Suppliers and packagers for xenical

xenical

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cheplapharm	XENICAL	orlistat	CAPSULE;ORAL	020766	NDA	H2-Pharma LLC	61269-460-90	90 CAPSULE in 1 BOTTLE, PLASTIC (61269-460-90)	2010-12-17
Cheplapharm	XENICAL	orlistat	CAPSULE;ORAL	020766	NDA AUTHORIZED GENERIC	H2-Pharma LLC	61269-565-90	90 CAPSULE in 1 BOTTLE, PLASTIC (61269-565-90)	2022-06-01

Last updated: July 31, 2025

ppliers for the Pharmaceutical Drug: XENICAL

Introduction

Xenical, the brand name for orlistat, is a widely prescribed oral weight-loss medication primarily used to promote weight reduction by inhibiting fat absorption in the gastrointestinal tract. It is produced by established pharmaceutical companies and distributed globally through a network of primary and secondary suppliers. Understanding the spectrum of suppliers involved in Xenical's supply chain is integral for stakeholders—ranging from healthcare providers to investors—seeking insights into market dynamics, supply reliability, and regulatory compliance.

Manufacturers of Xenical

The primary manufacturer of Xenical (orlistat) is F. Hoffmann-La Roche Ltd., a Swiss multinational pharmaceutical company. Roche developed and initially marketed Xenical in 1997, establishing it as one of the first FDA-approved anti-obesity medications. The company operates manufacturing facilities responsible for the active pharmaceutical ingredient (API) production, formulation, and packaging processes.

In recent years, Roche has shifted its focus towards biosimilars and oncology, leading to strategic negotiations with third-party contract manufacturing organizations (CMOs) to handle aspects of production and distribution. Despite this, Roche remains the key innovator and sole proprietary supplier for the original Xenical formulation.

Contract Manufacturing and Contract Development Organizations (CDMOs)

To meet global demand, Roche and other stakeholders leverage CDMOs. These organizations supply intermediates, APIs, and finished formulations compliant with Good Manufacturing Practices (GMP). Notable CDMOs involved in orlistat manufacturing include:

• Lonza: A Swiss-innovative biopharma and chemical supplier, involved in specialty chemical synthesis, including intermediates for APIs.
• Evonik Industries: German specialty chemicals manufacturer, reportedly engaged in fine chemicals and pharmaceutical ingredient synthesis.
• Samsung Biologics and Celltrion: While primarily focused on biologics, these firms exemplify the trend of outsourcing manufacturing to reliable CDMOs capable of scaling production.

However, specific proprietary data on CDMOs producing orlistat remains confidential due to competitive and regulatory considerations.

Supply Chain and Distribution Channels

Once produced, Xenical is distributed through various channels globally. Key suppliers include:

• Wholesalers and Distributors: Major pharmaceutical wholesalers such as McKesson, AmerisourceBergen, and Cardinal Health in the US serve as primary distribution hubs for pharmacies and hospitals.
• Pharmacies and Healthcare Providers: Prescription fulfillment depends on licensed pharmacies, which source Xenical directly from wholesalers.
• Regulatory Agencies: Agencies like the FDA (U.S.), EMA (Europe), and other national authorities regulate import, distribution, and manufacturing standards, ensuring safety and compliance.

These channels ensure the supply chain's integrity, maintaining availability in retail and institutional settings.

Regional Suppliers and Generic Manufacturers

Post patent expiry in 2010, generic versions of orlistat have entered markets worldwide, broadening the supplier base. Generic manufacturers often produce orlistat under different brand names or as unbranded generics, including:

• Teva Pharmaceutical Industries (Israel): A major producer of generic medicines, including orlistat formulations.
• Mylan (now part of Viatris): Offers cost-effective generic orlistat, distributed globally.
• Sandoz (Novartis): Manufacturer of numerous generics in Europe and other regions, likely to produce orlistat for regional markets.
• Cipla and Sun Pharma: Prominent Indian generic drug manufacturers supplying cost-efficient formulations to emerging markets.

