Business industrial

Eli Lilly’s Alzheimer’s Drug Wins Backing of US Advisory Panel

Published

2 years ago

June 10, 2024

Harry Williams

Reviewed
By Mike Henery

Eli Lilly, a global pharmaceutical company, has made a significant breakthrough in the fight against Alzheimer’s disease. Their new drug, donanemab, has recently received backing from a U.S. advisory panel, marking a pivotal moment in the treatment of this debilitating condition. This article explores the implications of this endorsement, the drug’s mechanism of action, the results of clinical trials, and its potential impact on patients and the healthcare system. Additionally, we will provide an analysis table summarizing key points and a comparative table evaluating donanemab against other Alzheimer’s treatments.

The Significance of Alzheimer’s Disease

FILE – A sign for Eli Lilly & Co. sits outside their corporate headquarters in Indianapolis on April 26, 2017. A closely watched Alzheimer’s drug from Eli Lilly won the backing of federal health advisers on Monday, June 10, 2024, setting the stage for the treatment’s expected approval for people with mild dementia caused by the brain-robbing disease. (AP Photo/Darron Cummings, File)

Alzheimer’s disease is a progressive neurological disorder that leads to memory loss, cognitive decline, and ultimately, loss of ability to carry out simple tasks. Affecting millions of individuals worldwide, Alzheimer’s is the most common form of dementia, posing a major public health challenge. As the population ages, the prevalence of Alzheimer’s is expected to rise, making effective treatments more critical than ever.

Overview of Donanemab

Mechanism of Action

Donanemab is a monoclonal antibody designed to target amyloid-beta plaques in the brain, a hallmark of Alzheimer’s disease. These plaques are believed to play a crucial role in the disease’s progression by disrupting cell function and triggering inflammation. By binding to and facilitating the removal of these plaques, donanemab aims to slow cognitive decline and improve patient outcomes.

Clinical Trials and Efficacy

Eli Lilly conducted several clinical trials to evaluate the safety and efficacy of donanemab. The most notable among these is the TRAILBLAZER-ALZ trial, which demonstrated that patients receiving donanemab experienced a significant slowing of cognitive decline compared to those on placebo. These results have generated optimism about the drug’s potential to alter the course of Alzheimer’s disease.

Safety Profile

The safety profile of donanemab has been closely monitored throughout its clinical development. While some patients experienced side effects such as amyloid-related imaging abnormalities (ARIA), the majority of these were manageable and did not outweigh the drug’s benefits. The advisory panel’s endorsement indicates confidence in the overall safety and efficacy of donanemab.

Advisory Panel Endorsement

Decision-Making Process

The U.S. advisory panel’s decision to back donanemab was based on a thorough review of clinical trial data, including efficacy and safety outcomes. The panel, consisting of experts in neurology, geriatrics, and pharmacology, weighed the benefits of slowing cognitive decline against the potential risks associated with the drug. Their endorsement reflects a consensus that donanemab offers a meaningful advancement in Alzheimer’s treatment.

Implications for FDA Approval

While the advisory panel’s backing is a positive step, final approval from the U.S. Food and Drug Administration (FDA) is still required before donanemab can be marketed. The FDA typically follows the advisory panel’s recommendations, but it conducts its own independent review. Approval would pave the way for donanemab to become available to patients, potentially transforming the landscape of Alzheimer’s care.

Comparative Analysis of Alzheimer’s Treatments

Current Standard of Care

The current standard of care for Alzheimer’s disease includes cholinesterase inhibitors (donepezil, rivastigmine, and galantamine) and the NMDA receptor antagonist memantine. These drugs offer symptomatic relief but do not address the underlying pathology of the disease.

Donanemab vs. Other Disease-Modifying Therapies

In recent years, other disease-modifying therapies, such as aducanumab and lecanemab, have also emerged. These drugs, like donanemab, target amyloid-beta plaques but have shown varying degrees of efficacy and safety profiles.

