Asas Label
Industry

Pharmaceuticals

Regulatory-compliant pharmaceutical labels with serialization, tamper-evident features, and multi-layer solutions. FDA, MOHAP, DHA, SFDA certified.

Pharmaceuticals
Built to support
MOHAP / DHA / SFDA
UAE and Saudi regulatory submission standards
FDA / EU
International market compliance
ISO 15378
Primary packaging materials for medicinal products
UDI / GS1-128
Serialisation and Data Matrix with inline verification

We manufacture labels to support your compliance with these standards. Final artwork approval and regulatory responsibility rest with the product owner.

Pharmaceutical Manufacturers Trust ASAS Label
01

Pharmaceutical Manufacturers Trust ASAS Label

  • Multi-Jurisdiction Compliance

    FDA, MOHAP, DHA, SFDA, and EU standards across UAE, GCC, and international markets

  • Track & Trace Serialization

    UDI, Data Matrix, GS1-128 barcodes with 100% inline verification

  • Multi-Layer Solutions

    Booklet labels, peel & reseal, fold-out for extended content and PILs

  • Anti-Counterfeiting

    Tamper-evident features, holographic elements, and security patterns

02

Regulatory Compliance Across Multiple Jurisdictions

Pharmaceutical labeling is governed by complex, overlapping regulations. Our production processes and material specifications align with regulatory requirements across UAE, GCC, and international markets.

UAE & GCC

UAE & GCC

Ministry of Health & Prevention (MOHAP) - UAE standards

  • Dubai Health Authority (DHA) - Medication packaging
  • Saudi Food & Drug Authority (SFDA) - Import compliance
  • GCC Standardization Organization (GSO) - Unified standards
International

International

FDA 21 CFR Part 201 - Prescription drug labeling

  • FDA 21 CFR Part 101 - OTC drug and supplement facts
  • EU Directive 2001/83/EC - Medicinal products
  • ICH Q7 - Good Manufacturing Practice guidelines
  • ISO 15378 - Primary packaging materials
03

Pharmaceutical Label Applications

From prescription medications to clinical trials, our pharmaceutical labels ensure patient safety, regulatory compliance, and supply chain integrity across diverse healthcare applications.

  • Prescription medication bottles & containers
  • Injectable & parenteral product vials
  • Over-the-counter drugs & supplements
  • Medical device identification labels
  • Clinical trial & investigational products
  • Pharmaceutical blister packs
  • IV bags & infusion solutions
  • Syringe & ampoule labels
Pharmaceutical Label Applications
04

Track-and-Trace Capabilities

Unique Device Identification (UDI)
01 / 06

Unique Device Identification (UDI)

FDA and EUDAMED compliant

05

Multi-Layer & Extended Content Labels

When package size limits available label space, our multi-layer solutions provide the real estate needed for comprehensive pharmaceutical information and Patient Information Leaflets (PILs).

Booklet Labels

Booklet Labels

2-ply to 8-ply configurations, up to 80 pages content area

  • Multilingual PILs
  • Resealable adhesive
  • Automated application compatible
Peel & Reseal

Peel & Reseal

Dual-layer with repositionable top layer

  • Clinical trial instructions
  • Tamper-evidence
  • Variable data capable
Fold-Out Labels

Fold-Out Labels

Extended panels folded accordion-style

  • Up to 370mm extended
  • Multi-language regulatory text
  • Compact footprint
06

Substrate Explorer

Pick a symbol to see each substrate’s specifications, strengths and where it fits.

Substrates

PP01 / 08

Clear Polypropylene (PP)

Moisture barrier, 'no label' appearance for solution vials

07

Specialized Adhesive Systems

Critical adhesive performance for pharmaceutical applications including extreme temperatures, sterilization, and chemical exposure

Permanent Acrylic

Long-term aging, minimal yellowing, clean die-cutting

Permanent Rubber

Immediate tack, cold temperature performance

High-Tack

Low surface energy plastics (HDPE, PP bottles)

Removable

Clinical trials, clean removal without residue

Ultra-Low Temperature

Frozen storage (-40°C to -80°C)

Autoclave Resistant

Withstands steam sterilization

Gamma Radiation

Terminal sterilization compatibility

08

Tamper-Evident & Anti-Counterfeiting

Protect pharmaceutical products with advanced security features including tamper-evident seals, holographic elements, and serialization capabilities to ensure product integrity and patient safety.

  • Void Patterns: Destructible materials that reveal "VOID" when removal is attempted
  • Holographic Features: Diffractive optical elements for brand protection
  • Unique Serialization: Track & trace compliance with database integration
  • QR Authentication: Consumer verification via smartphone scanning
09

Quality Assurance & Compliance

Every pharmaceutical label undergoes rigorous testing and validation to meet industry standards for patient safety and regulatory compliance.

Regulatory Documentation
01 / 04

Regulatory Documentation

Complete material safety data, migration certificates, and compliance declarations

FAQ

Frequently Asked Questions

Which regulations do your pharmaceutical labels support?

FDA 21 CFR Part 201 for prescription drug labelling and Part 101 for OTC and supplement facts, EU Directive 2001/83/EC, ISO 15378 for primary packaging materials, ICH Q7 GMP guidance, plus MOHAP, Dubai Health Authority, SFDA and GSO standards across the UAE and GCC.

Can you do serialisation and track-and-trace?

Yes. We produce Unique Device Identification (UDI) that is FDA and EUDAMED compliant, GS1 standard serialisation, Data Matrix and GS1-128 barcodes, QR codes for patient information and authentication, and lot numbering — with 100% inline vision inspection on every serialised label.

How do we fit multi-language patient information on a small vial?

Multi-layer and extended-content labels expand to carry the full leaflet content, up to 370mm extended, without changing the container.

What anti-counterfeiting options do you offer?

Tamper-evident features, holographic elements and security patterns, which is what the sector uses to protect supply-chain integrity.

24-hour response

Request a quote for Pharmaceuticals

Tell us your label specs — type, size, material, quantity — and our sales team will reply with a detailed quote.