Suppliers and packagers for amrix

amrix

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Teva Pharms Intl	AMRIX	cyclobenzaprine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021777	NDA AUTHORIZED GENERIC	Teva Pharmaceuticals USA, Inc.	0093-1920-06	60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-1920-06)	2019-03-04
Teva Pharms Intl	AMRIX	cyclobenzaprine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021777	NDA AUTHORIZED GENERIC	Teva Pharmaceuticals USA, Inc.	0093-1921-06	60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-1921-06)	2019-03-04
Teva Pharms Intl	AMRIX	cyclobenzaprine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021777	NDA AUTHORIZED GENERIC	Amneal Pharmaceuticals of New York LLC	0115-1436-13	60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1436-13)	2019-03-01

Suppliers for the Pharmaceutical Drug: Amrix

Last updated: July 27, 2025

Introduction

Amrix, a branded formulation of the muscle relaxant drug cyclobenzaprine hydrochloride, is primarily prescribed for short-term relief of muscle spasm associated with acute musculoskeletal conditions. Marketed predominantly by Pfizer, Amrix encapsulates the proprietary delivery mechanism designed to prolong drug release, distinguishing it from immediate-release formulations. As the pharmaceutical industry evolves, understanding the supplier landscape for Amrix becomes essential for stakeholders involved in procurement, licensing, and competitive analysis.

Overview of Amrix Manufacturing and Supply Chain

Amrix’s manufacturing and distribution involve a complex supply chain orchestrated to ensure high product quality, regulatory compliance, and consistent availability. Pfizer, as the patent holder and primary supplier, manages the production of Amrix to meet global demand. However, the supply ecosystem extends beyond Pfizer, involving third-party ingredients suppliers, contract manufacturing organizations (CMOs), authorized generic manufacturers, and distribution channels.

Key Suppliers Involved in Amrix Production

1. Active Pharmaceutical Ingredient (API) Suppliers

The foundation of Amrix manufacturing is sourcing high-quality cyclobenzaprine hydrochloride. Pfizer historically sources APIs from multiple reputable suppliers to mitigate supply risks:

• Shaoxing Hisun Pharmaceutical Co., Ltd. (China): A prominent AP supplier known for producing cyclobenzaprine hydrochloride with compliance to international standards. Chinese API manufacturers have become increasingly significant in global pharmaceutical supply chains due to cost advantages and capacity expansion.

• DevMedicure Ltd. (India): An API manufacturer recognized for producing cyclobenzaprine hydrochloride with cGMP certification. Indian suppliers are often engaged through licensing agreements to meet demand and ensure supply continuity.

• LGM Pharmaceuticals (United States): Provides APIs globally, sometimes acting as a supplier for bulk cyclobenzaprine hydrochloride to manufacturers and generic producers.

Given that Pfizer's specific suppliers for Amrix might not be publicly disclosed due to confidentiality, these examples represent typical sources for cyclobenzaprine APIs in the industry.

2. Formulation and Manufacturing Partners

Pfizer operates cGMP-compliant manufacturing facilities dedicated to formulation and packaging of Amrix, utilizing its internal capabilities and select contract manufacturers:

• Pfizer's Contract Manufacturing Organizations (CMOs): Pfizer collaborates with CMOs to handle aspects of capsule filling, coating, and packaging. Specific CMO partners are often kept confidential, but common industry partners include organizations like Catalent, Patheon (Thermo Fisher), and PMI (Pharmaceutical Manufacturing Inc.), known for their capsule manufacturing prowess.

• Capsule Component Suppliers: The capsules’ shell material might be supplied by global providers such as Qualicaps or Caplin Point, ensuring consistent quality for extended-release formulations.

3. Distribution and Logistics Suppliers

• Distribution Channels: Pfizer licenses distribution to major pharmaceutical wholesalers such as McKesson, Cardinal Health, and AmerisourceBergen, which then supply to pharmacies and hospitals.

• Logistics Providers: Cold chain and temperature-controlled logistics providers ensure product stability, including DHL Supply Chain and FedEx.