Analysis Table

Aspect	Donanemab	Current Standard of Care (Cholinesterase Inhibitors, Memantine)	Aducanumab	Lecanemab
Mechanism of Action	Targets amyloid-beta plaques	Inhibits breakdown of acetylcholine; NMDA receptor antagonism	Targets amyloid-beta plaques	Targets amyloid-beta plaques
Efficacy	Slows cognitive decline	Provides symptomatic relief	Reduces amyloid plaques	Slows cognitive decline
Safety	Manageable side effects (ARIA)	Generally well-tolerated; side effects vary	ARIA	ARIA
Approval Status	Awaiting FDA approval	FDA approved	FDA approved	FDA approved
Clinical Trials	TRAILBLAZER-ALZ	Multiple studies	EMERGE, ENGAGE	CLARITY AD, AHEAD 3-45

Potential Impact on Patients and Healthcare System

Improved Patient Outcomes

If approved, donanemab could offer significant benefits for patients with Alzheimer’s disease. By slowing cognitive decline, the drug has the potential to prolong patients’ independence and improve their quality of life. Early intervention with donanemab could delay the progression of symptoms, allowing patients to maintain their cognitive functions for a longer period.

Economic Implications

The introduction of donanemab could also have substantial economic implications. Alzheimer’s disease places a heavy financial burden on healthcare systems, caregivers, and society as a whole. Effective disease-modifying treatments like donanemab could reduce the need for extensive caregiving and long-term care, potentially leading to cost savings.

Ethical Considerations

The approval and widespread use of donanemab also raise ethical considerations. Issues related to access, affordability, and equity must be addressed to ensure that all patients who could benefit from the drug have the opportunity to receive it. Policymakers and healthcare providers will need to work together to navigate these challenges.

Comparative Table

Feature	Donanemab	Current Standard of Care	Aducanumab	Lecanemab
Drug Class	Monoclonal antibody	Cholinesterase inhibitors, NMDA antagonist	Monoclonal antibody	Monoclonal antibody
Target	Amyloid-beta plaques	Acetylcholine breakdown, NMDA receptor	Amyloid-beta plaques	Amyloid-beta plaques
Primary Benefit	Slows cognitive decline	Symptomatic relief	Reduces amyloid plaques	Slows cognitive decline
Common Side Effects	ARIA, headache, nausea	Nausea, vomiting, diarrhea, dizziness	ARIA, headache	ARIA, headache
Administration	Intravenous infusion	Oral tablets	Intravenous infusion	Intravenous infusion
Clinical Trial Highlights	TRAILBLAZER-ALZ	Various	EMERGE, ENGAGE	CLARITY AD, AHEAD 3-45
Regulatory Status	Awaiting FDA approval	FDA approved	FDA approved	FDA approved
Potential Cost	High	Moderate	High	High
Accessibility	Pending approval	Widely available	Limited due to cost and access	Limited due to cost and access

Future Directions

The development and potential approval of donanemab underscore the ongoing innovation in Alzheimer’s research. Continued investment in understanding the disease’s mechanisms and developing effective treatments is essential. Future research may explore combination therapies, biomarkers for early detection, and strategies to enhance the drug’s efficacy and safety.

The journey towards a cure for Alzheimer’s is far from over, but each advancement brings new hope. Donanemab’s progress represents a significant step forward, demonstrating the importance of scientific perseverance and the promise of emerging therapies in changing the trajectory of Alzheimer’s disease.

Conclusion

Eli Lilly’s donanemab represents a Advisory promising advancement in the treatment of Alzheimer’s disease. The backing of the U.S. advisory panel highlights the drug’s potential to slow cognitive decline and improve patient outcomes. As the healthcare community awaits FDA approval, the hope is that donanemab will soon become a valuable tool in the fight against Alzheimer’s, offering new hope to patients and their families.

Author

Harry Williams

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Business

Guide to Choosing the Right OEM Partner for Your Business

Published

2 days ago

January 20, 2026

jindallifestyle

Selecting the right Original Equipment Manufacturer (OEM) is crucial for any business aiming to ensure product excellence, enhance operational efficiency, uphold brand reputation, and achieve sustainable growth.

For companies that are looking to expand their reach, reduce manufacturing costs, or innovate, an OEM partnership transcends the traditional supplier relationship—it grows into a long-term collaboration centered on trust, capability, and reliability.

With a multitude of OEM manufacturers in India and around the world, identifying the ideal partner can be a daunting task. By asking the right questions early in the evaluation process, businesses can steer clear of expensive pitfalls and align their operations with strategic long-term goals.

