Bulk Pharmaceutical API Sources for DETROL

Bulk Pharmaceutical API Sources for DETROL

Vendor	Vendor Homepage	Vendor Sku	API Url
Hangzhou APIChem Technology		AC-2617
Molport		MolPort-005-935-051
Oakwood Products		036545
BioChemPartner		BCP0726000292
AKos Consulting & Solutions		AKOS015961803
MedChemexpress MCE		HY-90010
AbaChemScene		CS-0441

Bulk Active Pharmaceutical Ingredient (API) Sources for: DETROL

Last updated: July 29, 2025

Introduction

Detrol, with the generic name tolterodine tartrate, is a conventional therapeutic agent primarily prescribed for the treatment of overactive bladder (OAB) symptoms, including urinary frequency, urgency, and incontinence. As with many pharmaceutical agents, the procurement of high-quality active pharmaceutical ingredients (APIs) is critical for pharmaceutical manufacturers aiming to ensure drug efficacy, safety, regulatory compliance, and cost competitiveness. This article provides an in-depth analysis of the global sources for bulk detrol APIs, exploring key manufacturers, geographic distributions, quality standards, and supply chain considerations.

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Overview of Detrol API: Tolterodine Tartrate

Chemical Profile:

• Chemical Name: (±)-N,N-Diethyl-3-(4-methylphenyl)-3-(2-oxazolidinylmethoxy)propan-1-amine tartrate
• Molecular Formula: C26H37NO7•C4H6O6 (tartrate salt)
• Molecular Weight: Approximately 476.59 g/mol (tartrate salt)

Detrol API is synthesized through complex chemical processes requiring high purity standards, typically adhering to regulations such as the United States Pharmacopeia (USP) or the European Pharmacopoeia (EP).

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Key Sources of Detrol API

1. Leading Global API Manufacturers

a) Aurobindo Pharma (India)

Aurobindo is a significant supplier of generic APIs, including tolterodine tartrate. Their manufacturing facilities are FDA-approved and adhere to cGMP standards, ensuring compliance with global quality benchmarks. Aurobindo's API plants are located primarily in India, providing cost competitiveness alongside quality assurance.

b) Zhejiang Huahai Pharmaceutical (China)

Huahai is recognized for producing a broad portfolio of APIs, with facilities certified by US FDA and EMA. Their tolterodine tartrate API is marketed globally and benefits from robust quality management systems, making them a key player in the Asian API supply chain.

c) Hetero Labs Ltd. (India)

Hetero is an established API manufacturer with a diverse portfolio, including tolterodine tartrate. Their GMP-certified manufacturing facilities and investment in quality control labs position them as a reliable source for pharmaceutical companies seeking bulk API.

d) Mylan (Now part of Viatris)

Mylan, a global generics giant, produces tolterodine tartrate API, primarily in manufacturing hubs in India and Europe. Their extensive distribution network ensures prompt supply to markets worldwide.

e) Jiangsu Hengrui Medicine Co., Ltd. (China)

Hengrui, a top Chinese pharmaceutical company, manufactures various APIs and finished drugs, with tolterodine tartrate included among their offerings. Their facilities are FDA- and EMA-certified, emphasizing quality and regulatory compliance.

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2. Regional and Niche API Suppliers

a) Synthesis & Contract Manufacturing Organizations (CMOs)

A surge in outsourcing has led to many specialized CMOs offering tolterodine tartrate API, often providing custom synthesis and scale-up capabilities tailored for proprietary formulations. Notable CMOs include:

• Laboratorios Melbi (Argentina)
• Alphapharm (India)
• GFC Chemicals (India)

b) Eastern European & Latin American Providers

Some European and Latin American manufacturers supply tolterodine tartrate, especially to regional markets where regional regulatory and logistical factors favor local sourcing.

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Supply Chain and Regulatory Considerations

Quality Assurance:
Manufacturers supplying APIs for regulated markets must comply with cGMP standards, with facilities inspected and certified by agencies such as the US FDA, EMA, or WHO. Transparency in quality documentation, stability data, and batch records is vital.

Regulatory Compliance:
API suppliers must ensure their processes align with current regulatory expectations, including validation of synthesis pathways, impurity profiling, and adherence to ICH guidelines.

Supply Security:
Given the critical role of APIs in pharmaceutical production, vaccine manufacturing, and generic drug release, establishing relationships with multiple approved suppliers mitigates risks associated with single-source dependency.

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Market Dynamics & Trends

Growing Demand:
The increasing prevalence of OAB globally sustains consistent demand for tolterodine tartrate, which influences markets to diversify sourcing to ensure supply chain resilience.

Quality and Cost Balance:
Manufacturers prioritize sources balancing cost-efficiency with stringent compliance to meet regulatory expectations, often favoring Indian and Chinese API producers due to cost advantages but rigorously vetting quality standards.

Trade & Export Data:
India and China dominate the global API export landscape, accounting for nearly 60-70% of the world's generic APIs, including tolterodine tartrate. Their scale, infrastructure, and regulatory collaborations allow competitive pricing and reliable supply.

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Future Outlook

Supply sources for detrol API are expected to expand with ongoing investments in biotechnology, process innovations, and quality management systems. The shift towards more sustainable, environmentally friendly manufacturing processes will also influence the selection of API suppliers. Moreover, as regulatory landscapes tighten, the credibility and certification of sources will become increasingly pivotal for market access.

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Key Takeaways

• Indian and Chinese manufacturers dominate the supply of tolterodine tartrate API, owing to their scale, cost advantages, and increasingly rigorous regulatory compliance.
• Leading suppliers such as Aurobindo, Hetero, and Zhejiang Huahai maintain cGMP-certified facilities aligned with international regulatory standards, ensuring quality and supply stability.
• Contract manufacturing organizations play a strategic role, offering flexible, customized synthesis options for pharmaceutical companies seeking diversified sourcing strategies.
• Regulatory compliance, supply chain security, and consistent quality traceability remain critical factors in selecting API sources for Detrol.
• The continued growth of the global OAB market and manufacturing innovations will shape future API sourcing strategies, emphasizing sustainable practices and enhanced quality controls.

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FAQs

Q1: What are the primary regions for sourcing tolterodine tartrate API?
A: India and China are the dominant regions for API manufacturing, with additional sources from Europe and Latin America.

Q2: How do regulatory standards influence API sourcing?
A: Suppliers must meet cGMP standards, with certifications from regulatory agencies such as the FDA or EMA, to ensure quality and legal compliance.

Q3: What factors are crucial when selecting an API supplier for Detrol?
A: Quality certifications, supply reliability, cost competitiveness, regulatory compliance, and transparency in documentation are key factors.

Q4: Are there any concerns with sourcing APIs from China or India?
A: While regulatory concerns exist, partnering with reputable, certified suppliers mitigates quality risks and ensures compliance.

Q5: How is the API supply chain expected to evolve?
A: It will become more diversified, with increased focus on sustainability, technological innovations, and stringent quality assurance.

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References

1. U.S. Food and Drug Administration (FDA). Establishment Inspections.
2. European Medicines Agency (EMA). Good Manufacturing Practice (GMP) Inspectors Working Group.
3. IQVIA. Global API Market Trends.
4. Pharma Intelligence. API Sourcing and Manufacturing Overview.
5. Industry Reports. Outlook on Overactive Bladder Treatments and API Supply Chains.