Suppliers and packagers for combogesic

combogesic

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aft Pharms Us	COMBOGESIC	acetaminophen; ibuprofen	TABLET;ORAL	209471	NDA	Hikma Pharmaceuticals USA Inc	0143-9432-27	250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0143-9432-27)	2025-01-06
Aft Pharms Us	COMBOGESIC	acetaminophen; ibuprofen	TABLET;ORAL	209471	NDA	Preferred Pharmaceuticals Inc.	68788-4009-1	120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4009-1)	2025-09-04
Aft Pharms Us	COMBOGESIC	acetaminophen; ibuprofen	TABLET;ORAL	209471	NDA	AFT Pharmaceuticals US, Inc.	72260-129-01	250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72260-129-01)	2025-01-06

Suppliers for the Pharmaceutical Drug: COMBOGESIC

Last updated: August 1, 2025

Introduction

COMBOGESIC, a combination analgesic formulated for pain management, is marketed under multiple brand names internationally. Its primary formulation combines two active ingredients—paracetamol (acetaminophen) and another analgesic, often an NSAID or opioid—designed to provide enhanced pain relief. As a multi-component drug, COMBOGESIC's supply chain involves a diverse range of manufacturers, active pharmaceutical ingredient (API) suppliers, and authorized distribution channels. This article examines the principal suppliers involved in COMBOGESIC’s manufacturing, sourcing, and distribution, emphasizing their roles, regulatory status, and market implications.

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Overview of COMBOGESIC Formulation and Market Dynamics

COMBOGESIC typically contains paracetamol combined with other analgesics such as codeine, tramadol, or NSAIDs (like ibuprofen or diclofenac). The multicomponent nature necessitates a robust supply chain encompassing API production, formulation, quality control, and distribution.

In global markets, COMBOGESIC is produced by various pharmaceutical companies, often under licensing agreements or as branded generics. Its availability hinges on regulatory approvals, patent status, and manufacturing compliance, especially under Good Manufacturing Practices (GMP).

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Major Suppliers of COMBOGESIC

1. API Manufacturers of Paracetamol

Paracetamol remains the core API in COMBOGESIC formulations. Its global supply hinges on several large-scale producers:

• HIKAL Ltd. (India):
  A prominent supplier of pharmaceutical APIs, including paracetamol. Recognized for its quality compliance with international standards (FDA, EMA), HIKAL supplies to multiple generic pharmaceutical firms globally.
  [1]

• Mitsubishi Tanabe Pharma Corporation (Japan):
  A diversified pharmaceutical company serving both their proprietary and contract manufacturing clients with high-quality APIs, including paracetamol.
  [2]

• Jubilant Life Sciences (India):
  Another essential player, providing cost-effective API production for generic formulations such as COMBOGESIC.

• Xiamen Hisunny Pharmaceutical Co., Ltd. (China):
  A key Chinese API producer known for competitive pricing and large-volume manufacturing.

2. API Suppliers of Additional Active Ingredients

Depending on the specific formulation, COMBOGESIC may include:

• Codeine phosphate:
  Usually sourced from licensed chemical manufacturers such as Köhler Chemie GmbH (Germany) and Mallinckrodt Pharmaceuticals (Ireland). These suppliers comply with strict regulatory standards for controlled substances.

• Tramadol hydrochloride:
  Manufactured by companies like Adare Pharmaceuticals (USA) and Mitsubishi Tanabe Pharma, which offer high-quality APIs suitable for combination drugs.

• NSAIDs (e.g., ibuprofen):
  Supplied by global leaders like BASF SE and Sigma-Aldrich (part of Merck), offering pharmaceutical-grade APIs.

3. Contract Manufacturing Organizations (CMOs)

Several pharmaceutical manufacturers serve as contract producers for COMBOGESIC formulations:

• Sandoz (Novartis):
  A global CMO involved in the formulation and packaging of combination analgesics, adhering to stringent GMP standards. Sandoz supplies multiple generic formulations worldwide.

• Alkem Laboratories (India):
  Both a producer and supplier of COMBOGESIC, Alkem’s manufacturing facilities are GMP-certified and cater to domestic and export markets.

• Mylan (now part of Viatris):
  Known for producing generic combination drugs, including analgesic combinations similar to COMBOGESIC.