Here’s a guide highlighting seven pivotal questions to consider when choosing an OEM partner, along with why these questions are essential and how a trusted partner like Jindal Lifestyle can help you achieve your manufacturing ambitions.

1. Does the OEM Partner Have Proven Industry Experience?

The first indicator of a dependable OEM partner is their experience in the industry. An established manufacturer is familiar with industry standards, regulatory requirements, and the challenges of production that may elude less seasoned players.

Why This Matters:

An experienced partner offers the ability to:

Anticipate potential production challenges.
Maintain consistency across substantial orders.
Adapt swiftly to shifting market demands.

When assessing experience, consider not only the number of years in business but also the diversity of industries served, the complexity of previous projects, and the types of products they have handled.

2. What Manufacturing Capabilities and Infrastructure Do They Offer?

The manufacturing capabilities of an OEM determine what they can deliver now and in the future. Modern production requires sophisticated machinery, skilled labor, and scalable operations to keep pace with growing demand.

Key Aspects to Evaluate:

In-house versus outsourced manufacturing.
Availability of advanced equipment and tooling.
Production capacity and scalability.
Capability to manage both bulk and specialized orders.

A well-equipped OEM partner guarantees operational control, quicker turnaround times, and consistent quality across product batches.

Why This Matters:

Inadequate infrastructure can lead to production delays, inconsistent quality, and reliance on third-party suppliers, all of which can jeopardize timelines and product quality.

3. How Robust Are Their Quality Control and Compliance Standards?

Quality assurance is critical in OEM manufacturing. The processes your partner employs for quality control significantly impact your brand’s reputation in the marketplace.

Key Quality Indicators:

Established quality control procedures.
Adherence to national and international compliance standards.
Regular testing and inspection procedures.
Clear documentation and traceability.

Why This Matters:

Inconsistencies in quality can result in customer dissatisfaction, increased product returns, and long-term damage to your brand’s credibility.

4. Can the OEM Partner Accommodate Customization and Design Needs?

In today’s competitive landscape, customization can set a brand apart. Your OEM partner should be able to transform design concepts into practical, manufacturable products without compromising on quality or cost.

Evaluate Their Offerings:

Design collaboration and expert input.
Prototyping and sampling assistance.
Flexibility in materials and finishes.
Engineering support for intricate designs.

Why This Matters:

An OEM partner familiar with both design intent and manufacturing feasibility can streamline development cycles and reduce costs effectively.

5. How Dependable Are Their Delivery Timelines and Supply Chain Processes?

Timeliness is crucial for businesses in fast-paced or seasonal markets. Production delays can disrupt inventory management, sales cycles, and customer satisfaction.

Assess the OEM’s Capacity:

Production planning and scheduling.
Reliability of raw material sourcing.
Logistics and shipping capabilities.
Track record in meeting delivery deadlines.

Why This Matters:

Unreliable delivery times can lead to missed opportunities, increased inventory costs, and strained relationships with customers.

6. Is Their Pricing Structure Clear and Transparent?

Transparency fosters trust in any OEM relationship. Hidden costs or unclear pricing can lead to frustrations and long-term dissatisfaction.

What to Look For:

Detailed cost breakdowns.
Pricing that reflects both quality and order volume.
Regular communication during the production process.
Responsiveness to inquiries and feedback.

Why This Matters:

Clear communication leads to smoother operations, better cost management, and quicker resolutions to any issues that arise.

7. Does the OEM Partner Focus on Long-Term Relationships and Growth?

OEM partnerships thrive when they are viewed as long-term collaborations rather than one-time transactions. A partner invested in your growth continually seeks ways to improve, innovate, and expand their capacity to meet your needs.

Signs of a Growth-Oriented Partner:

Willingness to scale operations as your business grows.
Commitment to investing in new technologies and processes.
Prioritization of long-term cooperation over immediate profits.
Provision of ongoing support after production.

Why This Matters:

A long-term OEM partner essentially becomes an extension of your business, contributing to stability and long-lasting growth.

Why Jindal Lifestyle Is a Trusted OEM Partner in India

When considering OEM partners, companies prioritize reliability, quality, and consistency. Jindal Lifestyle sets itself apart by merging cutting-edge manufacturing capabilities with a commitment to craftsmanship and innovation.

