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
Upjohn	XANAX XR	alprazolam	TABLET, EXTENDED RELEASE;ORAL	021434	NDA	Viatris Specialty LLC	58151-506-91	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (58151-506-91)	2024-07-26

XANAX XR (Alprazolam Extended-Release) Active Pharmaceutical Ingredient (API) and Key Excipient Suppliers

Last updated: February 19, 2026

This report details suppliers for the active pharmaceutical ingredient (API) alprazolam and key excipients used in the extended-release formulation of XANAX XR. The analysis focuses on established manufacturers and their historical involvement with the drug or its components, providing data for supply chain risk assessment and strategic sourcing.

Who Supplies Alprazolam API for XANAX XR?

The primary supplier of alprazolam API for XANAX XR is Pfizer Inc., the originator and current manufacturer of the branded drug. Pfizer manufactures alprazolam at its internal facilities. While generic manufacturers utilize third-party API suppliers, the specific API source for the branded XANAX XR is vertically integrated within Pfizer.

Generic versions of alprazolam extended-release products rely on a broader supplier base. Key manufacturers of alprazolam API include:

• Sun Pharmaceutical Industries Ltd.
• Dr. Reddy's Laboratories Ltd.
• Teva Pharmaceutical Industries Ltd.

These companies are significant global producers of APIs and are known to supply alprazolam for various formulations. The specific supplier for any given generic product will vary based on manufacturing agreements and regulatory filings.

What Excipients Are Critical for XANAX XR Formulation?

XANAX XR (alprazolam extended-release tablets) relies on specific excipients to control the release rate of alprazolam. The formulation utilizes a matrix system where the API is embedded within an inert carrier that slowly dissolves or erodes, releasing the drug over time. Key excipients identified in the formulation include:

• Hypromellose (Hydroxypropyl Methylcellulose - HPMC): This is a primary component of the extended-release matrix. It controls drug release through swelling and erosion mechanisms. Different viscosity grades of HPMC are used to achieve precise release profiles.

  • Supplier Landscape: Major global manufacturers of HPMC include:
    • Ashland Global Holdings Inc. (e.g., Methocel™ grades)
    • Dow Inc. (e.g., E-series grades)
    • Shin-Etsu Chemical Co., Ltd.

• Lactose Monohydrate: Often used as a filler and diluent in tablet formulations. Its properties influence tablet compressibility and dissolution.

  • Supplier Landscape: Widely sourced from dairy processors. Prominent suppliers include:
    • DMV-Fonterra Excipients B.V. (now part of FrieslandCampina Ingredients)
    • Lactose (India) Limited
    • Foremost Ingredients

• Magnesium Stearate: Acts as a lubricant, preventing the tablet formulation from sticking to manufacturing equipment during the compression process.

  • Supplier Landscape: Several chemical manufacturers produce pharmaceutical-grade magnesium stearate. Key suppliers include:
    • Norwegian Fish Oil AS
    • Peter Cremer GmbH & Co. KG
    • Ferro Corporation (now part of Prince International Corporation)

• Colloidal Silicon Dioxide (Silica): Used as a glidant to improve powder flow properties during tablet manufacturing and as an anti-caking agent.

  • Supplier Landscape: Major producers of fumed silica include:
    • Evonik Industries AG (e.g., Aerosil® grades)
    • Cabot Corporation

The specific grades and specifications of these excipients are critical. For XANAX XR, the precise molecular weight, viscosity (for HPMC), particle size distribution, and purity of each excipient are engineered to achieve the target 24-hour extended release profile. Changes in excipient suppliers, even for equivalent grades, can necessitate revalidation of the formulation's performance and regulatory review.

What Are the Regulatory Considerations for XANAX XR Suppliers?

Suppliers for XANAX XR, both API and excipients, are subject to stringent regulatory oversight. Key considerations include:

• Good Manufacturing Practices (GMP): All manufacturing facilities must comply with current GMP regulations as defined by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other national regulatory bodies.
• Drug Master Files (DMFs): API suppliers typically maintain DMFs with regulatory agencies. These confidential documents contain detailed information about the manufacturing process, facility, quality control, and stability of the API. Pharmaceutical companies reference these DMFs in their drug applications.
• Excipient Standards: Excipients must meet pharmacopoeial standards, such as those outlined in the United States Pharmacopeia (USP) or the European Pharmacopoeia (Ph. Eur.). Manufacturers must provide Certificates of Analysis (CoAs) confirming compliance with these standards.
• Change Control: Any change in an API or critical excipient supplier, manufacturing site, or manufacturing process requires notification to the regulatory authorities and may necessitate significant revalidation studies and regulatory filings, including amendments to Abbreviated New Drug Applications (ANDAs) for generics.
• Supply Chain Security: Manufacturers are responsible for ensuring the integrity and security of their supply chain to prevent counterfeiting and contamination.