These generic suppliers often source APIs from low-cost manufacturing regions, including China and India, which house several API manufacturers capable of producing orlistat at scale.

API Suppliers

The API for Xenical, orlistat, is complex to manufacture, involving multi-step synthesis with high purity standards. Leading API producers include:

• Hikal Ltd. (India): An active player in the synthesis of pharmaceutical intermediates and APIs.
• Shanghai Chemlink Chemicals (China): Specialized in pharmaceutical chemicals and intermediates, including APIs like orlistat.
• BASF (Germany): While more focused on chemical intermediates, BASF possesses capabilities in complex API synthesis.

Given widespread global API manufacturing, quality, regulatory compliance, and supply stability are paramount factors influencing the end-market availability of Xenical formulations.

Regulatory and Patent Considerations

Since the original patent protections expired in multiple jurisdictions, generic manufacturers have entered the market, increasing supply diversity. Nonetheless, Roche maintains exclusive rights in certain regions through patents and regulatory exclusivities, influencing regional supply landscapes. Regulatory authorities like FDA and EMA stipulate strict manufacturing standards, which suppliers must adhere to, impacting their eligibility to participate in Xenical’s global distribution.

Market and Supply Dynamics

The global Xenical supply chain has evolved significantly, with increased reliance on regional and generic suppliers post-patent expiry. Price competition among generics has driven down costs but introduced concerns over quality and supply consistency. Roche sustains high standards through rigorous CMO audits and compliance checks, ensuring product integrity.

Supply chain disruptions, whether due to geopolitical issues, pandemics, or raw material shortages—particularly in regions like China and India—pose ongoing risks. Strategies to mitigate such risks involve diversified supplier bases, regional manufacturing hubs, and inventory management.

Future Outlook

Given the market saturation with generics and biosimilars, future supply will likely depend on:

• Regulatory landscape adaptations: Patent litigations and regulatory exclusivities will shape market access.
• Manufacturing innovation: Improvements in API synthesis could lead to more efficient production and lower costs.
• Supply chain resilience: Diversification of API and formulation manufacturing hubs to improve agility and robustness.

Key Takeaways

• Roche remains the primary innovator and original supplier for Xenical, relying on a network of CMOs for manufacturing.
• Post-patent expiry, a broad spectrum of generic manufacturers, notably in India and China, supplies the drug globally.
• API suppliers include companies like Hikal and Shanghai Chemlink, with stringent quality controls essential for market access.
• The supply chain’s complexity underscores the importance of regulatory compliance, quality assurance, and diversified sourcing to mitigate disruptions.
• Strategic partnerships and ongoing manufacturing innovations will shape the future availability of Xenical.

FAQs

1. Who is the primary manufacturer of Xenical?
F. Hoffmann-La Roche Ltd. is the original and primary manufacturer, responsible for the development, marketing, and formulation of Xenical globally.

2. Are there generic versions of Xenical?
Yes. Several generic manufacturers, including Teva, Mylan, Sandoz, Cipla, and Sun Pharma, produce and distribute orlistat formulations following patent expiration in various markets.

3. Where are the APIs for Xenical primarily sourced?
APIs are mainly sourced from China and India, with companies like Shanghai Chemlink and Hikal leading in manufacturing and supplying pharmaceutical-grade orlistat intermediates and APIs.

4. How do supply chain disruptions impact Xenical availability?
Disruptions caused by geopolitical issues, raw material shortages, or regulatory lapses can lead to shortages, impacting patient access and pricing. Diversification of suppliers mitigates these risks.

5. What are future trends for Xenical supply?
Enhanced manufacturing efficiency, increased regional production, and strategic regulatory navigation are expected to influence the stability and cost of Xenical supply in the coming years.

References

[1] Roche Official Website (2023). Xenical Overview.
[2] U.S. Food and Drug Administration (FDA). Orlistat (Xenical) Approval Details.
[3] Market Data Reports. Generic Pharmaceutical Market Share Analysis (2022).
[4] Major API Production Reports. Pharmaceutical API Market Analysis (2022).
[5] Industry News. Covid-19 Impact on Pharmaceutical Supply Chains.