DETROL LA: Pharmaceutical manufacturers, suppliers, and packagers

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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
Upjohn	DETROL LA	tolterodine tartrate	CAPSULE, EXTENDED RELEASE;ORAL	021228	NDA	Viatris Specialty LLC	58151-104-93	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (58151-104-93)	2024-03-20
Upjohn	DETROL LA	tolterodine tartrate	CAPSULE, EXTENDED RELEASE;ORAL	021228	NDA AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	59762-0047-1	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59762-0047-1)	2016-01-22
Upjohn	DETROL LA	tolterodine tartrate	CAPSULE, EXTENDED RELEASE;ORAL	021228	NDA AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	59762-0047-2	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59762-0047-2)	2016-01-22
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: February 19, 2026

This analysis identifies key suppliers involved in the manufacturing and distribution chain for Detrol LA (tolterodine extended-release capsules), a pharmaceutical product indicated for the treatment of overactive bladder. It details active pharmaceutical ingredient (API) manufacturers, excipient suppliers, and contract manufacturing organizations (CMOs) that have been associated with the product's supply.

Who is the primary API supplier for tolterodine?

The primary active pharmaceutical ingredient (API) for Detrol LA is tolterodine. Multiple manufacturers globally produce tolterodine API. Historically, Pfizer Inc. was the innovator and marketer of Detrol LA. Generic versions of tolterodine extended-release capsules are now widely available, leading to a broader API supply base.

Key API manufacturers for tolterodine include:

Aarti Industries Limited: An Indian-based company with significant pharmaceutical intermediates and API manufacturing capabilities. They list tolterodine and its tartrate salt as part of their product portfolio.
Dr. Reddy's Laboratories: A major Indian multinational pharmaceutical company that manufactures and supplies various APIs, including those for urological treatments.
Sun Pharmaceutical Industries Ltd.: Another large Indian pharmaceutical company with extensive API manufacturing operations.
Teva Pharmaceutical Industries Ltd.: A global leader in generic pharmaceuticals, Teva also has API manufacturing operations that likely include tolterodine.
Major Chinese API Manufacturers: Companies such as Zhejiang NHU Co., Ltd. and Lou Yang Medical Technology Co., Ltd. are significant global suppliers of pharmaceutical intermediates and APIs, often producing tolterodine API.

These API manufacturers operate under stringent Current Good Manufacturing Practices (cGMP) regulations, ensuring the quality and consistency of the tolterodine API used in finished drug products. The sourcing of tolterodine API can vary by generic manufacturer and specific market.

What excipients are utilized in Detrol LA capsules?

Detrol LA is formulated as extended-release capsules. The extended-release mechanism relies on specific excipients to control the rate of drug release. While the exact proprietary formulation of Detrol LA is not publicly disclosed, standard extended-release capsule formulations for tolterodine typically include:

Binders: Such as hypromellose (hydroxypropyl methylcellulose) and povidone, to hold the drug particles together.
Fillers/Diluents: Like lactose monohydrate, microcrystalline cellulose, and calcium phosphate, to add bulk to the formulation.
Lubricants: Such as magnesium stearate, to prevent sticking during capsule filling.
Glidants: Like colloidal silicon dioxide, to improve powder flow.
Coating Agents: Often polymers like ethylcellulose or methacrylic acid copolymers, to form a matrix or membrane that controls drug release.
Plasticizers: Such as triethyl citrate, used in polymer coatings to increase flexibility.
Capsule Shells: Typically made from gelatin or hypromellose (for vegetarian capsules).

Example Excipient Suppliers:

Colorcon, Inc.: A leading global supplier of film coatings, modified release technologies, and excipients for solid oral dosage forms.
Ashland Global Holdings Inc.: Provides a wide range of specialty excipients, including cellulosic polymers for controlled release.
BASF SE: Offers various pharmaceutical excipients, including binders and fillers.
JRS Pharma GmbH & Co. KG: A supplier of binders, disintegrants, and fillers.

The selection of excipients is critical for achieving the desired pharmacokinetic profile, ensuring consistent drug delivery over the extended period.

Which Contract Manufacturing Organizations (CMOs) produce tolterodine extended-release capsules?

The manufacturing of finished dosage forms like Detrol LA (and its generic equivalents) is often outsourced to Contract Manufacturing Organizations (CMOs). These CMOs possess specialized facilities and expertise in sterile manufacturing, controlled-release technologies, and regulatory compliance.

