FLAVOXATE HYDROCHLORIDE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Epic Pharma	FLAVOXATE HYDROCHLORIDE	flavoxate hydrochloride	TABLET;ORAL	076835	ANDA	PuraCap Laboratories LLC dba Blu Pharmaceuticals	24658-720-01	100 TABLET in 1 BOTTLE (24658-720-01)	2016-12-15
Epic Pharma	FLAVOXATE HYDROCHLORIDE	flavoxate hydrochloride	TABLET;ORAL	076835	ANDA	Epic Pharma, LLC	42806-058-01	100 TABLET in 1 BOTTLE (42806-058-01)	2011-02-21
Epic Pharma	FLAVOXATE HYDROCHLORIDE	flavoxate hydrochloride	TABLET;ORAL	076835	ANDA	Epic Pharma, LLC	42806-058-10	1000 TABLET in 1 BOTTLE (42806-058-10)	2011-02-21
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

Flavoxate hydrochloride is a well-established urinary antispasmodic used to treat bladder spasms, overactive bladder, and other voiding dysfunctions. As a crucial component in managing urinary disorders, its supply chain and manufacturing sources are vital for pharmaceutical companies, healthcare providers, and regulatory agencies. This article offers a comprehensive overview of the primary suppliers for flavoxate hydrochloride, analyzing their manufacturing capabilities, geographic distribution, and compliance standards to aid business decision-making within the pharmaceutical supply chain.

Overview of Flavoxate Hydrochloride Production

Flavoxate hydrochloride is a synthetic compound classified as a urinary antispasmodic agent. It was first introduced in the 1960s and has since become part of standard pharmacological treatment for bladder control issues. Its synthesis involves complex organic chemistry processes, requiring advanced manufacturing facilities that adhere to strict quality and regulatory standards, such as Good Manufacturing Practice (GMP).

The demand for flavoxate hydrochloride hinges on its approved indications, market penetration in generic and branded segments, and global health initiatives. As with many pharmaceuticals, the supply chain includes active pharmaceutical ingredient (API) manufacturers, excipient suppliers, and finished dosage form producers.

Major API Suppliers of Flavoxate Hydrochloride

1. Indian Manufacturers

India remains a dominant player in the global pharmaceutical API sector, benefiting from cost advantages, robust manufacturing infrastructure, and compliance with international standards. Several Indian API producers are recognized for manufacturing flavoxate hydrochloride at scale:

Mccoy Laboratories: Based in Mumbai, Mccoy Laboratories supplies flavoxate hydrochloride APIs to both domestic and international markets. Their facilities are GMP-certified, and they have a reputation for high-quality synthesis processes that meet US FDA and EMA standards.
Granules India Limited: Located in Hyderabad, Granules India produces a broad range of APIs, including flavoxate hydrochloride, supplying both generic and branded products. Their factory is approved by multiple regulatory agencies and emphasizes rigorous quality controls.
Aarti Industries: With operations in Maharashtra, Aarti Industries manufactures APIs for various therapeutic areas and holds export certifications. They have invested in quality control measures aligned with global standards, ensuring consistent supply.

2. Chinese API Manufacturers

China’s API manufacturing sector has expanded significantly, driven by cost competitiveness and technological advancements:

Hengyang City PPB Pharmaceutical Co., Ltd.: Specializes in synthesizing flavoxate hydrochloride, offering bulk API supplies exported worldwide. Their facilities are GMP-certified, with a focus on quality assurance.
Shandong Xinhua Pharmaceutical Co., Ltd.: A well-established manufacturer producing flavoxate hydrochloride APIs, with export permits to Europe, North America, and other regions.

3. European and North American Suppliers

While less prevalent given higher production costs, some European and North American firms produce flavoxate hydrochloride or import APIs for finished dosage manufacturing:

Mundipharma (Europe): This German-based pharmaceutical company sources flavoxate hydrochloride APIs from certified Asian manufacturers but maintains stringent quality standards for finished products.
Pfizer Inc. / Teva Pharmaceuticals (North America): These companies typically do not manufacture flavoxate hydrochloride but source APIs from approved third-party suppliers to meet regional demand for finished formulations.

