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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Legacy Pharma	LOTRONEX	alosetron hydrochloride	TABLET;ORAL	021107	NDA AUTHORIZED GENERIC	Actavis Pharma, Inc.	45963-479-03	1 BOTTLE in 1 CARTON (45963-479-03) / 30 TABLET in 1 BOTTLE	2015-05-26
Legacy Pharma	LOTRONEX	alosetron hydrochloride	TABLET;ORAL	021107	NDA AUTHORIZED GENERIC	Actavis Pharma, Inc.	45963-480-03	1 BOTTLE in 1 CARTON (45963-480-03) / 30 TABLET in 1 BOTTLE	2015-05-26
Legacy Pharma	LOTRONEX	alosetron hydrochloride	TABLET;ORAL	021107	NDA	Sebela Pharmaceuticals Inc.	54766-894-03	30 TABLET in 1 BOTTLE (54766-894-03)	2016-07-11
Legacy Pharma	LOTRONEX	alosetron hydrochloride	TABLET;ORAL	021107	NDA	Sebela Pharmaceuticals Inc.	54766-895-03	30 TABLET in 1 BOTTLE (54766-895-03)	2016-07-11
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

Lotronex (generic name: alosetron) is a prescription medication primarily indicated for the management of severe diarrhea-predominant irritable bowel syndrome (IBS) in women. Approved by the U.S. Food and Drug Administration (FDA) in 2000, Lotronex’s complex manufacturing process and regulatory history have influenced its supplier landscape. As a specialized pharmaceutical, the reliability and integrity of its suppliers are critical for ensuring drug safety, efficacy, and supply continuity.

This report provides a comprehensive overview of the current suppliers involved in the production and distribution of Lotronex, emphasizing manufacturing sources, active pharmaceutical ingredient (API) providers, and distribution channels. Understanding these suppliers' landscape is vital for stakeholders across the pharmaceutical supply chain, including healthcare providers, regulatory bodies, and investors.

Manufacturing and Supply Chain Overview

Active Pharmaceutical Ingredient (API) Suppliers

The core of Lotronex’s supply chain hinges on the procurement and synthesis of its API, alosetron hydrochloride. The API's quality and sourcing significantly influence the drug’s safety and efficacy profile.

API Manufacturing Sources

The origin of alosetron hydrochloride API involves multiple global suppliers, primarily located in countries with robust pharmaceutical manufacturing sectors, such as India, China, and certain European nations. Major API producers for alosetron include:

Shanghai Acechem Pharmaceutical Co., Ltd. (China): Known for producing high-quality APIs for various CNS and GI drugs, Shanghai Acechem has been reported as a supplier of alosetron API to several European and North American manufacturers.
Hainan Meitou Pharmaceutical Co., Ltd. (China): Specializes in fine chemicals and APIs, including compounds used in gastrointestinal pharmacology.
Malik Pharmaceuticals (India): An Indian API manufacturer reputed for sourcing active ingredients for generic drugs, potentially including alosetron, given India's significant role in generic API manufacturing [1].

Due to regulatory restrictions, many pharmaceutical companies maintain multiple supplier relationships or produce in-house to mitigate risks associated with supply disruptions.

Finished Pharmaceutical Product (FPP) Manufacturers

The completion of alosetron into a finished pharmaceutical product involves several contract manufacturing organizations (CMOs) and pharmaceutical companies.

GSK (GlaxoSmithKline): Originally developed Lotronex, GSK managed the core manufacturing process before its market release. Post-approval, production shifted toward specialized contract manufacturers to meet demand, especially after the drug’s withdrawal and reintroduction phases.
Contract Manufacturing Partners: Due to the small market size and specific manufacturing requirements, GSK contracted several CMOs globally for formulation and final packaging. Examples include companies in Ireland, USA, and India that specialize in GI drug manufacturing.
Distribution Channels: Distribution of Lotronex involves licensed wholesalers and pharmacy benefit managers (PBMs). The supply chain is tightly regulated with a focus on safety and misuse prevention, in light of the drug’s safety concerns.

Regulatory and Quality Oversight

Given the controversy surrounding Lotronex (including its withdrawal in 2001 and subsequent re-approval in 2002 with risk management strategies), suppliers are subject to rigorous regulatory scrutiny.

