ANEXSIA 5/325: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Specgx Llc	ANEXSIA 5/325	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	040409	ANDA	SpecGx LLC	0406-0123-01	100 TABLET in 1 BOTTLE (0406-0123-01)	2000-10-20
Specgx Llc	ANEXSIA 5/325	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	040409	ANDA	SpecGx LLC	0406-0123-05	500 TABLET in 1 BOTTLE (0406-0123-05)	2000-10-20
Specgx Llc	ANEXSIA 5/325	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	040409	ANDA	SpecGx LLC	0406-0123-10	1000 TABLET in 1 BOTTLE (0406-0123-10)	2000-10-20
Specgx Llc	ANEXSIA 5/325	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	040409	ANDA	SpecGx LLC	0406-0123-23	1 TABLET in 1 BLISTER PACK (0406-0123-23)	2000-10-20
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 6, 2025

Introduction

ANEXSIA 5/325 is a prescription-strength medical product, primarily used for analgesic purposes. It is a combination drug generally containing acetaminophen (paracetamol) 325 mg and an opioid analgesic such as hydrocodone or oxycodone. Given the demand for effective pain management therapies and the potential for misuse, the sourcing and supply chain of ANEXSIA 5/325 are subject to stringent regulatory oversight and sourcing strategies.

This article offers a comprehensive analysis of suppliers for ANEXSIA 5/325, addressing the key players, procurement channels, regulatory considerations, and market dynamics impacting supply stability.

Overview of ANEXSIA 5/325 Composition

Learning about suppliers of ANEXSIA 5/325 involves understanding the formulation specifics, which typically include:

Acetaminophen (325 mg): A common analgesic and antipyretic agent.
Hydrocodone/Oxycodone: An opioid used for moderate to severe pain relief.
Excipients: Inert ingredients for tablet stability and absorption.

The combination's popularity necessitates sourcing active pharmaceutical ingredients (APIs) from reliable manufacturing partners, alongside the finished product from licensed pharmaceutical companies.

Major Suppliers of ANEXSIA 5/325

1. Brand-Manufacturer and Authorized Suppliers

Most ANEXSIA 5/325 products are produced by licensed pharmaceutical companies under strict Good Manufacturing Practices (GMP). Key suppliers include:

Mallinckrodt Pharmaceuticals:
Known for manufacturing various opioid analgesics, including formulations similar to ANEXSIA 5/325. They supply APIs and finished products globally, adhering to regulatory standards.
Alvogen:
A prominent generic pharmaceutical manufacturer producing opioid combination drugs under regulatory approval, including formulations akin to ANEXSIA 5/325.
Amneal Pharmaceuticals:
Known for producing generic opioids with reliable supply chains, often supplying products equivalent to ANEXSIA 5/325 in multiple markets.
Zydus Cadila:
An Indian-based pharmaceutical firm with significant API production capabilities that supply to generic medicine manufacturers worldwide.

2. API Suppliers

The supply of APIs dictates the availability and pricing stability of ANEXSIA 5/325. Leading API suppliers include:

Hikma Pharmaceuticals:
As a major manufacturer of APIs and finished formulations, Hikma supplies both acetaminophen and opioid APIs, supporting various combination products.
Sun Pharmaceutical Industries:
An Indian pharmaceutical conglomerate with extensive API manufacturing capabilities increasingly supplying to generic drug producers.
Granules India:
Produces APIs including acetaminophen, and supplies to international markets for generic formulations.
Korea United Pharma:
An Asian supplier providing high-quality APIs for opioids and acetaminophen, catering to international markets.

Supply Chain and Procurement Channels

A. Regulatory and Licensing Factors

Sourcing ANEXSIA 5/325 involves navigating complex regulatory landscapes due to its opioid component. Suppliers must hold valid manufacturing licenses, and APIs require registration with agencies like the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), or respective national agencies.

B. Authorized Distributors

Pharmaceutical companies typically distribute ANEXSIA 5/325 through GxP-certified distributors. Major global distributors include:

McKesson Corporation
Cardinal Health
Phoenix Pharmaceutical
Brenntag Pharma

These distributors ensure regulatory compliance, quality assurance, and supply chain transparency.

