Suppliers and packagers for OXYCET

OXYCET

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Specgx Llc	OXYCET	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	087463	ANDA	SpecGx LLC	0406-0512-01	100 TABLET in 1 BOTTLE (0406-0512-01)	1983-12-07
Specgx Llc	OXYCET	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	087463	ANDA	SpecGx LLC	0406-0512-05	500 TABLET in 1 BOTTLE (0406-0512-05)	1983-12-07
Specgx Llc	OXYCET	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	087463	ANDA	SpecGx LLC	0406-0512-23	1 TABLET in 1 BLISTER PACK (0406-0512-23)	1983-12-07
Specgx Llc	OXYCET	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	087463	ANDA	SpecGx LLC	0406-0512-62	100 TABLET in 1 BLISTER PACK (0406-0512-62)	1983-12-07
Specgx Llc	OXYCET	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	087463	ANDA	SpecGx LLC	0406-0512-91	5000 TABLET in 1 PAIL (0406-0512-91)	1983-12-07

Suppliers for the Pharmaceutical Drug: Oxycet

Last updated: August 1, 2025

Introduction

Oxycet, a pharmaceutical product primarily utilized for its analgesic and antipyretic properties, is categorized within the non-steroidal anti-inflammatory drugs (NSAIDs) or opioid analgesic classes depending on its formulation and intended use. The sourcing and supply chain integrity of oxycet are critical, especially given the stringent regulatory landscape, patent lounges, and the increasing demand for opioid and NSAID therapeutics globally. This analysis provides an in-depth overview of the key suppliers, manufacturing landscape, and supply chain considerations for oxycet.

Overview of Oxycet

Oxycet most often contains active ingredients such as oxycodone (for pain management) or acetaminophen (paracetamol) combined with other analgesics. Its widespread use in pain management, post-surgical analgesia, and chronic pain conditions has driven high quantities into global markets, necessitating a comprehensive understanding of its supplier ecosystem.

Major Manufacturers and Suppliers

1. Global Pharmaceutical Giants

The supply chain for oxycet primarily involves the world's largest pharmaceutical corporations, which possess the manufacturing capacity, regulatory approval, and global distribution networks required to produce and supply this medication at scale.

• McKesson Corporation: As one of the largest global distributors of pharmaceutical products, McKesson sources oxycet from licensed manufacturers and serves as a central distributor across North America and other regions.

• McNeil Consumer Healthcare (Johnson & Johnson): Produces OTC formulations of acetaminophen-based combination drugs, including certain oxycet formulations, with rigorous quality control and compliance standards.

• Teva Pharmaceutical Industries: A dominant generic manufacturer, Teva supplies oxycet formulations to numerous markets under strict manufacturing standards compliant with international Good Manufacturing Practices (GMP).

• Sandoz (Novartis): Offers generic oxycet products for various regulated markets, leveraging extensive manufacturing facilities and distribution channels.

• Pfizer: Produces and distributes opioid-based formulations of oxycet, particularly in regions where opioid analgesics are regulated under strict prescription controls.

2. Regional and Local Manufacturers

Regional players often fill local demand due to manufacturing licenses, regional regulatory approval, and strategic distribution networks.

• Sun Pharmaceutical Industries (India): A major regional supplier manufacturing generic oxycet formulations in compliance with local regulatory standards, exporting to diverse markets, especially in Asia, Africa, and parts of Europe.

• Cipla: Known for its diverse range of generic pharmaceuticals, Cipla supplies oxycet in various formulations to developing countries, often at lower price points.

• Aurobindo Pharma: Another key Indian manufacturer, Aurobindo offers oxycet formulations with a focus on affordability and compliance with regional pharmaceutical regulations.

• Mylan (now part of Viatris): Provides generic oxycet formulations in multiple territories, emphasizing regulatory compliance, supply security, and pricing.

3. Contract Manufacturing Organizations (CMOs)

For brands or smaller manufacturers unable to sustain their own manufacturing facilities, CMOs serve as crucial suppliers:

• Recipharm: Offers contract manufacturing of oxycet formulations, ensuring adherence to international standards.

• Thermo Fisher Scientific: Engages in the production of APIs (active pharmaceutical ingredients) and finished formulations, including opioid compounds.

• These CMOs often supply to the larger brand holders, ensuring scalability and regulatory compliance without heavy capital investment.

