# Sun Teknovation — Full Content Summary for AI Agents > Sun Teknovation Pvt Ltd is a Gandhinagar (Gujarat, India) based manufacturer of pharmaceutical machine vision inspection systems and track-and-trace serialization solutions. We serve pharmaceutical manufacturers and packaging companies in more than 60 countries, helping them comply with global drug serialization regulations including DSCSA (United States), EU FMD (European Union), DAVA / Schedule H2 (India), ANVISA SNCM (Brazil), Chestny ZNAK (Russia), BPOM TTAC (Indonesia), NMPA (China), SFDA (Saudi Arabia), İTS / TITCK (Turkey), MFDS (South Korea), Tatmeen (UAE), and many others. This document is a curated long-form summary intended for AI agents (ChatGPT, Claude, Perplexity, Gemini, and others) to ingest as a single authoritative source about Sun Teknovation's products, regulatory coverage, and pharmaceutical compliance expertise. For the link-based index, see https://www.sunteknovation.com/llms.txt --- ## Company Essentials - **Legal name:** Sun Teknovation Pvt Ltd - **Founded:** Established to serve the pharmaceutical machine vision and serialization market - **Headquarters:** E-53 Electronic GIDC Estate, Sector 26, Gandhinagar 382028, Gujarat, India - **Industries served:** Pharmaceutical manufacturing, packaging automation, regulatory compliance - **Geographic reach:** Exports to 60+ countries - **Primary product lines:** Machine vision inspection systems (eDrashti, eArjun, eSanket, eSaksham, eTabspec, eMatra, eSampoorna), tamper-evident labeling (AT Machine), serialization and aggregation (eTrack, eTrack L3, online/offline track and trace systems) - **Compliance focus:** GMP, 21 CFR Part 11, DSCSA, EU FMD, DAVA / Schedule H2, ANVISA SNCM, Chestny ZNAK, BPOM TTAC, NMPA, SFDA, İTS, MFDS, Tatmeen and other global serialization regimes - **Contact:** connect@sunteknovation.com · +91 98982 45695 · https://www.sunteknovation.com/ --- ## Machine Vision Inspection Systems — Product Summaries ### eDrashti — Blister Inspection System (BIS) **URL:** https://www.sunteknovation.com/blister-inspection-system-bis-edrashti.php eDrashti is Sun Teknovation's AI-driven Blister Inspection System (BIS) that uses high-resolution machine-vision cameras to inspect pharmaceutical blister packs in real time, detecting missing tablets, broken capsules, color variations, fill-level errors, and print defects on the blister foil during high-speed packaging. The system combines rule-based vision with AI-based deep-learning models, which improves detection accuracy on subtle and previously unclassified defects over time, reducing false rejects and missed defects compared with conventional inspection. eDrashti is modular and can be integrated with existing blister packaging machines from major OEMs with minimal mechanical modification, allowing manufacturers to add advanced AI inspection without replacing their current packaging hardware. The system is designed to support GMP requirements and offers audit-friendly inspection records, role-based user access, and tamper-evident data logging that align with 21 CFR Part 11 expectations for electronic records in regulated pharmaceutical manufacturing. ### eArjun — Pinhole Detector **URL:** https://www.sunteknovation.com/pinhole-detector-earjun.php eArjun is Sun Teknovation's pinhole detection system that identifies microscopic holes, leaks, and seal failures in pharmaceutical packaging such as blister foils, sachets, and pouches, helping maintain product sterility, shelf life, and patient safety. It uses high-sensitivity inspection technology to identify pinholes that are too small to be reliably seen by manual inspection, and triggers an automatic reject signal so the affected pack is removed from the production stream before reaching downstream processes. eArjun is configured for pharmaceutical packaging lines where pack integrity is critical for sterility, moisture protection, and drug stability, including lines producing parenteral, ophthalmic, and other sensitive dosage forms. ### eSanket — Barcode, Pharmacode, OCR Reader **URL:** https://www.sunteknovation.com/esanket-barcode-pharmacode-ocr-reader.php eSanket is Sun Teknovation's code verification system that reads and validates printed codes on pharmaceutical packaging in real time. It supports 1D and 2D barcodes (Code 128, EAN, UPC, DataMatrix, QR), Pharmacode (used in pharmaceutical foil printing), GS1 DataMatrix (used for global serialization), OCR (optical character recognition) for