structures
  • Secure and non-duplicative ID generation

  • Integration with industrial label printers
  • Printing of batch, lot, retest date, quantity & regulatory data
  • Barcode / QR code verification through scanners or vision systems
  • Prevention of incorrect or unauthorized labeling

  • Batch-level and container-level traceability
  • Movement tracking across manufacturing, QC, warehouse, and dispatch
  • Parent–child relationship between batch and containers
  • Complete product genealogy

The API Mandate Compliance Solution integrates seamlessly with:

  • MES (WIP) for batch and process data
  • WMS for storage, transfer, and dispatch tracking
  • ERP systems (SAP, Oracle, Microsoft Dynamics)
  • Digital Link Platform for verification
  • Track & Trace (PrintEZ / PharmID) where applicable

This ensures consistent and reliable API data across systems.

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Feature Image

  • Time-stamped and user-stamped activity logs
  • Batch-wise compliance reports
  • Container movement and reconciliation reports
  • Inspection-ready digital documentation

Supports compliance with:

  • Indian regulatory expectations (CDSCO / DGFT)
  • Customer audits and quality agreements
  • Global best practices for API traceability

  • Real-time API inventory visibility
  • Batch and container status dashboards
  • Movement and dispatch traceability reports
  • Deviation and Exception analysis

All reports are secure, configurable, and exportable.

  • On-Premise deployment
  • Private Cloud deployment
  • Hybrid architecture
  • Role-based access control

Scalable from single-site API plants to multi-location operations.

  • Guaranteed API identification and traceability
  • Faster and smoother regulatory audits
  • Reduced risk of compliance gaps
  • Improved supply chain transparency
  • Stronger trust with formulation customers
  • Future-ready for evolving API mandates

Regulatory Context & Compliance Need

Regulatory authorities increasingly require:

  • Clear identification and traceability of APIs
  • Batch-level and container-level tracking
  • Transparency across supply chain movement
  • Quick investigation and recall readiness
  • Audit-friendly digital records

Non-compliance may result in:

  • Regulatory observations and warnings
  • Supply disruptions to formulators
  • Export delays or rejections
  • Loss of customer trust

Dash provides a future-ready digital compliance framework aligned with evolving API mandates.

Key Challenges in API Operations

API manufacturers often face:

  • Manual labeling and record-keeping
  • Limited traceability beyond batch records
  • Difficulty in tracking drums, bags, and containers
  • Inconsistent data between production, warehouse, and dispatch
  • Time-consuming regulatory audits

The Dash API Compliance Solution closes these gaps through digital identification and traceability.

Why Dash Technologies & Labels Pvt. Ltd.?

The Dash API Mandate Compliance Solution ensures that APIs are traceable, verifiable, and audit-ready—from production to customer delivery.

Deep understanding of API manufacturing and compliance

Proven expertise in labeling, identification & traceability

End-to-end capability: software, hardware & integration

Practical solutions aligned with real-world operations

Reliable implementation, validation & local support

Book a free live demo tailored to your business need

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