Suppliers and packagers for TLANDO

TLANDO

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Verity	TLANDO	testosterone undecanoate	CAPSULE;ORAL	208088	NDA	Antares Pharma, Inc.	54436-112-20	120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (54436-112-20)	2022-04-15
Verity	TLANDO	testosterone undecanoate	CAPSULE;ORAL	208088	NDA	Verity Pharmaceuticals Inc.	74676-0112-2	120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (74676-0112-2)	2022-04-15

Suppliers for the Pharmaceutical Drug: Tlando

Last updated: July 27, 2025

Introduction

Tlando, marketed as a testosterone transdermal patch, represents a significant advancement in hormone replacement therapy (HRT) for males with low testosterone levels. As a novel therapeutic, its supply chain influences access, pricing, and availability. This article analyzes the key suppliers involved in manufacturing, distributing, and providing Tlando globally, considering strategic importance, regulatory hurdles, and market dynamics.

Overview of Tlando and its Manufacturing Landscape

Tlando (testosterone transdermal) is developed by Antares Pharma, a biotech firm specializing in topical and injectable drug delivery systems. Unlike traditional testosterone formulations, Tlando leverages a transdermal patch platform to provide consistent hormone levels, enhancing patient compliance and therapeutic outcomes (1).

Given the proprietary nature of its delivery mechanism, the supply chain encompasses raw material providers, contract manufacturers, and distribution channels. Their integration affects the product’s availability across markets.

Raw Material Suppliers

The production of Tlando's transdermal patches depends on high-grade pharmaceutical-grade materials. Key raw materials include:

• Adhesive Components: Medical-grade adhesives resilient to skin contact and capable of delivering consistent drug doses. Suppliers such as 3M, Dow Corning, and Lohmann Therapy offer specialized adhesives used in transdermal drug patches.

• Active Pharmaceutical Ingredient (API): Testosterone base or esters, which are sourced from established chemical manufacturers such as Lonza, Thermo Fisher Scientific, or PVL (Purevax Labs). These companies supply pharmaceutical-grade testosterone that meets stringent regulatory criteria (2).

• Backing Layers and Films: Polymer films and backing layers are often sourced from international suppliers like Evonik or Arkema, providing films with optimal permeability and durability.

Regulatory note: Raw materials must comply with pharmacopoeial standards (USP, EP, or JP), ensuring safety and efficacy.

Contract Manufacturing and Packaging

Antares Pharma partners with contract manufacturing organizations (CMOs) to produce Tlando at scale. Among the notable CMOs are:

• Catalent: Known for its advanced transdermal drug formulation facilities, Catalent supplies manufacturing, stability testing, and packaging services (3).

• Recipharm & Fareva: These companies also serve as CMOs, offering scalable production based on regulatory compliance.

Antares maintains rigorous quality controls, often outsourcing manufacturing to facilities certified with ISO 13485, cGMP, and other relevant certifications.

Distribution Channels

The finished Tlando product reaches patients through a combination of wholesale distributors, specialty pharmacies, and hospital supply chains. Major pharmaceutical distributors like McKesson, AmerisourceBergen, and Cardinal Health serve as primary channels for distribution across North America.

Global markets require localization strategies, including partnerships with regional distributors and government tender systems, especially in Europe and Asia.

Key Suppliers and Their Strategic Roles

Supplier Category	Notable Companies	Strategic Importance
Raw Material Suppliers	3M, Dow Corning, Lohmann, Lonza, Thermo Fisher	Foundational for product quality and raw material integrity
Contract Manufacturers	Catalent, Recipharm, Fareva	Ensure scalable, compliant manufacturing
Distribution & Logistics	McKesson, AmerisourceBergen, Cardinal Health	Critical in timely, compliant product delivery

Regulatory and Supply Chain Challenges

The complexities of patent protections, regulatory approvals, and global trade restrictions influence supplier choices and sourcing strategies. For instance, testosterone APIs must meet strict purity standards, and modifications to manufacturing processes require regulatory re-approvals (4).

Moreover, COVID-19 highlighted vulnerabilities in the supply chain, emphasizing the importance of diversified sourcing and contingency planning.

Strategic Implications for Stakeholders

• Prominent players like Antares Pharma depend on established raw material providers and trusted CMOs to secure supply continuity.
• Market expansion into emerging economies necessitates collaboration with local distributors and adherence to regional regulatory standards.
• Intellectual property rights influence branding and supplier negotiations, particularly concerning proprietary delivery systems.

Future Outlook

Moving forward, the supply chain for Tlando is poised to evolve with innovations such as bioengineered raw materials, sustainable manufacturing practices, and localized supply networks. Additionally, patent expirations for testosterone APIs could open opportunities for new suppliers to enter the space, potentially reducing costs and increasing accessibility.

Key Takeaways

• The supply chain for Tlando involves a tightly integrated network of high-quality raw material suppliers, OEM manufacturers, and distribution channels.
• Ensuring compliance with regulatory standards across all suppliers is pivotal for maintaining product integrity and market access.
• Diversification of suppliers and manufacturing sites enhances resilience against disruptions, exemplified during the COVID-19 crisis.
• Strategic partnerships with CMOs like Catalent and robust logistics providers underpin timely product availability.
• The ongoing evolution of raw materials and manufacturing technologies will shape the future landscape, impacting pricing, innovation, and market penetration.

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FAQs

1. Who are the main raw material suppliers for Tlando?
Major raw material suppliers include companies like 3M and Dow Corning for adhesives, Lonza and Thermo Fisher Scientific for testosterone API, and Evonik for backing films. These suppliers provide high-purity, pharmaceutical-grade components essential for product safety and efficacy (1,2).

2. Which contract manufacturers produce Tlando?
Catalent and other CMOs such as Recipharm and Fareva manufacture Tlando, leveraging specialized expertise in transdermal delivery systems to ensure high-quality, scalable production compliant with cGMP standards (3).

3. Are there regional differences in Tlando's supply chain?
Yes. While North American distribution heavily relies on large wholesalers like McKesson, European and Asian markets depend on local distributors and regulatory approvals, requiring tailored supply partnerships (4).

4. How do supply chain disruptions affect Tlando availability?
Disruptions can delay raw material shipments, manufacturing, or distribution, impacting product availability. Diversification and contingency planning are critical to mitigate risks, as seen during the pandemic (4).

5. What trends could impact Tlando’s supply chain in the future?
Emerging technologies in bioengineering, sustainable materials, and regional manufacturing may diversify and strengthen the supply chain. Patent expirations could also introduce new suppliers, affecting market competition and pricing dynamics.

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References

1. Antares Pharma. "Tlando (testosterone transdermal system): Overview." [Company Website]

2. USP Pharmacopoeia. "Testosterone Raw Materials Standards." 2022.

3. Catalent. "Manufacturing Capabilities." [Company Website]

4. World Health Organization. “Global supply chain guidelines for pharmaceuticals.” 2021.