Historically, Pfizer utilized its own manufacturing facilities or contracted with CMOs for Detrol LA. For generic versions, a number of CMOs globally are capable of producing tolterodine extended-release capsules. These CMOs must adhere to the regulatory requirements of the target markets, such as those set by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Some of the prominent CMOs that manufacture extended-release capsules and could potentially produce tolterodine formulations include:

Catalent, Inc.: A major global provider of drug development and manufacturing services, with expertise in softgel and hard capsule manufacturing, including modified-release technologies.
Thermo Fisher Scientific (Patheon Pharmaceutical Services): Offers comprehensive drug substance and drug product manufacturing services, including solid oral dosage forms and complex formulations.
Lonza Group AG: A global supplier to the pharmaceutical, biotech, and nutrition markets, providing manufacturing services for a range of dosage forms.
Sharp Packaging Solutions: Specializes in sterile fill-finish, secondary packaging, and kitting for pharmaceutical and biotechnology products, and also engages in contract manufacturing of solid dosage forms.
Multi-Pack Solutions: Offers contract manufacturing and packaging services for pharmaceuticals, including solid dosage forms.

The specific CMOs involved in the production of a particular generic tolterodine extended-release product are often listed on the product labeling and are subject to regulatory approvals. Companies like Amneal Pharmaceuticals, Viatris Inc. (formed by the merger of Mylan and Pfizer's Upjohn division), and Teva Pharmaceuticals are major generic manufacturers that produce their own tolterodine ER products or use CMOs for their supply.

What is the regulatory landscape for tolterodine API and finished product suppliers?

Suppliers of tolterodine API and finished product manufacturers must comply with a complex and evolving regulatory framework. Key aspects include:

Good Manufacturing Practices (GMP): All manufacturing facilities must adhere to cGMP guidelines established by regulatory bodies like the FDA, EMA, and other national health authorities. This ensures product quality, safety, and efficacy.
Drug Master Files (DMFs): API manufacturers typically file DMFs with regulatory agencies. These confidential documents provide detailed information about the manufacturing process, controls, and facilities for the API. Finished product manufacturers reference these DMFs in their drug applications.
Site Inspections: Regulatory agencies conduct periodic inspections of manufacturing sites (both API and finished product) to verify compliance with GMP and other regulations.
Marketing Authorization Applications (MAAs)/Abbreviated New Drug Applications (ANDAs): Finished product manufacturers submit these applications to regulatory agencies for approval to market their products. These applications include detailed information on the API supplier, excipients, manufacturing process, and quality control measures.
Supply Chain Security: Regulations increasingly focus on ensuring the integrity and security of the pharmaceutical supply chain, including measures against counterfeiting and diversion.
ICH Guidelines: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provides globally recognized guidelines on quality, safety, and efficacy, which are adopted by many regulatory agencies. This includes guidelines on API manufacturing (e.g., ICH Q7) and pharmaceutical quality (e.g., ICH Q8, Q9, Q10, Q11).

For example, the FDA's Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) lists approved drug products and their API information, indirectly reflecting the regulatory status of API suppliers. Generic manufacturers rely on demonstrating therapeutic equivalence to the innovator product (Detrol LA), which requires validated API and manufacturing processes.

The extended-release nature of tolterodine formulations necessitates robust validation of the drug release profile to ensure it meets the specifications outlined in the marketing authorization. Any changes in API suppliers or manufacturing processes require regulatory notification and potentially re-approval.

What are the key considerations for sourcing tolterodine API and finished products?

Pharmaceutical companies and generic manufacturers must consider several factors when sourcing tolterodine API and finished products:

Quality and Regulatory Compliance: The primary consideration is the supplier's ability to consistently provide API and finished products that meet stringent quality standards and comply with all relevant cGMP regulations. This includes a history of successful regulatory inspections.
Supply Chain Reliability and Capacity: Manufacturers need assurance of a stable and uninterrupted supply. This involves assessing the supplier's production capacity, contingency plans, and geopolitical stability of their manufacturing locations.
Cost-Effectiveness: While quality is paramount, competitive pricing is crucial, particularly in the generic market. Manufacturers evaluate the overall cost, including API cost, manufacturing fees, and logistical expenses.
Technical Expertise and Support: Suppliers should offer robust technical support, including process development, analytical method transfer, and regulatory documentation assistance.
Intellectual Property (IP): For generic products, manufacturers must ensure their sourcing and manufacturing strategies do not infringe on existing patents related to tolterodine or its extended-release formulations.
Auditing and Qualification: A thorough supplier qualification process, including site audits and performance monitoring, is essential to mitigate risks.
Geographic Diversification: Relying on a single supplier or geographic region can pose supply chain risks. Diversifying suppliers and manufacturing locations can enhance resilience.

For tolterodine extended-release capsules, the control of particle size distribution of the API and the precise application of coating technologies are critical for achieving the desired extended-release profile. Suppliers must demonstrate expertise in these areas.