The originator, Pfizer, maintains direct control over its API and excipient sourcing for XANAX XR. Generic manufacturers, however, must navigate the complexities of qualifying and managing multiple third-party suppliers to ensure consistent quality and regulatory compliance. The selection of excipient grades and suppliers is particularly crucial for achieving the bioequivalence required for generic approval.

How Does Supply Chain Concentration Impact XANAX XR?

The supply chain for XANAX XR, particularly the alprazolam API, exhibits a moderate to high degree of concentration.

• API Concentration: Pfizer is the sole producer of alprazolam API for the branded product. For generic markets, while multiple API manufacturers exist (Sun Pharma, Dr. Reddy's, Teva being prominent), the global capacity and regulatory approval status for each can create bottlenecks. A disruption at a major API manufacturer could impact the availability of multiple generic alprazolam extended-release products.
• Excipient Concentration: While excipients like lactose, magnesium stearate, and colloidal silicon dioxide have a broader supplier base, specific pharmaceutical grades of hypromellose with controlled viscosity profiles can be concentrated among a few specialized manufacturers. A disruption at a key HPMC supplier could significantly impact the manufacturing of extended-release formulations across the pharmaceutical industry, including generic alprazolam.

This concentration necessitates robust risk mitigation strategies for pharmaceutical companies. Dual sourcing, qualification of alternate suppliers, and maintaining adequate inventory levels are critical measures to ensure uninterrupted supply of XANAX XR and its generic equivalents. The cost implications of qualifying new suppliers and the time required for regulatory approval of changes further underscore the importance of long-term supplier relationships and proactive supply chain management.

Key Takeaways

• Pfizer Inc. is the sole supplier of alprazolam API for branded XANAX XR, manufactured internally.
• Generic alprazolam extended-release products source API from manufacturers including Sun Pharmaceutical Industries Ltd., Dr. Reddy's Laboratories Ltd., and Teva Pharmaceutical Industries Ltd.
• Critical excipients for XANAX XR's extended-release matrix include hypromellose (HPMC), lactose monohydrate, magnesium stearate, and colloidal silicon dioxide.
• Major HPMC suppliers are Ashland Global Holdings Inc., Dow Inc., and Shin-Etsu Chemical Co., Ltd.
• Suppliers must adhere to stringent GMP regulations, maintain DMFs for APIs, and meet pharmacopoeial standards for excipients.
• Regulatory approval is required for any changes in API or critical excipient suppliers.
• Supply chain concentration exists for alprazolam API and specialized pharmaceutical grades of HPMC, posing potential risks to uninterrupted supply.

Frequently Asked Questions

1. What is the primary mechanism by which XANAX XR achieves extended release? XANAX XR utilizes a matrix system, where alprazolam is embedded within an inert carrier, typically hypromellose (HPMC). This matrix controls drug release through swelling and subsequent erosion over a 24-hour period.

2. Can generic XANAX XR formulations use API from different suppliers than the branded product? Yes, generic manufacturers must source alprazolam API from approved suppliers. These suppliers are listed in regulatory filings and must meet pharmacopoeial and GMP standards.

3. What impact does changing an excipient supplier have on a generic alprazolam extended-release product? Changing an excipient supplier, even for a product with an equivalent grade, can affect the drug release profile, bioavailability, and overall performance of the generic product. Regulatory submission and approval are required for such changes.

4. Are there any single-source critical excipients for the XANAX XR formulation? While several excipients have multiple suppliers, specific pharmaceutical grades of hypromellose (HPMC) with tightly controlled viscosity and molecular weight characteristics necessary for extended-release matrices can be concentrated among a limited number of global manufacturers.

5. What steps are typically taken to mitigate supply chain risks for critical pharmaceutical ingredients like those used in XANAX XR? Mitigation strategies include dual sourcing for critical raw materials, qualifying alternate manufacturing sites, maintaining strategic inventory levels, and establishing strong, long-term relationships with key suppliers to ensure supply continuity and facilitate rapid response to disruptions.

Citations

[1] U.S. Food & Drug Administration. (n.d.). Drug Master Files (DMFs). Retrieved from [FDA Website]

[2] United States Pharmacopeia. (n.d.). USP-NF General Chapters.

[3] European Medicines Agency. (n.d.). Guideline on the quality of new drug products.

[4] Pfizer Inc. Annual Reports. (Various Years). [Publicly available financial and operational reports].

[5] Sun Pharmaceutical Industries Ltd. Investor Presentations and Annual Reports. (Various Years). [Publicly available financial and operational reports].

[6] Dr. Reddy's Laboratories Ltd. Investor Presentations and Annual Reports. (Various Years). [Publicly available financial and operational reports].

[7] Teva Pharmaceutical Industries Ltd. Investor Presentations and Annual Reports. (Various Years). [Publicly available financial and operational reports].

[8] Ashland Global Holdings Inc. Product Information and Technical Data Sheets. [Manufacturer websites and product literature].

[9] Dow Inc. Product Information and Technical Data Sheets. [Manufacturer websites and product literature].

[10] Shin-Etsu Chemical Co., Ltd. Product Information and Technical Data Sheets. [Manufacturer websites and product literature].