Key Advantages Include:

Extensive experience in stainless steel manufacturing.
Modern facilities designed for scalable production.
Strict compliance and quality standards.
Expertise in customized manufacturing solutions.
Reliable timelines and clear communication processes.

These strengths make Jindal Lifestyle a favored OEM partner for businesses that seek enduring quality and operational excellence.

Conclusion

Choosing the right OEM partner can significantly influence a business’s success, brand image, and operational efficiency. By asking the right questions about industry experience, capabilities, quality standards, customization options, delivery reliability, pricing transparency, and commitment to partnership, businesses can make informed decisions and form resilient manufacturing partnerships.

For organizations looking for a dependable, quality-focused OEM partner in India, Jindal Lifestyle offers the necessary expertise, advanced infrastructure, and commitment to support sustainable growth.

Author

jindallifestyle

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Business

Understanding Construction Submittals: Types and Importance

Published

1 week ago

January 15, 2026

houseura

Submittals are extremely important in the construction business, as they help ensure that a project is carried out according to the design intent, specifications, and quality standards. Furthermore, submittals serve as the communication medium between contractors, architects, engineers, and clients, whether it involves materials, equipment, shop drawings, or samples, among others.

In addition to their communication role, being aware of the different types of submittals involved is key to efficient project management. By doing so, you can minimize mistakes and facilitate timely approvals. Therefore, this blog will discuss what submittals are, their importance, and the key forms of submittals that are commonly applied in construction projects.

What are Submittals in Construction?

The submittals are reports, samples or data files that are sent by contractors to design professionals to be reviewed and approved in advance prior to installation or implementation. They ensure that the materials, products or methods proposed are as per the specifications of a project.

Submittals do not alter the design of the contract, but rather they verify the conformity and prevent the expensive rework, delays, and disputes.

What Is the Impact of Submittals?

Submittals are necessary because of a number of reasons:

Make sure that materials are as specified in the project.
Enforce quality and regularity.
Enhance co-ordination among teams on the project.
Reduce construction errors
Give records to be used later.
Promote on-time checks and sanctions.

Even the well-intended projects may experience critical implementation Radar without a due process of submittal.

Biggest Construction Submittals

Submittals have a number of types that are implemented within a construction project. They have a purpose and a stage of work.

1. Shop Drawings Submittals

Shop drawings are elaborate drawings that are made by contractors, suppliers or manufacturers. They demonstrate the manner in which certain parts are going to be manufactured, assembled, or put together.

Key Features:

Add dimensions, materials and installation specifications.
More elaborate than design drawings.
Coordination and clash detection.

Examples:

Structural steel drawings
HVAC duct layouts
Electrical panel layouts
Plumbing system drawings

Shop drawings assist in the elimination of wrong fitting components in a general design.

2. Product Data Submittals

Product data submittals entails manufacturer information on products that are being suggested to be used in the project.

Key Features:

Manufacturer specifications
Performance data
Installation instructions
Warranty details

Examples:

Doors and windows
Lighting fixtures
HVAC units
Fire protection systems

These submissions make sure that the products chosen are within the specifications that are required by the contract documentation both in terms of specifications and performance.

3. Material Submittals

Material submittals are concerned with the materials that were utilized in the construction and their characteristics.

Key Features:

Material composition
Data on strength and durability.
Standards (ASTM, IS, ISO) compliance.

Examples:

Concrete mix designs
Steel grades
Roofing materials
Flooring materials

Submittal of materials is essential to safety, durability and long performance.

4. Sample Submittals

Sample submittals entail the submission of physical samples to be reviewed and approved to ensure that they appear and are of quality.

Key Features:

Pay attention to color, texture and finish.
Used for visual approval
It is often kept as a project standard.

Examples:

Tiles and stones
Paint colors
Carpets and fabrics
Brick and masonry units

On approval, samples are the standard to all work installed.

5. Mock-Up Submittals

Mock-ups are complete or incomplete models of an element or system.

Key Features:

Show the quality of workmanship.
Create the possibility of early detection of problems.
Improve client confidence

Examples:

Wall assemblies
Bathroom mock-ups
Façade systems

In high-end or complicated projects, mock-ups can be of great use.

6. Test and Inspection Reports

The submittals of these are tests of performance and testing of compliance.

Key Features:

By certified laboratories or inspectors.
At various construction phases, they are required.
Friendly to approvals.

