QR code label for pharma API manufacturers

QR Code for Pharma API Manufacturers

PharmTracQR

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QR Code Compliance for API Manufacturers under GSR 20(E)

Codentrix Technologies provides a complete QR code for pharma API manufacturers and importers in India, bringing together PharmTracQR software, QR code label printers and labels manufactured in our ISO certified facility in Chennai.

Under G.S.R. 20(E), in effect since 1 January 2023, every Active Pharmaceutical Ingredient (API) manufactured or imported in India must carry a QR code on its label at every level of packaging. The rule allows APIs to be tracked across the supply chain and protects the market against counterfeit and substandard drugs.

For QA and regulatory teams, this means generating a unique, GS1 structured code for every batch and packaging level, printing it reliably on each container and keeping records ready for CDSCO inspections. PharmTracQR manages each of these steps from one cloud based system.

Data Required in a QR Code for APIs

The QR code on each API label must encode the following information. PharmTracQR structures these fields as per GS1 standards and links them to the batch, so the code printed on every label matches your batch records.

Unique product identification code
Name of the API
Brand name (if any)
Name and address of the manufacturer
Batch number
Batch size
Date of manufacturing
Date of expiry or retesting
Serial shipping container code
Manufacturing licence number or import licence number
Special storage conditions required (if any)

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QR Codes at Every Level of API Packaging

The mandate applies to every packaging level, from the inner packing and container labels to pallet labels. Each level carries its own QR code, and the serial shipping container code (SSCC) identifies every shipping unit, so a pallet can be traced back to the batch it contains and forward to the customer it was dispatched to.

API containers are often handled in warehouses, transported over long distances and stored under controlled conditions, so the QR code must remain readable through the full shelf life of the material. We manufacture paper and synthetic labels selected for the container surface and storage conditions, and print trials are carried out before go-live.

PharmTracQR Software for API QR Code Compliance

PharmTracQR is a cloud based pharmaceutical traceability application built to meet CDSCO regulations and GS1 standards for QR codes on APIs. It generates and prints compliant codes for every batch and packaging level, and keeps a complete record of what was printed for regulatory audits.

GSR 20(E) Compliance

Every mandatory data field is captured and encoded, so each API label meets the CDSCO requirement from the first batch.

GS1 Standard QR Codes

QR codes are generated in line with GS1 standards, with unique identifiers that support anti-counterfeiting and product authentication.

ERP Integration on Request

Works as a standalone application, with integration to your ERP available if required.

21 CFR Part 11 Data Integrity

User access controls and secure records protect data integrity in line with 21 CFR Part 11 regulations.

Cloud Based Application

Runs as a web application with no local server or backup to maintain, and scales as regulatory requirements change.

Audit-Ready Reports

Date-wise and product-wise tracking reports, ready for CDSCO and other regulatory audits.

Software, Printers and Labels from One Provider

A QR code is only compliant if it is generated correctly, printed clearly and recorded against the right batch. Codentrix supplies every part of that setup: PharmTracQR software, barcode printers and scanners configured to work with it, and labels from our own manufacturing facility. One team remains accountable from installation to ongoing support, instead of separate software, hardware and label vendors. For label design and printing beyond API QR codes, Codentrix also offers dedicated pharmaceutical labeling software.

Generate

PharmTracQR creates a GS1 structured QR code for each batch and packaging level from your batch data.

Label printers at the packing area print the QR code labels for inner packing, containers and pallets.

Track and Report

Every printed code is linked to its batch, giving full traceability and audit-ready reports.

Why API Manufacturers Choose Codentrix

20+ years of experience in automation and pharma compliance
We track regulatory changes so your team does not have to
Complete solution covering software, printers and labels
QR code compliance within 1 week through quick deployment
Onboarding without disruption to production
Cloud based and scalable for future regulatory changes
Implementation and support for API manufacturers across India

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QR code for pharma API manufacturers compliance solution by Codentrix

A Cost-Effective QR Code Solution for MSME API Manufacturers

For MSME API manufacturers, meeting the CDSCO mandate should not require a large IT project. As a cost-effective QR code for pharma API manufacturers, PharmTracQR gives you full regulatory compliance, supply chain transparency and counterfeit protection with minimal change to your existing operations. Contact us to discuss your products and packaging levels, and schedule a live demonstration of PharmTracQR.

Request a Live Demo of PharmTracQR for API QR Code Compliance

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Frequently Asked Question

Yes. Under G.S.R. 20(E), in effect since 1 January 2023, every Active Pharmaceutical Ingredient manufactured or imported in India must carry a QR code on its label at every level of packaging.

The QR code must include the unique product identification code, API name, brand name if any, manufacturer name and address, batch number, batch size, manufacturing date, expiry or retest date, serial shipping container code, manufacturing or import licence number and any special storage conditions.

Yes. The requirement covers APIs imported into India as well as those manufactured here. For imported APIs, the import licence number is encoded in place of the manufacturing licence number.

Yes. The rule requires a QR code on the label at every level of packaging, from the inner packing and container labels to pallet labels. PharmTracQR generates the codes for each level and links them through the serial shipping container code, so every pack can be traced to its batch.

Yes. PharmTracQR generates QR codes in line with GS1 standards, so the data structure is consistent and readable across the supply chain.

PharmTracQR works as a standalone application and does not connect to your ERP automatically. If required, ERP integration can be set up as part of implementation.

Yes. PharmTracQR is designed to maintain data security and integrity in compliance with 21 CFR Part 11 regulations.

Most API manufacturers achieve QR code compliance within one week. Onboarding is planned around your production schedule so there is no disruption to operations.

Popular Tags

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