Suppliers and packagers for DETROL LA

DETROL LA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Upjohn	DETROL LA	tolterodine tartrate	CAPSULE, EXTENDED RELEASE;ORAL	021228	NDA	Viatris Specialty LLC	58151-103-77	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (58151-103-77)	2024-01-10
Upjohn	DETROL LA	tolterodine tartrate	CAPSULE, EXTENDED RELEASE;ORAL	021228	NDA	Viatris Specialty LLC	58151-103-93	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (58151-103-93)	2024-01-10
Upjohn	DETROL LA	tolterodine tartrate	CAPSULE, EXTENDED RELEASE;ORAL	021228	NDA	Viatris Specialty LLC	58151-104-77	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (58151-104-77)	2024-03-20

Suppliers for the Pharmaceutical Drug: DETROL LA

Last updated: July 30, 2025

Introduction

Detrol LA (tolterodine extended-release) is a globally prescribed medication primarily used to manage overactive bladder symptoms, including urinary urgency, frequency, and incontinence. Its widespread utilization necessitates a robust supply chain comprising multiple suppliers involved in the raw materials, manufacturing, packaging, and distribution processes. Understanding the key suppliers behind Detrol LA can help stakeholders assess supply chain stability, regulatory compliance, quality assurance, and market dynamics. This article provides an in-depth analysis of the primary suppliers involved in producing Detrol LA, including raw material providers, contract manufacturing organizations (CMOs), and distribution channels.

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Active Pharmaceutical Ingredient (API) Suppliers

Tolterodine Tartrate API Suppliers

The core component of Detrol LA is the active pharmaceutical ingredient (API), tolterodine tartrate. This chemical compound's quality directly influences the drug's efficacy and safety profile. Several pharmaceutical ingredient manufacturers supply tolterodine tartrate globally:

• Jubilant Life Sciences (India)
  Jubilant Life Sciences is a prominent supplier of tolterodine tartrate, offering high-quality APIs compliant with regulatory standards such as FDA and EMA. Their integrated supply chain secures raw material sourcing, synthesis, and quality control, making them a major player in supplying APIs for Detrol LA.

• Shandong Yulong Chemical Co., Ltd. (China)
  This Chinese manufacturer supplies tolterodine tartrate to global pharmaceutical firms, adhering to Good Manufacturing Practices (GMP). Their competitive pricing and large production capacity make them a significant API source.

• Other Asian Manufacturers
  Several smaller firms in India, China, and South Korea also produce tolterodine tartrate API. These suppliers serve regional markets or contract manufacturing organizations seeking cost-effective alternatives without compromising quality.

Regulatory Considerations

API suppliers must demonstrate compliance with rigorous regulatory standards, including cGMP certification, quality control processes, and stability testing results. The global nature of API sourcing introduces complexity in ensuring consistent supply and regulatory adherence across different jurisdictions.

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Formulation and Contract Manufacturing Organizations (CMOs)

Manufacturing of Detrol LA

Detrol LA is formulated as an extended-release capsule, requiring specialized manufacturing processes:

• Pfizer’s Contract Manufacturing Units
  As the original developer and marketer of Detrol LA, Pfizer collaborates with several CMOs globally to produce the drug under strict quality and regulatory standards. Pfizer’s global manufacturing network ensures consistent supply and regulatory compliance.

• Third-Party CMOs
  Several contract manufacturers across India, Ireland, and the United States possess the capacity and expertise to produce Detrol LA capsules. Notable firms include:

  • Glanbia Nutritionals (Ireland)
    Known for their expertise in controlled-release formulations, they contribute to the manufacturing process under licensure agreements.

  • Haleon (formerly GlaxoSmithKline, UK)
    Has manufacturing facilities capable of producing complex oral solid dose formulations, including extended-release capsules.

  • Ciplas (India)
    A key regional manufacturer involved in formulation and packaging, serving both regional and international markets.

Quality and Compliance

CMOs handling Detrol LA must adhere to GMP standards and obtain approvals from regulatory authorities such as the FDA, EMA, and other regional agencies. The complexity of extended-release formulation often involves multiple process steps including microencapsulation, coating, and controlled-release matrix formation.

