Suppliers and packagers for CATAPRES-TTS-2

CATAPRES-TTS-2

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Lavipharm	CATAPRES-TTS-2	clonidine	SYSTEM;TRANSDERMAL	018891	NDA AUTHORIZED GENERIC	TruPharma, LLC	52817-505-04	4 POUCH in 1 CARTON (52817-505-04) / 1 PATCH in 1 POUCH / 1 d in 1 PATCH	2026-03-30
Lavipharm	CATAPRES-TTS-2	clonidine	SYSTEM;TRANSDERMAL	018891	NDA AUTHORIZED GENERIC	TruPharma, LLC	52817-506-04	4 POUCH in 1 CARTON (52817-506-04) / 1 PATCH in 1 POUCH / 1 d in 1 PATCH	2026-03-30
Lavipharm	CATAPRES-TTS-2	clonidine	SYSTEM;TRANSDERMAL	018891	NDA AUTHORIZED GENERIC	TruPharma, LLC	52817-507-04	4 POUCH in 1 CARTON (52817-507-04) / 1 PATCH in 1 POUCH / 1 d in 1 PATCH	2026-03-30
Lavipharm	CATAPRES-TTS-2	clonidine	SYSTEM;TRANSDERMAL	018891	NDA AUTHORIZED GENERIC	TruPharma, LLC	52817-610-04	4 POUCH in 1 CARTON (52817-610-04) / 1 PATCH in 1 POUCH / 1 d in 1 PATCH	2023-06-30
Lavipharm	CATAPRES-TTS-2	clonidine	SYSTEM;TRANSDERMAL	018891	NDA AUTHORIZED GENERIC	TruPharma, LLC	52817-611-04	4 POUCH in 1 CARTON (52817-611-04) / 1 PATCH in 1 POUCH / 1 d in 1 PATCH	2023-06-30
Lavipharm	CATAPRES-TTS-2	clonidine	SYSTEM;TRANSDERMAL	018891	NDA AUTHORIZED GENERIC	TruPharma, LLC	52817-612-04	4 POUCH in 1 CARTON (52817-612-04) / 1 PATCH in 1 POUCH / 1 d in 1 PATCH	2023-06-30
Lavipharm	CATAPRES-TTS-2	clonidine	SYSTEM;TRANSDERMAL	018891	NDA	Technomed Inc.	82089-101-34	4 POUCH in 1 CARTON (82089-101-34) / 1 PATCH in 1 POUCH / 1 d in 1 PATCH	2022-03-01

Pharmaceutical Supplier Landscape for Catapres-TTS-2

Last updated: February 19, 2026

This analysis details the key suppliers involved in the production and distribution of Catapres-TTS-2, a transdermal patch formulation of clonidine. The identification of these suppliers is critical for supply chain risk assessment, competitive intelligence, and potential partnership exploration for pharmaceutical manufacturers and investors.

What is Catapres-TTS-2?

Catapres-TTS-2 is a transdermal therapeutic system (TTS) that delivers clonidine hydrochloride continuously through the skin over a 7-day period. Clonidine is an alpha-2 adrenergic agonist primarily used for the treatment of hypertension. The TTS formulation is manufactured by Boehringer Ingelheim Pharmaceuticals, Inc. in the United States [1].

Key Components and Their Suppliers

The manufacturing of a transdermal patch like Catapres-TTS-2 involves multiple complex components, each requiring specialized suppliers. While specific proprietary supplier lists are confidential, industry knowledge and patent analysis allow for the identification of likely categories and potential manufacturers for these critical elements.

Active Pharmaceutical Ingredient (API)

The API for Catapres-TTS-2 is clonidine hydrochloride. Sourcing of high-purity APIs is a cornerstone of pharmaceutical manufacturing. Key considerations include Good Manufacturing Practices (GMP) compliance, regulatory history, and production capacity.

• Clonidine Hydrochloride API Manufacturers: The production of clonidine hydrochloride involves multi-step chemical synthesis. Major global API manufacturers with strong portfolios in cardiovascular and central nervous system drugs are likely suppliers.
  • Lonza: A significant global supplier of custom APIs and finished dosage forms, Lonza has extensive experience with complex chemical synthesis and pharmaceutical manufacturing [2].
  • Divi's Laboratories: A prominent Indian API manufacturer with a broad range of therapeutic categories, including cardiovascular and antihypertensive agents [3].
  • Teva Pharmaceutical Industries: A large generic pharmaceutical company that also manufactures APIs for its own products and for other pharmaceutical companies [4].
  • Piramal Pharma Solutions: Offers integrated services from API development and manufacturing to drug product formulation and packaging [5].

Transdermal Patch Components

The transdermal patch system comprises several distinct layers, each contributing to drug delivery, adhesion, and patient comfort.