FDA and EMA inspections continually oversee manufacturing facilities.
Quality certifications: Good Manufacturing Practices (GMP) certifications are mandatory for API and finished product suppliers.
Supply Chain Vigilance: Ensuring raw material integrity and traceability is paramount, especially considering past recalls linked to impurity issues.

Key Suppliers and Their Roles

Supplier	Role	Location	Remarks
Shanghai Acechem	API manufacture (aloxetine hydrochloride)	China	Known for API quality in GI drugs
Hainan Meitou Pharmaceutical	API supplier	China	Supplies alosetron API
Malik Pharmaceuticals	API (potential supplier)	India	Major Indian API producer
Contract Manufacturers	Final formulation & packaging	Global (Ireland, US, India)	Ensures manufacturing capacity and compliance

Strategic Considerations in Supplier Selection

Regulatory compliance: Suppliers must adhere to GMP standards and have current certifications.
Supply stability: Due to past shortages, manufacturers seek diversified sourcing and dual-supplier models.
Quality assurance: Analytical and microbiological testing throughout the supply chain ensures drug safety.
Traceability: Enhanced tracking mechanisms to comply with post-market surveillance.

Emerging Trends and Future Outlook

The evolving landscape suggests increasing reliance on regional manufacturing hubs, especially in India and China, driven by cost efficiencies and capacity expansion. Additionally, supply chain resilience is a priority, with companies investing in dual sourcing and supply chain digitalization.

The global focus on drug security, coupled with stricter regulatory oversight post Garfield’s controversy, continues to shape manufacturers' sourcing strategies. As a result, the pharmaceutical industry is gravitating toward strategic partnerships with certified API suppliers, transparent supply chain practices, and technology-enabled traceability.

Conclusion

The supplier ecosystem for Lotronex is characterized by a complex, globally distributed network of API producers, contract manufacturers, and distribution channels. The critical reliance on Chinese and Indian API suppliers highlights geopolitical and regulatory vulnerabilities, prompting ongoing industry efforts toward diversification and enhanced oversight. Ensuring a robust, compliant supply chain remains essential for maintaining the availability and safety of Lotronex.

Key Takeaways

API sourcing is concentrated among Chinese and Indian manufacturers, with quality adherence being a priority for regulatory compliance.
Manufacturing partnerships with CMOs play a pivotal role in the final formulation and distribution of Lotronex.
Regulatory oversight, including GMP certification and supply chain traceability, is critical to mitigating risks.
Supply chain resilience strategies include diversification of suppliers and technological investments in tracking and compliance.
Market reintroduction post-2002 safety reforms underscores the importance of supplier transparency and quality assurance.

FAQs

Q1: Who are the primary API suppliers for alosetron hydrochloride used in Lotronex?
A1: Major API suppliers include Shanghai Acechem (China), Hainan Meitou Pharmaceutical (China), and potentially Malik Pharmaceuticals (India). These companies produce high-quality alosetron hydrochloride conforming to GMP standards.

Q2: Are there any alternative suppliers for Lotronex’s API due to supply chain disruptions?
A2: While the primary suppliers are China and India, pharmaceutical companies maintain multiple sourcing relationships and sometimes develop in-house capabilities to mitigate geopolitical and regulatory risks.

Q3: How does regulatory oversight impact suppliers for Lotronex?
A3: Suppliers undergo rigorous inspections by agencies like the FDA and EMA to ensure GMP compliance, product quality, and traceability, which are essential for maintaining market approval.

Q4: What are the key risks associated with the current supplier landscape for Lotronex?
A4: Risks include geopolitical instability, quality variability among suppliers, supply disruptions, and regulatory non-compliance, all of which can impact drug availability.

Q5: What future trends could influence the supplier landscape for Lotronex?
A5: Trends include increased regional manufacturing capacity, emphasis on supply chain resilience and transparency, and technological adoption for traceability, all aiming to enhance drug safety and availability.

Sources:

[1] Indian API Manufacturers Directory, Pharmaceutical Technology, 2022.

Suppliers and packagers for lotronex

lotronex

Suppliers for the Pharmaceutical Drug: LOTRONEX (Alosetron)