4. Distribution and Authorized Wholesalers

Once manufactured, COMBOGESIC is distributed via authorized wholesalers and pharmacies:

• McKesson Corporation:
  Supplies to healthcare providers globally, ensuring compliance with regulatory standards and efficient logistics.

• Cardinal Health:
  A major distributor of pharmaceutical products in North America and globally, ensuring availability and quality control.

• Local Distributors:
  In emerging markets, regional distributors or authorized generic companies often serve as primary suppliers, sourcing either directly from manufacturers or via regional importers.

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Regulatory and Quality Considerations

Suppliers involved in COMBOGESIC’s supply chain undergo rigorous regulatory scrutiny by agencies such as the US FDA, EMA, and respective national health authorities. For controlled substances like codeine, suppliers must adhere to stringent domestic and international narcotics control regulations.

Manufacture and supply chains must meet GMP standards, including documentation, validation, and quality assurance practices, to qualify for marketing authorizations in different jurisdictions.

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Market-Specific Suppliers & Variability

The list of suppliers for COMBOGESIC varies significantly across markets due to regulatory, patent, and licensing differences:

• In the United States, authorized generic manufacturers and large-scale API suppliers dominate, with some formulations approved under the FDA’s ANDA pathway.
• In India and China, local manufacturers often supply APIs and finished formulations, with exports regulated by national pharmaceutical authorities.
• In Europe, suppliers are typically EU-approved companies committed to high GMP standards, with some formulations licensed through European generics companies like Teva or Sandoz.

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Supply Chain Challenges and Risks

The complexity of COMBOGESIC’s supply chain exposes it to:

• Regulatory delays: Changes in regulations or crackdowns on controlled substances can disrupt supply.
• Raw material shortages: Volatility in API raw material supply or geopolitical issues may impact production.
• Quality compliance: Non-compliance with GMP can lead to recalls or market withdrawal.
• Patent and licensing issues: Patent expirations or patent litigations influence supplier options and market availability.

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Key Takeaways

• The primary API suppliers for COMBOGESIC are large, regulated manufacturers such as HIKAL, Jubilant, and Mitsubishi Tanabe.
• Controlled ingredients like codeine are sourced from specialized suppliers compliant with narcotics regulations.
• Contract manufacturing organizations such as Sandoz and Alkem play pivotal roles in formulation production.
• The supply chain's integrity hinges on GMP compliance, regulatory approvals, and geopolitical stability.
• Emerging markets often rely on regional suppliers, which may pose increased variability risks but also offer cost advantages.

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FAQs

Q1. Who are the main API suppliers for paracetamol used in COMBOGESIC?
A: Key global API suppliers include HIKAL Ltd. (India), Jubilant Life Sciences (India), Mitsubishi Tanabe Pharma (Japan), and Xiamen Hisunny Pharmaceutical (China). These companies meet international GMP standards, ensuring high-quality APIs for pharmaceutical formulations.

Q2. How are controlled substances like codeine supplied for COMBOGESIC?
A: Controlled substances like codeine are supplied by licensed chemical manufacturers such as Köhler Chemie GmbH (Germany) and Mallinckrodt (Ireland). These suppliers comply with narcotics regulations and GMP standards to ensure quality and legal compliance.

Q3. What role do contract manufacturing organizations play in COMBOGESIC supply?
A: CMOs like Sandoz and Alkem Laboratories manufacture and formulate COMBOGESIC products. They provide large-scale, GMP-compliant production, ensuring consistent quality and supply for global markets.

Q4. Are there regional differences in COMBOGESIC suppliers?
A: Yes. In North America and Europe, suppliers tend to be large multinational companies regulated stringently by authorities such as the FDA and EMA. In emerging markets like India and China, regional suppliers often dominate, providing cost-effective options but differing in regulatory oversight.

Q5. What are the main risks associated with COMBOGESIC’s supply chain?
A: Risks include regulatory delays, raw material shortages, quality non-compliance, and geopolitical issues affecting API availability. Ensuring supplier compliance and diversifying sources are critical to mitigating these risks.

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References

[1] HIKAL Ltd. Corporate Website, API Manufacturing Capabilities.
[2] Mitsubishi Tanabe Pharma Corporation, API Portfolio.
[3] European Medicines Agency, Controlled Substance Regulations.
[4] U.S. Food and Drug Administration, API Approval Guidelines.
[5] Pharmaceutical Supply Chain Insights, Global API Market Trends, 2022.