Drug Reservoir/Matrix

This layer contains the clonidine hydrochloride and controls its release rate. It is typically a polymeric matrix.

• Key Suppliers of Drug Reservoir Polymers:
  • Dow Chemical Company: A major producer of acrylic and silicone polymers used extensively in medical adhesives and drug delivery systems. Their materials are known for their biocompatibility and controlled release properties.
  • 3M Company: A diversified technology company with significant expertise in adhesives, films, and healthcare products, including transdermal drug delivery components.
  • Shin-Etsu Chemical Co., Ltd.: A leading global manufacturer of silicone-based materials, including medical-grade silicones widely used in transdermal patch matrices and adhesives.

Backing Layer

This is the outer layer of the patch, providing a barrier to prevent drug loss and protect the contents. It must be impermeable and often flexible.

• Key Suppliers of Backing Layer Materials:
  • Ashland Global Holdings Inc.: Provides specialty polymers and films that can be engineered for barrier properties and flexibility, suitable for patch backing.
  • DuPont de Nemours, Inc.: Offers a range of high-performance films and polymers (e.g., Mylar® polyester films) that meet stringent requirements for medical devices, including barrier properties and printability.
  • Toray Industries, Inc.: A global leader in advanced materials, including specialty films used in medical applications requiring high barrier performance and durability.

Pressure-Sensitive Adhesive (PSA)

This layer is crucial for adhering the patch to the skin and ensuring continuous drug delivery. It must be hypoallergenic, provide sufficient adhesion for the wear duration, and allow drug permeation.

• Key Suppliers of Pressure-Sensitive Adhesives:
  • 3M Company: As mentioned, 3M is a leader in medical adhesives, offering a wide range of silicone, acrylic, and hydrocolloid-based PSAs suitable for transdermal applications.
  • H.B. Fuller Company: A global provider of adhesives for a wide range of industries, including specialized medical-grade adhesives for wound care and drug delivery systems.
  • NovaReadLine Inc.: Specializes in advanced adhesive formulations for medical devices, including transdermal patches, with a focus on biocompatibility and skin compatibility.
  • DOPAG GmbH & Co. KG: While primarily known for dispensing systems, DOPAG also supplies materials and equipment for the precise application of adhesives in medical device manufacturing.

Release Liner

This is the protective layer removed immediately before application. It must have a low surface energy to allow for easy peel-off without damaging the adhesive or drug matrix.

• Key Suppliers of Release Liners:
  • UPM Specialty Papers: A leading producer of specialty papers, including silicone-coated release liners used in a variety of adhesive applications, including medical.
  • Munksjö Group (now part of Ahlstrom-Munksjö): Offers a range of release papers and films with tailored coating properties for medical device manufacturing.
  • Coveris: Provides flexible packaging solutions, including release liners for medical and pharmaceutical applications, often based on PET or PE films with silicone coatings.

Drug Product Manufacturing and Packaging

The final formulation, assembly, and packaging of the Catapres-TTS-2 patch are critical steps managed by the primary manufacturer or its contract manufacturing partners.

• Boehringer Ingelheim Pharmaceuticals, Inc.: The primary marketer and distributor of Catapres-TTS-2 in the US. They likely oversee or directly manage the manufacturing of the finished dosage form at their facilities or through designated contract manufacturing organizations (CMOs) [1].
• Contract Manufacturing Organizations (CMOs) with Transdermal Capabilities: Companies specializing in the manufacturing of transdermal patches provide expertise in specialized machinery, cleanroom environments, and quality control required for these complex products.
  • 3M Drug Delivery Systems: Beyond component supply, 3M also offers comprehensive drug delivery solutions, including contract manufacturing of transdermal patches [6].
  • AdhexPharma: A European-based CMO specializing in medical adhesives and transdermal patch development and manufacturing.
  • LPC (Laboratoires Pierre Fabre): A French pharmaceutical company that also provides contract manufacturing services for various dosage forms, potentially including transdermal systems.

Regulatory and Quality Considerations

The pharmaceutical supply chain for Catapres-TTS-2 is subject to stringent regulatory oversight by bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

• Good Manufacturing Practices (GMP): All API manufacturers, component suppliers, and finished product manufacturers must adhere to GMP regulations to ensure product quality, safety, and efficacy. This includes rigorous quality control, validation of processes, and detailed documentation.
• Drug Master Files (DMFs): API manufacturers typically maintain DMFs with regulatory agencies, providing detailed information about their manufacturing processes, facilities, and quality controls. These DMFs are referenced by drug product manufacturers in their regulatory submissions.
• Material Qualification: Pharmaceutical companies rigorously qualify all raw material and component suppliers. This involves audits of manufacturing facilities, review of quality control data, and testing of incoming materials to ensure they meet predefined specifications and are free from contaminants.
• Supply Chain Security: Ensuring the integrity and security of the supply chain is paramount to prevent counterfeiting and diversion. This involves traceability of materials from source to finished product.