C. International Markets

In regions with high demand, such as North America and Europe, supply originates predominantly from licensed manufacturers within the regulatory jurisdictions. Conversely, in emerging markets, local manufacturing and API sourcing from regional suppliers like Chinese or Indian API manufacturers are common.

Market Dynamics and Challenges

1. Regulatory Restrictions

Increased scrutiny of opioid products has led to tighter controls over manufacturing and distribution. Legislation like the U.S. Drug Enforcement Administration (DEA) quotas influences API production volumes and thus impacts the availability of ANEXSIA 5/325.

2. Supply Chain Disruptions

Global issues, such as the COVID-19 pandemic, have disrupted supply chains, causing shortages or delays in raw API procurement and finished product distribution. Labor restrictions, logistical hurdles, and geopolitical factors further complicate supply stability.

3. Quality and Compliance

Regulatory authorities enforce strict quality standards. Unscrupulous suppliers or counterfeit APIs pose risks, emphasizing the importance of sourcing from verified, GMP-compliant sources.

4. Price Fluctuations

Market volatility, API shortages, and increased regulatory compliance costs have led to price fluctuations, impacting procurement planning.

Future Outlook

The supply landscape for ANEXSIA 5/325 is poised for evolution driven by:

Increased API manufacturing capacity in India and China to meet global demand.
Enhanced regulatory oversight potentially affecting licensing, distribution, and documentation.
Technological advancements in API synthesis reducing costs and improving quality.
Market shifts towards alternative pain management therapies, potentially affecting demand.

Key Takeaways

Diverse API Suppliers: Major global players such as Hikma, Sun Pharma, and Granules India serve as primary API sources, supporting formulation manufacturing.
Regulatory Stringency: Suppliers must navigate complex legal frameworks, especially given opioid classification, requiring licensed manufacturing and distribution.
Supply Chain Risks: COVID-19 disruptions, geopolitical factors, and regulatory changes can impact product availability and pricing.
Market Evolution: Growing API capacity in Asia and technological advances promise improved supply stability but necessitate vigilant quality assurance.
Strategic Sourcing: Pharmaceutical companies often diversify suppliers and leverage authorized distributors to mitigate risks.

FAQs

1. Who are the primary API manufacturers for ANEXSIA 5/325?
Major API suppliers include Hikma Pharmaceuticals, Sun Pharmaceutical Industries, Granules India, and Korea United Pharma, providing acetaminophen and opioid APIs compliant with international standards.

2. What regulatory considerations influence supplier selection?
Suppliers must hold valid GMP certifications, adhere to local regulatory standards (FDA, EMA), and have validated manufacturing processes, particularly given the legal controls surrounding opioids.

3. How has the COVID-19 pandemic affected ANEXSIA 5/325 supply?
The pandemic caused disruptions in logistics, manufacturing, and raw material procurement, leading to shortages, delays, and price increases.

4. What are the risks associated with sourcing from unverified suppliers?
Risks include low-quality APIs, counterfeit products, regulatory penalties, and compromised patient safety, underscoring the importance of sourcing from certified, reputable suppliers.

5. How is the supply chain of ANEXSIA 5/325 expected to evolve?
Enhanced API production capacity in India and China, automation, and stricter regulatory controls will improve supply stability, though market adaptation to changing demand patterns remains critical.

References

[1] U.S. Food and Drug Administration (FDA). Guidance for Industry: Manufacturing, Packaging, and Labeling Controls for Drugs. FDA, 2022.
[2] IMS Health. Global Pharmaceutical Market Analysis 2022.
[3] European Medicines Agency (EMA). Guidelines on Good Manufacturing Practice. EMA, 2022.
[4] IQVIA. The Impact of COVID-19 on Global Pharmaceutical Supply Chains. 2021.
[5] Indian Pharmacopoeia Commission. API Manufacturing in India: Market Review. 2022.

Suppliers and packagers for ANEXSIA 5/325

ANEXSIA 5/325

Suppliers for the Pharmaceutical Drug: ANEXSIA 5/325