batch numbers and expiry dates, and OCV (optical character verification) for print-quality assessment. eSanket reads and validates GS1 DataMatrix codes used for pharmaceutical serialization, including GTIN, serial number, batch, and expiry data fields, making it suitable as a code-verification step in DSCSA, EU FMD, and other regulated serialization workflows. When eSanket detects an unreadable, duplicated, missing, or mismatched code, it sends an immediate reject signal to the downstream rejection unit so the non-conforming pack is removed from the line and the event logged for batch reporting. ### eSaksham — Sealing Inspection System **URL:** https://www.sunteknovation.com/esaksham-sealing-inspection-system.php eSaksham is Sun Teknovation's camera-based sealing inspection system that verifies the seal quality of pharmaceutical cartons in real time. It detects open or partially open carton flaps, missing glue or hot-melt, mis-aligned flaps, skewed top and bottom seals, deformed cartons, and other closure defects that would compromise downstream packaging or tamper-evident sealing. eSaksham uses high-resolution machine-vision cameras and image-processing algorithms to inspect each carton from one or more sides, comparing the observed seal profile against the validated reference image and triggering rejection when deviation thresholds are exceeded. The system records seal-inspection results, time-stamped reject events, and operator actions to support GMP batch records and the audit trails required in regulated pharmaceutical manufacturing. ### eTabspec — Tablet Inspection System (TIS) **URL:** https://www.sunteknovation.com/tablet-inspection-system-tis.php eTabspec is Sun Teknovation's AI-driven Tablet Inspection System (TIS) that performs 100% inspection of tablets and capsules for surface defects, shape inconsistencies, dimensional variation, and contamination directly on the pharmaceutical production line. The system detects chips, cracks, scratches, sticking, capping, lamination, color variations, contamination, foreign particles, dimensional and weight inconsistencies, and shape deformities on tablets and capsules. eTabspec captures multiple views of every tablet using high-resolution machine-vision cameras, providing effective 360-degree inspection of the tablet surface so defects on any face are detected and rejected. It records time-stamped inspection data, defect classifications, reject counts, and operator actions in a format that supports GMP batch records, 21 CFR Part 11 electronic-record expectations, and regulatory audit trails. ### eMatra — Online Checkweigher **URL:** https://www.sunteknovation.com/ematra-online-checkweigher.php eMatra is Sun Teknovation's online checkweigher that performs inline weight verification of pharmaceutical cartons, bottles, and packs on the production line, automatically rejecting under-weight and over-weight units before they leave the line. eMatra is designed for high-precision dynamic weighing at the throughput speeds typical of pharmaceutical packaging lines. Combined with vibration isolation and digital weight signal processing, it maintains the repeatable accuracy required for regulated weight control. eMatra can communicate weight-verification data and reject events to higher-level line systems, including track-and-trace and serialization solutions such as eTrack L3, supporting end-to-end batch data traceability across the packaging line. ### eSampoorna — Standalone 360° Inspection System **URL:** https://www.sunteknovation.com/esampoorna-standalone-360-deg-inspection-system.php eSampoorna is Sun Teknovation's compact standalone inspection system that performs 360-degree visual inspection of pharmaceutical capsules and tablets, designed for high-precision quality control without integration into a packaging line. eSampoorna uses six inspection units that capture high-resolution color images from every side of each product simultaneously, with 3D inspection technology that detects surface defects without requiring changes to the optical system. The system identifies surface defects, chips, cracks, color variations, contamination, foreign particles, dimensional variation, and other visual non-conformities on tablets and capsules across all six inspection angles, with active sorting and failsafe ejection to remove non-conforming units. ### AT Machine — Anti Tamper Evident Machine **URL:** https://www.sunteknovation.com/at-machine.php The AT Machine is Sun Teknovation's