Suppliers and packagers for XANAX XR

XANAX XR

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Upjohn	XANAX XR	alprazolam	TABLET, EXTENDED RELEASE;ORAL	021434	NDA	Viatris Specialty LLC	58151-503-91	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (58151-503-91)	2024-05-21
Upjohn	XANAX XR	alprazolam	TABLET, EXTENDED RELEASE;ORAL	021434	NDA	Viatris Specialty LLC	58151-504-91	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (58151-504-91)	2024-06-20
Upjohn	XANAX XR	alprazolam	TABLET, EXTENDED RELEASE;ORAL	021434	NDA	Viatris Specialty LLC	58151-505-91	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (58151-505-91)	2024-08-01

Suppliers for the Pharmaceutical Drug: XANAX XR

Last updated: July 27, 2025

Introduction

XANAX XR, the extended-release formulation of alprazolam, is a widely prescribed medication for anxiety and panic disorders. Manufactured primarily by Pfizer, XANAX XR has a significant presence in global pharmaceutical markets. However, the drug's high demand, patent status, and market value have cultivated a complex landscape of suppliers, generic manufacturers, and authorized distributors. Understanding the supplier ecosystem for XANAX XR is vital for stakeholders involved in procurement, supply chain management, and strategic planning within the pharmaceutical industry.

1. Origin and Proprietary Status

Pfizer originally developed and marketed XANAX XR (alprazolam extended-release) under the brand name "XANAX XR." The drug's patent protection—initially granted in the United States—provided Pfizer with market exclusivity, limiting the entry of generic equivalents during that period. The patent expiry facilitated the emergence of generic manufacturers, expanding the supplier base globally.

2. Pfizer’s Role as an Authorized Supplier

Pfizer remains the primary authorized supplier of XANAX XR, controlling the manufacturing and distribution rights through licensing agreements. The company ensures quality compliance and regulatory adherence as per the Food and Drug Administration (FDA) standards [1]. Pfizer’s manufacturing facilities in the United States and abroad produce both branded and authorized generic versions of alprazolam extended-release formulations.

3. Generic Manufacturers and Market Dynamics

Post-patent expiration, multiple companies have become suppliers of generic XANAX XR. These manufacturers produce bioequivalent formulations that meet regulatory approval requirements, such as Abbreviated New Drug Applications (ANDAs) filed with the FDA. Prominent generic suppliers include:

• Teva Pharmaceuticals: As one of the world's largest generic drug manufacturers, Teva produces alprazolam extended-release formulations approved by the FDA. Their manufacturing facilities in Israel and the United States adhere to cGMP (current Good Manufacturing Practice) standards [2].

• Mylan (now part of Viatris): Mylan has a significant portfolio of generic CNS drugs, including alprazolam XR, approved by the FDA. They supply to various global markets, leveraging extensive distribution networks.

• Sun Pharmaceutical Industries: An Indian-based pharmaceutical company, Sun Pharma holds multiple ANDAs for alprazolam XR, enabling them to distribute in North America, Europe, and Asia.

• Sandoz/Sandoz International (a Novartis division): Produces generic versions of alprazolam XR, offering an alternative source in several regions.

The proliferation of generic manufacturers has increased supply options, driving down prices and expanding access but also raising concerns around counterfeit risks and supply chain integrity [3].

4. Regional Variants and Local Suppliers

In addition to global players, regional pharmaceutical firms often manufacture locally approved versions of alprazolam XR. These include companies in Europe, India, China, and Latin America. Regulatory differences influence the approval and distribution of these local suppliers.

5. Authorized Distributors and Supply Chain Participants

Authorized distributors function as intermediaries, ensuring the logistics of raw materials and finished products. Large pharmaceutical distribution networks, such as McKesson, Cardinal Health, and AmerisourceBergen, carry XANAX XR products from Pfizer and authorized generic manufacturers to pharmacies and healthcare providers.

Amid global supply chain disruptions, many stakeholders rely on strategic partnerships with these distributors to secure consistent supply—particularly in regions with complex regulatory environments or less mature manufacturing infrastructure [4].

6. Quality Assurance and Regulatory Oversight

Suppliers for XANAX XR must comply with stringent regulatory standards, including FDA, EMA, or equivalent authorities’ guidelines. The presentation of bioequivalence data, manufacturing practices, and pharmacovigilance is crucial. Unauthorized or counterfeit suppliers pose risks such as substandard efficacy and safety concerns.

7. Market Challenges and Supply Landscape Evolution

Patent challenges, regulatory changes, and market dynamics continually reshape the supplier landscape. The entry of biosimilar and generic competitors has led Pfizer to phase out certain branded formulations or enter licensing agreements to maintain market presence. Suppliers now face pressures related to quality control, intellectual property rights, and meeting demand in emerging markets.

Conclusion

The supply ecosystem for XANAX XR involves a combination of original innovator Pfizer, authorized generic manufacturers, regional local suppliers, and distribution channels. The landscape reflects typical post-patent market dynamics: increased competition, diversification of suppliers, and heightened regulatory scrutiny. Stakeholders must ensure quality assurance, supply chain resilience, and compliance to mitigate risks associated with counterfeit products and supply disruptions.

---

Key Takeaways

• Pfizer remains the primary authorized supplier of XANAX XR, maintaining manufacturing and distribution control.
• Post-patent expiration, numerous generic manufacturers—Teva, Mylan (Viatris), Sun Pharma, and Sandoz—are key suppliers, expanding availability globally.
• Regulatory compliance and quality assurance are central to supplier credibility—licensed manufacturers adhere to strict standards.
• Regional manufacturers and local distributors augment supply in specific markets, driven by regulatory approvals and demand.
• Supply chain resilience hinges on strategic partnerships with authorized distributors and adherence to quality and regulatory standards.

---

FAQs

1. Who are the main suppliers of XANAX XR on the global market?
The primary suppliers include Pfizer (original manufacturer), Teva Pharmaceuticals, Mylan (Viatris), Sun Pharma, and Sandoz. These companies produce bioequivalent generic versions approved by regulatory agencies such as the FDA.

2. How does patent expiry affect the supply of XANAX XR?
Patent expiry allows generic manufacturers to produce bioequivalent formulations, diversifying the supplier base, reducing prices, and increasing access. It also prompts brand manufacturers to innovate or license or transfer markets.

3. Are there risks associated with unapproved or counterfeit suppliers of XANAX XR?
Yes. Counterfeit or unapproved sources can provide substandard or unsafe products, posing health risks and regulatory sanctions. Supply chain vigilance and purchasing only from authorized distributors are essential.

4. What regulatory standards govern the manufacturing of XANAX XR suppliers?
Manufacturers adhere to standards such as the FDA's Good Manufacturing Practices (cGMP), which set specifications for production, quality control, and safety. Regional regulatory agencies like EMA or MHRA impose similar standards.

5. How can healthcare providers ensure consistent supply of XANAX XR?
By partnering with reputable distributors, maintaining diversified supplier relationships, and monitoring supply chain stability, providers can mitigate shortages and ensure patient access.

---

References

[1] Pfizer. XANAX XR Prescribing Information. 2022.
[2] FDA. Abbreviated New Drug Applications (ANDA) Database. 2023.
[3] IMS Health. Global Generic Drug Market Analysis. 2022.
[4] McKesson. Supply Chain Solutions for pharmaceuticals. 2023.