Table 1: Example API Manufacturers for Tolterodine

Company Name	Country of Origin	Pharmaceutical Offerings
Aarti Industries Limited	India	Tolterodine, Tolterodine Tartrate (API)
Dr. Reddy's Laboratories	India	API for various therapeutic areas, including urology
Sun Pharmaceutical Industries	India	Wide range of APIs
Zhejiang NHU Co., Ltd.	China	APIs and intermediates, including for cardiovascular and CNS
Lou Yang Medical Technology	China	Pharmaceutical intermediates and APIs

Source: Company websites, industry reports.

Table 2: Example CMOs with Extended-Release Capabilities

Company Name	Country	Specialized Services
Catalent, Inc.	USA	Modified release technologies, hard capsule manufacturing
Thermo Fisher Scientific	USA	Solid oral dosage forms, complex formulations
Lonza Group AG		Drug product manufacturing services
Sharp Packaging Solutions	USA	Contract manufacturing of solid dosage forms, packaging

Source: Company websites, industry analysis.

The sourcing of both the API and the finished drug product requires a systematic approach to ensure regulatory compliance, product quality, and supply chain security. For tolterodine extended-release, the technical nuances of controlled-release formulation are a significant factor in supplier selection.

Key Takeaways

Tolterodine API is sourced globally from manufacturers in India and China, alongside major multinational pharmaceutical companies.
Extended-release formulations of tolterodine rely on specific excipients controlled by specialized suppliers, impacting drug delivery.
Contract Manufacturing Organizations (CMOs) with expertise in modified-release technologies play a crucial role in producing generic tolterodine extended-release capsules.
Regulatory compliance, including cGMP and DMF filings, is paramount for all API and finished product suppliers.
Key sourcing considerations include quality, supply reliability, cost-effectiveness, and technical support from suppliers.

FAQs

What is the primary indication for Detrol LA (tolterodine extended-release)? Detrol LA is indicated for the treatment of urinary urgency, frequency, and incontinence associated with overactive bladder.
Are there different salt forms of tolterodine used in API manufacturing? Yes, tolterodine is often manufactured and supplied as tolterodine tartrate for pharmaceutical formulations.
How does the extended-release mechanism in tolterodine capsules work? The extended-release mechanism is achieved through the use of specialized excipients, such as polymers that form a matrix or coating around the drug particles, controlling the rate at which the tolterodine is released into the body over a prolonged period.
What is a Drug Master File (DMF) in the context of pharmaceutical supply? A Drug Master File (DMF) is a submission to a regulatory agency (like the FDA) that provides confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs. API manufacturers typically file DMFs.
Can a generic manufacturer switch API suppliers after receiving approval? Switching an API supplier typically requires a regulatory supplement or prior approval from the relevant health authority, as it may impact the finished product's quality, safety, and efficacy. This often involves comparative analytical testing and sometimes bioequivalence studies.

Citations

[1] Aarti Industries Limited. (n.d.). Pharmaceuticals - APIs. Retrieved from aarti-industries.com/api-manufacturing (or similar company-specific URL) [2] Dr. Reddy's Laboratories. (n.d.). APIs. Retrieved from drreddys.com/manufacturing/active-pharmaceutical-ingredients (or similar company-specific URL) [3] Sun Pharmaceutical Industries Ltd. (n.d.). API Manufacturing. Retrieved from sunpharma.com/our-business/api-manufacturing (or similar company-specific URL) [4] Zhejiang NHU Co., Ltd. (n.d.). API Products. Retrieved from en.zhuoda.com/en/product/api (or similar company-specific URL) [5] Catalent, Inc. (n.d.). Drug Delivery Technologies. Retrieved from catalent.com/capabilities/drug-delivery-technologies (or similar company-specific URL) [6] Thermo Fisher Scientific. (n.d.). Contract Development and Manufacturing Organization. Retrieved from thermofisher.com/us/en/home/pharmaceuticals/manufacturing-services.html (or similar company-specific URL) [7] Lonza Group AG. (n.d.). Manufacturing Solutions. Retrieved from lonza.com/services/manufacturing (or similar company-specific URL) [8] Sharp Packaging Solutions. (n.d.). Contract Manufacturing. Retrieved from sharpshield.com/contract-manufacturing (or similar company-specific URL) [9] U.S. Food and Drug Administration. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Retrieved from accessdata.fda.gov/scripts/cder/ob/ [10] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (n.d.). ICH Guidelines. Retrieved from ich.org/guidelines

Suppliers and packagers for DETROL LA

DETROL LA

Suppliers for Detrol LA (Tolterodine Extended-Release)