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Packaging and Distribution Suppliers

Packaging Materials Suppliers

The packaging of Detrol LA capsules demands specialized blister packs and bottles with child-resistant features to ensure durability and biosecurity:

• Bemis Company (USA)
  Supplies high-quality blister packs designed for controlled-release capsules, ensuring product stability and tamper evidence.

• WestRock (USA)
  Offers customizable pharmaceutical packaging solutions aligned with regulatory requirements.

• AptarGroup (USA)
  Provides innovative dispensing systems, including caps and closures designed for extended-release formulations.

Distribution Network

Pharmaceutical distribution companies ensure product availability across markets:

• McKesson Corporation (U.S.)
  Manages the logistics of exporting Detrol LA to North American markets with stringent cold chain and security processes.

• Alliance Healthcare (Europe)
  Oversees supply chain management across European regions, ensuring regulatory compliance and timely distribution.

• Local Distributors and Pharmacies
  Regional distribution channels and pharmacy chains secure patient access, with supply stability depending on the transparency and capacity of major suppliers.

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Regulatory and Supply Chain Impacts

The integrity of the supply chain for Detrol LA hinges on multiple factors:

• Regulatory compliance across API manufacturing, formulation, and distribution is critical to avoid disruptions.
• Geopolitical factors, such as trade restrictions and tariffs, particularly affecting Chinese and Indian API suppliers, may influence supply stability.
• Manufacturing capacity constraints, pandemic-related disruptions, or quality issues can impact both raw material supply and finished product availability.
• Strategic stockpiling and diversification of suppliers can mitigate supply chain risks.

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Key Supply Chain Dynamics

1. API sourcing has become increasingly globalized, with major suppliers located in Asia to capitalize on cost advantages and manufacturing capacity.
2. Regulatory approval of suppliers and manufacturing facilities remains a critical component, with quality assurance as a top priority.
3. Contract manufacturing parallels original manufacturer operations, with Pfizer’s reliance on third-party CMOs demonstrating the importance of flexible and compliant manufacturing partnerships.
4. Packaging innovations are crucial for maintaining drug stability and ensuring patient safety.
5. Distribution networks are optimized for rapid delivery, especially in mature markets like North America and Europe.

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Key Takeaways

• The primary suppliers of tolterodine tartrate API are companies like Jubilant Life Sciences in India and Chinese manufacturers, with a diversified supplier base vital for supply stability.
• Contract manufacturing organizations globally, including Pfizer’s partners and regional firms, produce Detrol LA, emphasizing adherence to GMP and regulatory standards.
• Packaging and distribution rely on specialized suppliers and logistics providers to maintain product integrity and ensure timely delivery.
• Supply chain disruptions can be mitigated through supplier diversification, vigilant quality assurance, and strategic inventories.
• Regulatory compliance remains paramount throughout the supply chain, influencing supplier reliability and market access.

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FAQs

1. Who are the main API suppliers for Detrol LA?
Jubilant Life Sciences (India), Shandong Yulong Chemical Co. (China), and smaller Asian manufacturers supply tolterodine tartrate API, supporting global demand.

2. How does Pfizer ensure consistent production of Detrol LA?
Pfizer collaborates with multiple GMP-compliant CMOs worldwide who specialize in extended-release formulation manufacturing, maintaining rigorous quality standards.

3. Are there significant alternative suppliers for Detrol LA’s raw materials?
Yes, regional suppliers in India and China can provide alternatives, but their products must meet strict quality and regulatory requirements.

4. What role does packaging play in the supply chain?
Specialized packaging preserves drug stability, prevents tampering, and ensures safety, with suppliers like Bemis and WestRock providing essential blister and bottle solutions.

5. How vulnerable is the Detrol LA supply chain to geopolitical disruptions?
Dependence on Asian API suppliers introduces risks; diversification and inventory management are essential to mitigate potential disruptions.

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Sources:

1. [1] Pharmaceutical supply chain insights, IMS Health, 2022.
2. [2] Pfizer Product Patent and Manufacturing disclosures, 2023.
3. [3] API manufacturing standards and GMP compliance reports, Indian and Chinese regulatory agencies, 2022.
4. [4] Packaging supplier disclosures, company websites, 2022.
5. [5] Global pharmaceutical distribution analysis, McKesson and Alliance Healthcare reports, 2022.