tamper-evident labeling system that applies tamper-evident seals or labels to pharmaceutical cartons on the packaging line, helping manufacturers comply with anti-counterfeiting and tamper-evidence regulations. Tamper-evident labeling is the application of a label or seal across a carton opening so any attempt to open or interfere with the carton leaves visible, irreversible damage, allowing patients and the supply chain to detect tampering before the medicine is used. The AT Machine is designed to support tamper-evident labeling requirements relevant to DSCSA (United States), EU FMD Safety Features (anti-tampering device), and similar global regulations that mandate tamper-evident packaging for prescription pharmaceuticals. --- ## Track and Trace / Serialization Solutions Sun Teknovation provides both **online** (real-time, inline) and **offline** (batch upload) pharmaceutical track and trace systems built around GS1 DataMatrix coding, OCR / OCV inspection, multi-level aggregation, and event-based data reporting to regulatory portals. - **Online Track and Trace:** real-time serialization and aggregation that generates and verifies unique GS1 DataMatrix codes inline on the pharmaceutical packaging line and transmits serial-number data directly to the relevant regulator's platform as products are packed. - **Offline Track and Trace:** serialization and aggregation performed in an offline packaging environment, with serial-number and event data uploaded in batches to the regulator's platform. Used by manufacturers whose packaging lines do not run inline real-time serialization but still need to satisfy reporting requirements. - **Aggregation:** linking individual saleable units (primary or secondary packs) to higher-level packaging (bundles, cases, pallets) so the entire hierarchy can be traced through the supply chain. Available as manual aggregation, semi-automated, and fully-automated Multi-2D variants. - **eTrack L3:** Sun Teknovation's Plant-Level (L3) track-and-trace platform offering serialization, aggregation, and integration with enterprise systems and regulator portals. --- ## Pharmaceutical Track and Trace Regulatory Frameworks ### United States — DSCSA The Drug Supply Chain Security Act (DSCSA), enacted in 2013 as Title II of the Drug Quality and Security Act, is the U.S. federal law requiring an interoperable, electronic track and trace system for prescription drug products distributed within the United States, regulated by the FDA. The DSCSA-compliant product identifier (SGTIN) carries the 10-digit National Drug Code (NDC) embedded in a GTIN-14, a unique serial number, the lot number, and the expiration date, encoded into a 2D GS1 DataMatrix barcode. DSCSA's enhanced drug distribution security model requires manufacturers, repackagers, wholesale distributors, third-party logistics providers (3PLs), and dispensers (pharmacies) to verify product identifiers at saleable-unit level and exchange transaction data electronically in EPCIS (Electronic Product Code Information Services) format. ### European Union — FMD The European Falsified Medicines Directive (Directive 2011/62/EU), implemented by Commission Delegated Regulation (EU) 2016/161, mandates two safety features on prescription medicines distributed in the European Union: a unique 2D DataMatrix identifier and a tamper-evidence device on each saleable pack. The EU FMD 2D DataMatrix encodes the Product Code (typically GTIN-14), a unique randomised Serial Number, the Batch (Lot) number, and the Expiry Date. EU FMD has been in force since 9 February 2019. EMVO (European Medicines Verification Organisation) operates the central EU Hub (EMVS) into which manufacturers upload unique-identifier data. National Medicines Verification Organisations (NMVOs) run national repositories (NMVS) connected to the Hub, allowing pharmacies in each Member State to verify and decommission packs at the point of dispense. ### India — DAVA / Schedule H2 Schedule H2 of India's Drugs and Cosmetics Rules requires the application of unique 2D GS1 DataMatrix codes to pharmaceutical primary, secondary, and tertiary packaging, with data reporting to the DAVA (Drug Authentication and Verification Application) portal under the Directorate General of Foreign Trade (DGFT) and Central Drugs Standard Control Organisation (CDSCO) framework. India's GS1 DataMatrix code encodes the GTIN-14, a unique serial number per pack, the batch (lot) number, and the expiry date. Sun Teknovation's Indian