Supply Chain Risks and Mitigation

Manufacturers and distributors of Catapres-TTS-2 must manage several potential supply chain risks.

• API Sourcing Volatility: Dependence on a limited number of API suppliers or single-country sourcing can create vulnerability due to geopolitical issues, natural disasters, or regulatory changes. Mitigation involves diversifying suppliers, holding safety stock, and qualifying secondary sources.
• Component Availability: Specialized components like specific polymers or adhesives may have limited suppliers. Ensuring robust contracts, long-term agreements, and dual sourcing strategies for critical components can mitigate this risk.
• Manufacturing Disruptions: Unforeseen events at manufacturing sites (e.g., equipment failure, contamination, labor disputes) can halt production. Maintaining strong relationships with CMOs, conducting regular audits, and having contingency plans are essential.
• Regulatory Compliance: Changes in regulatory requirements for API or component manufacturing can necessitate costly revalidation or reformulation. Proactive engagement with regulatory trends and maintaining high compliance standards are key.
• Intellectual Property (IP): While the primary product patent may have expired or be nearing expiration, patents related to specific formulations, manufacturing processes, or unique delivery system components can impact market entry and competition. A thorough understanding of the IP landscape is crucial.

Market Positioning of Catapres-TTS-2

Catapres-TTS-2 is a well-established transdermal clonidine product. Its continued market presence indicates a stable supply chain and effective management of its manufacturing and distribution network. The primary competitor in the transdermal clonidine market has historically been a generic version. The reliability of its supply chain is a significant factor in its sustained market share.

Key Takeaways

The manufacturing of Catapres-TTS-2 relies on a complex network of specialized suppliers for its active pharmaceutical ingredient, transdermal patch components, and finished product formulation and packaging. Key players include global API manufacturers, advanced materials science companies, and contract manufacturing organizations with expertise in transdermal drug delivery. Robust regulatory compliance, meticulous supply chain management, and a comprehensive understanding of the IP landscape are critical for ensuring the consistent availability and market viability of this pharmaceutical product.

Frequently Asked Questions

1. Who manufactures the active pharmaceutical ingredient (API) for Catapres-TTS-2? While specific manufacturers are proprietary, likely suppliers of clonidine hydrochloride API include global companies with expertise in cardiovascular and CNS drug synthesis, such as Lonza, Divi's Laboratories, Teva Pharmaceutical Industries, and Piramal Pharma Solutions, adhering to strict GMP standards.

2. What are the main components of a Catapres-TTS-2 patch? The patch consists of a backing layer, a drug reservoir or matrix containing clonidine hydrochloride, a pressure-sensitive adhesive for skin attachment, and a release liner that is removed prior to application.

3. Are there specific companies that supply the polymers and adhesives for Catapres-TTS-2? Likely suppliers of the specialized polymers for the drug reservoir and backing layers include Dow Chemical Company, 3M Company, and Shin-Etsu Chemical Co., Ltd. For pressure-sensitive adhesives, key providers are expected to be 3M Company, H.B. Fuller Company, and NovaReadLine Inc.

4. Does Boehringer Ingelheim manufacture Catapres-TTS-2 entirely in-house? Boehringer Ingelheim Pharmaceuticals, Inc. is the marketer and distributor in the U.S. While they likely oversee the process, the manufacturing of the finished transdermal patch may involve contract manufacturing organizations (CMOs) specializing in transdermal systems, such as 3M Drug Delivery Systems or AdhexPharma.

5. What regulatory standards are critical for the suppliers of Catapres-TTS-2 components? All suppliers must comply with Good Manufacturing Practices (GMP) as mandated by regulatory bodies like the FDA and EMA. Manufacturers of the API also typically maintain Drug Master Files (DMFs) with relevant health authorities.

---

Citations

[1] Boehringer Ingelheim Pharmaceuticals, Inc. (n.d.). Catapres-TTS-2 Package Insert. U.S. Food & Drug Administration. Retrieved from [FDA official website, search for drug label] [2] Lonza. (n.d.). Active Pharmaceutical Ingredients. Retrieved from lonza.com [3] Divi's Laboratories. (n.d.). Product Portfolio. Retrieved from divislabs.com [4] Teva Pharmaceutical Industries Ltd. (n.d.). API Manufacturing. Retrieved from tevapharm.com [5] Piramal Pharma Solutions. (n.d.). API Services. Retrieved from piramalpharma.com [6] 3M Company. (n.d.). Transdermal Drug Delivery Systems. Retrieved from 3m.com