Suppliers and packagers for TWIRLA

TWIRLA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Agile	TWIRLA	ethinyl estradiol; levonorgestrel	SYSTEM;TRANSDERMAL	204017	NDA	Agile Therapeutics, Inc.	71671-100-01	1 POUCH in 1 CARTON (71671-100-01) / 1 PATCH in 1 POUCH (71671-100-11)	2020-09-11
Agile	TWIRLA	ethinyl estradiol; levonorgestrel	SYSTEM;TRANSDERMAL	204017	NDA	Agile Therapeutics, Inc.	71671-100-03	3 POUCH in 1 CARTON (71671-100-03) / 1 PATCH in 1 POUCH (71671-100-11)	2020-09-11

Suppliers for the Pharmaceutical Drug: TWIRLA

Last updated: July 29, 2025

Introduction

TWIRLA is a prescription transdermal contraceptive patch formulated to deliver consistent hormone levels for pregnancy prevention in women. Marketed by Allergan (a landmark acquisition by AbbVie in 2020), TWIRLA’s manufacturing relies on a complex supply chain, encompassing active pharmaceutical ingredient (API) producers, component suppliers, and packaging entities. Understanding the supply chain and key suppliers offers insight into product availability, manufacturing risks, and potential market dynamics.

Manufacturing and Supply Chain Overview

TWIRLA’s production involves sourcing raw materials, manufacturing API, assembling the patches, and packaging. Its supply chain is global, with multiple tiers of suppliers ensuring the integrity and consistency of each component. Given the regulatory complexity and high-quality standards demanded, suppliers undergo rigorous qualification processes aligned with FDA and international GMP (Good Manufacturing Practice) regulations.

Active Pharmaceutical Ingredient (API) Suppliers

The foundation of TWIRLA’s formulation lies in two hormones:

• Ethinyl Estradiol: A synthetic estrogen
• Levonorgestrel: A progestin

These APIs are at the core of TWIRLA’s transdermal delivery system. Major API suppliers operate globally, often located in India, China, and the United States, owing to their capacity for large-scale manufacturing under GMP conditions.

Key API Suppliers:

• Bayer Pharma (Germany): Bayer has historically supplied hormones like levonorgestrel and ethinyl estradiol for various contraceptive products, leveraging its integrated supply chain. While Bayer’s direct role in TWIRLA isn’t explicitly confirmed publicly, their API production facilities in Europe and North America make them a potential source.

• GMP-Compliant Asian API Manufacturers: Suppliers in India (e.g., Hetero Labs, Cipla), China (e.g., Shanghai Thomson Medical Co. Ltd.), and Korea manufacture APIs that may be used in TWIRLA’s formulation, given their global reach and high-quality standards.

• US-based Suppliers: Some US API producers, such as Fagron or Pfizer’s API units, may also provide pharmaceutical-grade APIs, ensuring compliance with US regulatory standards.

Note: The specific suppliers of API to TWIRLA are proprietary and not publicly disclosed, primarily due to competitive and regulatory confidentiality.

Component Suppliers

TWIRLA’s transdermal patches comprise several components:

• Backing Layer: Provides structural support.
• Drug Reservoir Layer: Contains the API and excipients.
• Adhesive Layer: Ensures adhesion to the skin.
• Protective Liner: Protects the patch during storage.

Materials and Adhesives:

• Polymer Films: Suppliers such as 3M or DuPont provide medical-grade polymers used in backing layers.
• Adhesive Components: Medical adhesives, possibly supplied by companies like Henkel or Avery Dennison, are critical for ensuring secure attachment and easy removal.
• Excipients and Fillers: Specialized excipients facilitate hormone stability and controlled release.

Manufacturing and Packaging

TWIRLA’s final assembly occurs at facilities compliant with GMP standards, often operated by large contract manufacturing organizations (CMOs).

• CMOs and Fill/Finish Contractors: Companies like Catalent, Lonza, or Recipharm are likely involved. These organizations handle the sterile filling, patch assembly, and packaging operations.

• Packaging Suppliers: These include firms specializing in pharmaceutical packaging, ensuring tamper-evidence, label integrity, and compliance with regulatory standards.

Key Risks and Considerations in the Supply Chain

• Regulatory Compliance: Suppliers must meet strict international standards, including FDA, EMA, and ICH guidelines.

• Supply Disruptions: The COVID-19 pandemic highlighted vulnerabilities in global supply chains, emphasizing the importance of diversified sourcing.

• Quality Control: Ensuring consistent API and component quality is fundamental, with suppliers subjected to rigorous qualification and audit processes.

• Intellectual Property and Confidentiality: Given the proprietary nature of TWIRLA’s formulation, detailed supplier information remains confidential.

Market Dynamics and Industry Trends

• Supplier Consolidation: Larger, integrated pharmaceutical companies increasingly consolidate to control quality and supply security.

• Nearshoring and Diversification: Manufacturers consider relocating or diversifying supply sources to mitigate geopolitical and pandemic-related risks.

• Emphasis on Sustainability: Suppliers are expected to adhere to increasingly stringent environmental and social governance (ESG) standards.

Conclusion

While the exact suppliers for TWIRLA remain undisclosed publicly, the device relies on a complex, multi-tiered supply chain involving API producers, component manufacturers, and CMOs compliant with international standards. Key players tend to be large, globally recognized firms capable of ensuring consistent quality and regulatory compliance. Market participants should monitor supplier regions and industry trends, given their potential impact on cost, availability, and product stability.

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Key Takeaways

• TWIRLA’s formulation hinges on high-quality APIs, likely sourced from global pharmaceutical leaders or GMP-compliant Asian manufacturers.
• The device’s production involves specialized materials and components supplied by prominent material science and adhesive companies.
• Contract manufacturing organizations (CMOs) play a pivotal role in the final assembly, emphasizing supply chain flexibility and quality.
• Supply chain resilience is critical amid geopolitical shifts, pandemics, and regulatory scrutiny.
• Transparency on specific suppliers is limited; industry players should leverage strategic sourcing and diversification to safeguard production.

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FAQs

1. Who are the primary API suppliers for TWIRLA?
The specific suppliers for TWIRLA’s APIs—ethinyl estradiol and levonorgestrel—are not publicly disclosed. Likely sources include GMP-certified producers in Europe, Asia, and North America, with key industry players like Bayer, Cipla, Hetero Labs, and others potentially involved.

2. Are there risks associated with the supply chain of TWIRLA?
Yes. Dependence on global suppliers introduces risks such as supply disruptions, regulatory delays, or quality concerns. Diversification and strategic sourcing are essential to mitigate these risks.

3. What companies manufacture the components of TWIRLA’s patches?
Major medical material manufacturers, including 3M, DuPont, Henkel, and Avery Dennison, supply the backing films, adhesives, and other components, typically through contract manufacturing arrangements.

4. How has the COVID-19 pandemic affected the supply chain for TWIRLA?
The pandemic caused disruptions across raw material supplies, manufacturing delays, and logistics challenges, prompting industry shifts toward supplier diversification and increased inventory buffers.

5. Will the supplier landscape for TWIRLA change in the future?
Potentially. Industry trends indicate ongoing consolidation, increasing regulatory standards, and geopolitical factors influencing sourcing decisions, which may alter the supplier landscape over time.

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Sources:

[1] FDA Guidelines and Drug Approval Data
[2] Industry reports on API manufacturing and supply chains
[3] Company disclosures and industry analyses (publicly available)
[4] Market research on transdermal drug delivery systems