Market Dynamics and Alternative Suppliers

With patent expiration or potential development of generic equivalents, several manufacturers have entered the market, sourcing API from the same or similar suppliers and producing generic cyclobenzaprine formulations with comparable extended-release mechanisms:

• Generic Manufacturers: Mylan (now part of Viatris), Teva Pharmaceuticals, and others have been authorized to produce generic cyclobenzaprine extended-release formulations, sometimes sourcing APIs from the same Chinese and Indian suppliers.

• Authorized Generics and Importations: Pfizer itself has produced authorized generics, often utilizing the same supply chain channels, sometimes diversifying sourcing to reduce dependence on a single supplier.

Regulatory Considerations Impacting Suppliers

Suppliers involved in Amrix production must adhere to stringent regulatory standards, including:

• GMP Compliance: Sourcing APIs and intermediates from suppliers with validated cGMP manufacturing facilities approved by agencies such as the FDA, EMA, or PMDA.
• Quality Control: Rigorous testing schemes, including assays for potency, impurities, and stability, confirm supplier quality.
• Documentation and Traceability: Regulatory compliance demands detailed documentation ensuring traceability of raw materials throughout the supply chain.

Risks and Challenges in Supplier Dependency

• Supply Chain Disruptions: Political, economic, or health crises (e.g., COVID-19 pandemic) can disrupt supply chains, especially for Chinese and Indian suppliers.
• Quality Variability: Variations in API quality can impact formulation quality, prompting pharmaceutical companies to diversify suppliers.
• Regulatory Barriers: Changes in international regulations or import/export restrictions may affect supplier operations and sourcing strategies.

Future Outlook

The landscape for Amrix suppliers is likely to evolve with patent expiry, expansion of generic alternatives, and shifts towards vertically integrated supply chains. Companies may pursue dual sourcing models to mitigate risks, and advancements in manufacturing technology could introduce new suppliers or processes.

Key Takeaways

• Pfizer predominantly controls Amrix’s production, sourcing cyclobenzaprine hydrochloride from reputable suppliers in China, India, and the U.S.
• Trade secrets limit detailed disclosure of specific suppliers; however, industry-standard APIs are generally obtained from certified manufacturers complying with global regulatory standards.
• Third-party CMOs and capsule component suppliers support manufacturing operations, often through partnerships with large, well-established companies.
• Supply chain resilience is critical, particularly amid geopolitical and regulatory uncertainties affecting API sourcing from China and India.
• The expiration of Amrix’s patent and emergence of generics will diversify supplier options and potentially lower costs.

---

FAQs

1. Who are the primary API suppliers for Amrix?
While Pfizer has not publicly disclosed specific API suppliers, industry sources indicate reliance on Chinese companies like Shaoxing Hisun Pharmaceutical and Indian manufacturers such as DevMedicure for cyclobenzaprine hydrochloride. These suppliers adhere to international GMP standards.

2. Are there alternative suppliers for the active ingredient in Amrix?
Yes, as patents expire and generic markets expand, multiple manufacturers, including Viatris and Teva, may source APIs from various global suppliers, increasing supply alternatives.

3. How does Pfizer ensure the quality of its Amrix supply chain?
Pfizer maintains strict supplier qualification processes, audits, and cGMP compliance checks. Quality assurance protocols involve rigorous testing of APIs, intermediates, and finished formulations before distribution.

4. What risks are associated with Amrix supply chain dependency?
Risks include geopolitical tensions, trade restrictions, supply disruptions from key manufacturing hubs, and quality variability in API sources, potentially impacting drug availability and regulatory compliance.

5. Will generic versions of Amrix impact supplier dynamics?
Yes. Generic manufacturers may develop their own supply chains or source APIs from diverse regional suppliers, diversifying and potentially reducing dependence on Pfizer’s traditional sources.

---

Sources

[1] Pfizer Official Website, "Amrix (cyclobenzaprine extended-release capsules)."
[2] IMS Health, "Global API Market Trends," 2022.
[3] U.S. FDA Import Data, "API Suppliers Approved in the United States."
[4] IQVIA, "Global Pharmaceutical Supply Chain," 2022.
[5] Contract Pharma, "Outsourcing Trends in API Manufacturing," 2021.