Examples:

Reports of concrete tests of strength.
Soil compaction reports
Fire safety test results
Reports on water pressure testing.

Test reports provide the assurance that the project is of a quality and safe nature.

7. Method Statement Submittals.

Method statements are used to explain how certain construction activities are to be completed.

Key Features:

Staged implementation of the project.
Safety measures
Machinery and labor specifications.

Examples:

Excavation methodology
Pouring concrete operations.
Waterproofing methods of application.

These submissions contribute to the mitigation of risk and safety of the site.

8. As-Built Drawings Submittals.

As-built drawings indicate the true conditions of the construction at the time when the project is finished.

Key Features:

Display installed final positions.
Incorporate authorized changes and deviations.
To maintain and then renovate in the future.

Examples:

Electrical wiring layouts
Plumbing routing
Structural modifications

As-built drawings are important to facility management.

9. Step-by-Step Visual (Operation and maintenance) Manuals.

Long-term operation guidelines are provided by O&M manuals which are submitted around the time of completion of the project.

Key Features:

Instruction of equipment operation.
Maintenance schedules
Warranty information

Examples:

HVAC system manuals
Elevators and escalators
Fire alarm systems

These manuals facilitate efficient maintenance of systems by the owners.

Best Practices in Submittals control

In order to have an effective submittal:

Prepare a comprehensive submittal log.
Adhere to the project submittal pattern.
Use standardized templates
Endorse track amendments and approvals.
Keep in touch with the stakeholders.

Quality and timelines of the projects directly rely on the efficient submittal management.

Conclusion

It is also compulsory to understand the types of submittals as an individual in construction projects. Shop drawings and product data, samples and as-built drawings are just but a few of the types of submittals, as each is critical to quality, compliance, and coordination.

An effectively managed submittal process will lower the mistakes, enhance teamwork, and deliver the project in a successful manner. Being a contractor, architect, engineer, or project manager, learning how to do submittals is one of the steps that would lead to excellence in construction.

Author

houseura

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Business

Transform Your Brand with Custom CBD Packaging Solutions

Published

1 week ago

January 14, 2026

Packagingunit

In the rapidly expanding CBD and cannabis industry, packaging has evolved beyond mere protection. It has become a vital component of your brand identity. With more businesses entering this competitive market, creating a memorable customer experience and standing out on retail shelves is essential. This is where Packaging Unit excels, offering high-quality custom CBD boxes and tailored packaging solutions that meet diverse needs.

From sustainable materials to luxurious finishes, Packaging Unit empowers brands of all sizes to create packaging that is both functional and visually striking, while also adhering to industry regulations. In this article, we’ll delve into the significance of custom CBD packaging, the range of materials available, various finishing options, and the importance of choosing the right packaging partner to enhance your brand’s presence.

The Importance of Packaging in the CBD Industry

The CBD market is on a continuous growth trajectory, and consumer expectations are evolving just as rapidly. Whether your products include oils, gummies, tinctures, pre-rolls, or wellness items, your packaging must fulfill several crucial roles:

Product Protection: It should keep the product in optimal condition.
Brand Communication: Packaging must effectively convey your brand story and values.
Regulatory Compliance: Adhering to industry rules is a must.
Competition Differentiation: Your packaging should help you stand out from competitors.
User Experience Enhancement: A premium feel can enhance customer satisfaction.

The first physical interaction customers have with your product occurs through the packaging, influencing their perceptions of quality, trust, and value. With custom CBD boxes from Packaging Unit, brands can ensure every touchpoint reflects professionalism and consistency.

Custom CBD Boxes Tailored to Your Vision

Packaging Unit specializes in creating fully customizable packaging tailored to your unique brand needs. Their custom boxes are crafted from high-quality cardstock, available in various thicknesses, finishes, and styles.

Popular Material Options Include:

14PT, 16PT, and 18PT Cover Stock: Durable options that are perfect for vibrant printing.
130# Uncoated Cover: Ideal for a natural or earthy aesthetic.
130# Epic Black Smooth or Linen: Striking options for high-end items
Metalized Stock: High-end material that catches the eye.
Brown Kraft: An eco-friendly choice suitable for sustainable brands.

These materials allow businesses to create packaging that reflects their aesthetic, whether minimalistic, elegant, or artisanal.