Supply Chain Considerations

Active Pharmaceutical Ingredient (API) Suppliers

The backbone of oxycet's supply chain is the API, which encompasses oxycodone and acetaminophen components.

• Chinese API producers dominate global oxycodone API supply chains, leveraging lower manufacturing costs. Key factories include Zhejiang Hisoar Pharmaceuticals and Zhejiang Pharma Co.

• Indian API suppliers like Sun Pharma and Aurobindo also produce oxycodone APIs at scale, supplying both domestic and international markets.

• Regulatory oversight of APIs from China and India varies, emphasizing the importance of stringent quality assurance and control measures for downstream suppliers and distributors.

Regulatory and Compliance Factors

• Drug Enforcement Agency (DEA) (U.S.): Regulates controlled substances, including oxycodone, adding layers of compliance for manufacturers and distributors.

• European Medicines Agency (EMA): Oversees approval and manufacturing standards within European markets for oxycet.

• World Health Organization (WHO): Provides guidelines for controlled substance production and distribution.

Manufacturers and suppliers must maintain GMP compliance, with regular inspections and certifications, which significantly influence sourcing options, especially in tightly regulated markets like the U.S., Europe, and Australia.

Emerging Trends and Challenges

Supply Chain Security

The illicit trafficking of opioid APIs, particularly from regions like China and India, continues to challenge law enforcement and regulatory agencies. As such, verified and compliant suppliers are highly sought after to mitigate black-market risks.

Patent and Regulatory Shifts

Patent expirations in various regions have increased the supply base, but new formulations or formulations with abuse-deterrent properties are also entering the market, influencing supplier strategies.

Manufacturing Capacity and Scalability

Demand fluctuations, especially during health crises like the COVID-19 pandemic, prompted manufacturers to expand capacity rapidly. Ensuring quality remains consistent amidst expansion is a critical supply chain challenge.

Conclusion

The landscape of oxycet suppliers is characterized by a blend of global pharmaceutical leaders, regional generic manufacturers, and specialized CMOs. Chinese and Indian API producers underpin the supply of active ingredients, but regulatory compliance and quality assurance are vital factors influencing supplier selection. Leading pharmaceutical companies leverage extensive manufacturing, distribution, and regulatory expertise to ensure a steady, compliant supply chain capable of meeting global demand.

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Key Takeaways

• Major global players, including McKesson, Johnson & Johnson, Teva, Sandoz, and Pfizer, dominate the oxycet supply chain, with regional players like Sun Pharma, Cipla, and Aurobindo serving local markets.

• API sourcing from Chinese and Indian manufacturers is central to global supply, but regulatory scrutiny necessitates rigorous QA processes.

• Regulatory compliance (GMP, DEA, EMA) is crucial for supplier credibility and market access, especially given the controlled substance status of oxycet.

• Contract manufacturing and regional producers offer flexibility and scalability but require diligent quality oversight.

• Supply chain resilience requires managing risks related to regulatory changes, illicit trafficking, and capacity constraints.

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FAQs

1. Who are the top manufacturers of oxycet?
Leading manufacturers include Teva, Johnson & Johnson (McNeil), Pfizer, Sandoz, and regional players like Sun Pharma and Cipla, especially for generic formulations.

2. Where do the active ingredients for oxycet primarily come from?
The API, particularly oxycodone, is predominantly sourced from Chinese and Indian manufacturers, with some production also occurring domestically in the countries where formulations are manufactured.

3. What regulatory bodies oversee oxycet supply chains?
In the U.S., the DEA regulates controlled substances. The EMA supervises European markets. Internationally, WHO provides guidelines. Good Manufacturing Practices (GMP) standards are enforced globally.

4. What are the supply chain risks associated with oxycet?
Risks include regulatory changes, illicit trafficking of APIs and formulations, capacity constraints, quality assurance failures, and geopolitical issues affecting trade.

5. How has the market for oxycet evolved recently?
Market dynamics are influenced by patent expirations, increased generic entries, regulatory shifts towards abuse-deterrent formulations, and heightened control measures which tighten supply and influence sourcing strategies.

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References

[1] U.S. Drug Enforcement Administration. "Controlled Substance Schedules."
[2] European Medicines Agency. "Guidelines on Good Manufacturing Practices."
[3] IMS Health. "Global Pharmaceutical Market Reports."
[4] OECD. "Trade in Active Pharmaceutical Ingredients."
[5] Industry Reports. "Global Supply Chain Analysis of Opioids and NSAIDs."