Key Factors in Supplier Selection

When sourcing flavoxate hydrochloride, pharmaceutical companies consider multiple factors:

Regulatory Compliance: Suppliers must hold approvals from agencies such as the FDA, EMA, or PMDA, verifying adherence to GMP.
Quality Assurance: Consistency in API quality, as verified through batch testing, purity levels, and impurity profiles, is non-negotiable.
Manufacturing Capacity: Suppliers with scalable production capabilities ensure reliable supply and flexibility to meet demand fluctuations.
Cost and Lead Times: Competitive pricing coupled with short lead times influences procurement decisions, especially in a competitive API market.
Traceability and Documentation: Robust documentation and traceability standards facilitate regulatory audits and quality control.

Regional Supply Trends and Challenges

Asia-Pacific Dominance

India and China together dominate the flavoxate hydrochloride API market, primarily due to their manufacturing scale and lower costs. This regional concentration presents supply chain vulnerabilities related to geopolitical tensions, trade policies, and logistical disruptions.

Regulatory Hurdles

Stringent compliance requirements and quality standards across major markets necessitate continuous validation and monitoring of suppliers. Suppliers certified under international standards such as ISO 9001, WHO-GMP, and US FDA are preferred.

Supply Chain Risks

Dependence on Asian API manufacturers has increased concerns over geopolitical issues, tariffs, and supply chain bottlenecks post-pandemic. Diversification of suppliers across regions is increasingly adopted to mitigate risk.

Emerging Suppliers and Innovation in Supply Chain

The pharmaceutical industry is exploring alternative sourcing models, including:

Vertical Integration: Pharmaceutical firms are investing in proprietary manufacturing facilities for flavoxate hydrochloride to ensure supply security.
Partnerships with Contract Manufacturing Organizations (CMOs): Collaborations enable access to high-quality APIs without the need for significant capital expenditure.
Development of Non-Asian Suppliers: Regulatory agencies and industry consortia promote the development of API manufacturing in North America and Europe to diversify the supply base.

Conclusion

The supply chain for flavoxate hydrochloride hinges predominantly on Indian and Chinese API manufacturers, characterized by robust production capacity, cost competitiveness, and compliance with international standards. Key players such as Mccoy Laboratories, Granules India, and Hengyang City PPB Pharmaceutical play leading roles in the global marketplace. Addressing supply chain vulnerabilities involves strategic supplier diversification, rigorous compliance screening, and ongoing quality assurance.

Key Takeaways

The global supply of flavoxate hydrochloride APIs is heavily concentrated in India and China, necessitating diversified sourcing strategies to mitigate geopolitical and logistical risks.
Regulatory compliance, including GMP certification and quality assurance protocols, remains the foremost criterion in supplier selection.
Emerging trends favor vertical integration and partnerships with CMOs to enhance supply security and quality control.
Regulatory bodies are advocating for increased API manufacturing in North America and Europe to improve supply chain resilience.
Ongoing monitoring and validation of supplier capabilities, combined with strategic inventory management, are crucial for uninterrupted availability of flavoxate hydrochloride.

FAQs

1. What are the primary regions producing flavoxate hydrochloride APIs?
India and China are the leading regions, with multiple GMP-certified manufacturers supplying global markets.

2. How can pharmaceutical companies ensure supplier quality for flavoxate hydrochloride?
By selecting suppliers with international GMP certifications, performing regular audits, and reviewing batch validation data.

3. Are there alternative sources for flavoxate hydrochloride?
Yes, Europe and North America have emerging suppliers and CMOs capable of producing high-quality APIs, though they are less prevalent.

4. What risks are associated with regional concentration of flavoxate hydrochloride suppliers?
Supply disruptions due to geopolitical tensions, trade restrictions, or natural disasters can impact availability.

5. What trends are shaping the future sourcing strategies for flavoxate hydrochloride?
Diversification of supply bases, investment in proprietary manufacturing, and increased production in non-Asian regions are key trends.

Sources:
[1] Generic and branded API manufacturer disclosures, industry reports, and regulatory filings.
[2] International pharmaceutical regulatory agency guidelines (WHO, FDA, EMA).
[3] Industry market analyses and recent supply chain trend reports.

Suppliers and packagers for generic pharmaceutical drug: FLAVOXATE HYDROCHLORIDE