Crafting Durable and Eye-Catching Cannabis Packaging

CBD and cannabis products often require robust protection against light, moisture, and external damage. Packaging Unit designs every box to safeguard product quality while enhancing visual appeal.

Their custom cannabis packaging is engineered for durability, providing protection for a variety of products, including:

Tincture bottles
Vape cartridges
Pre-rolls
Concentrates
Gummies and edibles
Topical creams
Capsules and supplements

By selecting the right thickness and structural design, your packaging can help extend the product’s shelf life and maintain integrity.

Premium Finishing Options for a Polished Look

One of the standout features of Packaging Unit is its diverse range of finishing options, enhancing your packaging design both in beauty and strength.

Finishing Options Include:

Gloss Lamination: Provides a sleek, shiny finish and increased durability.
Matte Lamination: Offers a modern, non-reflective appearance.
Soft Touch Lamination: Delivers a luxurious, velvety feel.
UV Coating: Adds high-gloss protection and enhances color vibrancy.
Linen Texture: Introduces a unique, elegant surface.
Holographic Lamination: Creates a striking, iridescent effect that makes products pop.

These premium finishes help your packaging to stand out, especially in a crowded market.

Luxury Features for High-End Branding

For brands aiming for a refined image, Packaging Unit offers luxury enhancements that elevate perceived value.

Available Luxury Add-Ons:

Gold, Silver, and Copper Foiling
Rose Gold Foiling
Holographic Foil
Spot UV (Raised or Standard)
Embossing and Debossing
Window Cut-Outs
Die-Cutting for Custom Shapes

These features add depth and elegance, making them ideal for brands targeting premium customers.

Why Partner with Packaging Unit?

Packaging Unit distinguishes itself as a trusted partner for both new and established CBD brands. Here’s what sets them apart:

Industry Expertise: Their team understands the intricate guidelines and presentation standards for CBD and cannabis packaging.
Free Design Support: If you lack ready-made designs, Packaging Unit offers templates and expert guidance to create print-optimized artwork.
Compliance Ready: They ensure your packaging adheres to regulatory requirements, a vital step in this sector.
Cost and Time Efficiency: Fast production and competitive pricing streamline the journey from concept to delivery.
Exceptional Printing Quality: Utilizing advanced printing technology guarantees sharp graphics and vibrant colors.
Flexible Customization: Each box is made to order, allowing you to choose dimensions, materials, colors, finishes, and add-ons that accurately represent your brand identity.

Custom CBD Boxes Wholesale Options

For brands looking to scale up, Packaging Unit offers wholesale pricing on bulk orders. Advantages of bulk purchasing include:

Better cost savings
Consistent packaging across product lines
Quicker restocking processes
Improved profit margins

Whether you’re launching a new CBD line or expanding existing offerings, wholesale custom CBD packaging helps you stay consistent while being cost-effective.

A Streamlined Four-Step Process

Packaging Unit simplifies the production process with four easy steps:

Consultation: Share details about your products, requirements, and design preferences.
The team will lead you to the optimal choices
Design Finalization: Submit your artwork for review or collaborate with their designers for the perfect box layout.
Production: Once approved, boxes enter production using high-quality materials and advanced printing techniques.
Delivery: Your custom boxes arrive promptly, fully secured and ready for use.

Make Your Brand Stand Out

Your packaging is often the first impression you make on potential buyers, significantly impacting their decision to purchase. In a competitive market where many brands vie for attention, investing in high-quality custom cannabis packaging is crucial.

Packaging Unit ensures that your packaging:

Reflects your brand identity
Protects your product
Enhances the customer experience
Meets compliance requirements
Drives repeat sales
Creates social media-worthy unboxing moments

Whether you seek eco-friendly materials, luxurious finishing touches, or bold designs, Packaging Unit customizes everything to fit your vision.

Conclusion

As the CBD industry continues to thrive, prioritizing packaging as a key differentiator is vital for brands. With Packaging Unit’s expertise, cutting-edge printing technology, and extensive customization options, creating impactful custom CBD boxes becomes a seamless process.

Your packaging is more than just a container; it embodies your story, your identity, and your opportunity to leave a lasting impression. When you’re ready to elevate your CBD products and compete effectively in the market, Packaging Unit stands ready to be your partner in superior custom cannabis packaging solutions.