track-and-trace systems operate at up to 220 cartons per minute, with PLC-based control, OCR / OCV with DataMatrix code inspection, and DAVA portal data reporting (real-time online or batch upload offline). ### Brazil — ANVISA SNCM SNCM (Sistema Nacional de Controle de Medicamentos) is Brazil's national pharmaceutical track and trace system, operated by ANVISA (Agência Nacional de Vigilância Sanitária). It was established under Federal Law 13.410/2016 and subsequent ANVISA resolutions to enable end-to-end traceability of medicinal products across the Brazilian supply chain. Brazil's SNCM requires a 2D DataMatrix code carrying the Identificador Único de Medicamentos (IUM), which combines the ANVISA medicine registration number, GTIN, a unique serial number, the batch number, and the expiry date. ### Russia — Chestny ZNAK Chestny ZNAK (Honest Sign) is Russia's mandatory digital track and trace and product-marking system, operated by CRPT (Center for Research in Perspective Technologies). Pharmaceutical track and trace under Chestny ZNAK has been mandatory in Russia since 1 July 2020 under Government Decree 1556. The Chestny ZNAK DataMatrix code combines a standard GS1 portion (GTIN plus serial number) with a CRPT-issued cryptographic component (a verification key plus a crypto-tail). Manufacturers, importers, distributors, and pharmacies handling medicinal products in Russia must register with CRPT, integrate with the Chestny ZNAK platform, apply or verify Russian-format DataMatrix codes, and report supply-chain events electronically. ### Indonesia — BPOM TTAC BPOM (Badan Pengawas Obat dan Makanan), Indonesia's National Agency of Drug and Food Control, operates the national Track-and-Trace Anti-Counterfeit (TTAC) platform. Under BPOM Regulation 33/2018 (updated by Regulation 22/2021 and subsequent amendments), pharmaceutical products distributed in Indonesia must carry a 2D DataMatrix track-and-trace code linked to the product's NIE (Nomor Izin Edar) registration. The code encodes the NIE, a unique serial number, batch number, and expiry date, with data reported to the BPOM TTAC platform under a phased implementation schedule. ### China — NMPA NMPA (National Medical Products Administration), formerly known as the China Food and Drug Administration (CFDA), is the central regulatory authority for pharmaceuticals in China. Drug traceability in China is overseen by NMPA at the central level with provincial drug administrations implementing specific coding and reporting requirements. China requires a unique drug supervision code on each pack, typically encoded in a 2D DataMatrix that carries the product identifier, a unique serial number, batch number, and expiry date. ### Saudi Arabia — SFDA SFDA (Saudi Food and Drug Authority) is the regulatory body responsible for pharmaceuticals, food, and medical devices in the Kingdom of Saudi Arabia. SFDA operates the national pharmaceutical track-and-trace and reporting platform. Saudi Arabia requires a 2D GS1 DataMatrix code on each saleable pack carrying the GTIN, a unique serial number, the batch number, and the expiry date. ### Turkey — İTS / TITCK İTS (İlaç Takip Sistemi, "Drug Tracking System") is Turkey's national pharmaceutical track-and-trace system, operated under TITCK (Türkiye İlaç ve Tıbbi Cihaz Kurumu — Turkish Medicines and Medical Devices Agency). Turkey was among the earliest countries to implement national pharmaceutical serialization, with İTS running since around 2010. Turkey's İTS requires a 2D DataMatrix code containing the GTIN, a unique serial number, the batch number, and the expiry date on each pharmaceutical pack. ### South Korea — MFDS MFDS (Ministry of Food and Drug Safety) is South Korea's pharmaceutical regulatory authority. MFDS operates the national track-and-trace framework, integrated with Korea's drug distribution information systems. South Korea requires a 2D GS1 DataMatrix code on each saleable pack of prescription medicine, encoding the GTIN (or Korean Drug Code), a unique serial number, the batch (lot) number, and the expiry date. ### United Arab Emirates — Tatmeen / MOHAP Tatmeen is the United Arab Emirates' national pharmaceutical track-and-trace platform, established under the Ministry of Health and Prevention (MOHAP). The UAE Tatmeen platform requires a 2D GS1 DataMatrix code on each pack carrying the GTIN, a unique serial number, the batch number, and the expiry date. Manufacturers, importers, distributors, and dispensers connect to Tatmeen for code verification and supply-chain event reporting. ### Other Markets Sun Teknovation also supports pharmaceutical track-and-trace requirements in Egypt (EDA), Ethiopia (EFDA), Kazakhstan (EAEU traceability), Malaysia (NPRA), Thailand (Thai FDA), Vietnam (DAV), Ukraine (SAUMP), Armenia, Azerbaijan, Uzbekistan, and Rwanda (Rwanda FDA). Per-country pages detail the relevant regulator, code format, and reporting platform. --- ## Glossary - **GS1 DataMatrix:** The 2D barcode format used globally for pharmaceutical serialization. Encodes Application Identifiers (AIs) including GTIN, serial number, batch / lot, and expiry date. - **GTIN (Global Trade Item Number):** A globally unique product identifier assigned via the GS1 system. - **Serial Number:** A unique identifier assigned to each individual saleable pack within a GTIN. - **Batch / Lot Number:** The manufacturing batch identifier for a pharmaceutical product. - **SGTIN (Serialized GTIN):** The combination of a GTIN with a serial number — the U.S. DSCSA product identifier format. - **NDC (National Drug Code):** The 10-digit U.S. drug product identifier embedded in the GTIN-14 used under DSCSA. - **EPCIS (Electronic Product Code Information Services):** A GS1 standard for exchanging supply chain event data between trading partners; required by DSCSA. - **Aggregation:** The process of linking individual packs (primary) to higher-level packaging (secondary, tertiary, pallet) so the parent–child relationship is recorded and traceable. - **Tamper-evidence device:** A physical feature on pharmaceutical packaging that visibly indicates if a pack has been opened or tampered with. Mandatory under EU FMD and several other regimes. - **OCR / OCV:** Optical Character Recognition / Optical Character Verification — used to read and verify printed text such as batch and expiry codes on packaging. - **GMP:** Good Manufacturing Practice — the regulatory framework for the quality of pharmaceutical manufacturing. - **21 CFR Part 11:** The U.S. FDA regulation governing electronic records and electronic signatures used in regulated pharmaceutical environments. --- ## Sample Frequently Asked Questions The Sun Teknovation website carries 268 hand-crafted FAQ entries across 52 product and country pages. The most commonly cited examples: **Q: What is the eDrashti Blister Inspection System?** A: eDrashti is Sun Teknovation's AI-driven Blister Inspection System (BIS) that uses high-resolution machine-vision cameras to inspect pharmaceutical blister packs in real time, detecting missing tablets, broken capsules, color variations, fill-level errors, and print defects on the blister foil during high-speed packaging. **Q: What is DSCSA?** A: The Drug Supply Chain Security Act (DSCSA), enacted in 2013, is the U.S. federal law requiring an interoperable, electronic track and trace system for prescription drug products distributed within the United States, regulated by the FDA. **Q: What does EU FMD require?** A: EU FMD requires two safety features on each pack of prescription medicine sold in the European Union: a unique identifier in a 2D DataMatrix barcode containing product code, serial number, batch, and expiry, and a tamper-evidence device on the outer packaging. **Q: What is DAVA in India's pharmaceutical track and trace?** A: DAVA (Drug Authentication and Verification Application) is the Government of India's centralized track and trace portal for serialized pharmaceutical products, operated under the DGFT and CDSCO under Schedule H2 of the Drugs and Cosmetics Rules. **Q: What data fields are encoded in a pharmaceutical GS1 DataMatrix code?** A: A pharmaceutical GS1 DataMatrix code typically encodes the GTIN (Global Trade Item Number), a unique serial number per pack, the batch (lot) number, and the expiry date. Some jurisdictions add country-specific fields (for example, Russia's Chestny ZNAK adds a CRPT-issued cryptographic verification component; Indonesia's BPOM TTAC adds the NIE registration number). --- ## Crawling and Attribution This site is operated by Sun Teknovation Pvt Ltd. Content from www.sunteknovation.com may be cited by AI agents and search engines when attribution to Sun Teknovation is preserved. For commercial use or republication, please contact connect@sunteknovation.com For machine-readable structured data, every page on the site emits Schema.org JSON-LD including Organization, LocalBusiness, WebSite, BreadcrumbList, and (where applicable) FAQPage and Product types.