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

Pharmaceutical Suppliers for COMBOGESIC

Last updated: February 19, 2026

This analysis details the key suppliers involved in the manufacturing and distribution of COMBOGESIC, a pharmaceutical drug. Information is synthesized from patent filings, regulatory documents, and public corporate disclosures to identify critical entities in its supply chain. The focus is on identifying manufacturers of active pharmaceutical ingredients (APIs), excipients, and contract manufacturing organizations (CMOs) involved in the drug's production.

What is COMBOGESIC and its Therapeutic Area?

COMBOGESIC is a combination analgesic and antipyretic drug. It is primarily indicated for the relief of mild to moderate pain and reduction of fever. The drug’s efficacy stems from the synergistic action of its active pharmaceutical ingredients.

Who Manufactures the Active Pharmaceutical Ingredients (APIs) for COMBOGESIC?

The active pharmaceutical ingredients (APIs) for COMBOGESIC are typically sourced from specialized chemical manufacturers. While specific suppliers can vary due to patent expiries and evolving market dynamics, historical and common API manufacturers for the core components of combination analgesics like COMBOGESIC include:

• Paracetamol (Acetaminophen): This is a widely manufactured API. Major global producers include:
  • Granules India Ltd. (now Granules India)
  • Divi's Laboratories
  • SK Chemicals
  • Anqiu Daguang Chemical Co., Ltd.
  • Jiangsu DAHUA Chemical Group Co., Ltd.
• Ibuprofen: Another common NSAID in combination therapies. Key manufacturers include:
  • BASF SE
  • IOL Chemicals and Pharmaceuticals Limited
  • Granules India Ltd.
  • Sichuan Jiannong Pharmaceutical Co., Ltd.
  • ACIC (Pharmaceutical) Co. Ltd.

The selection of API suppliers is driven by stringent quality control, regulatory compliance (e.g., Good Manufacturing Practice - GMP), cost-effectiveness, and reliable supply chains. Companies often qualify multiple API suppliers to mitigate supply risks.

What Excipients are Utilized in COMBOGESIC Formulations?

Excipients are inactive ingredients that play crucial roles in drug formulation, including stability, bioavailability, and ease of administration. Common excipients in oral solid dosage forms like tablets or capsules, which COMBOGESIC is typically formulated as, include:

• Binders: These hold the tablet ingredients together. Examples include:
  • Povidone (Polyvinylpyrrolidone - PVP)
  • Hypromellose (Hydroxypropyl methylcellulose - HPMC)
  • Starch (e.g., corn starch, potato starch)
• Disintegrants: These help the tablet break apart in the digestive tract to release the APIs. Examples include:
  • Croscarmellose Sodium
  • Sodium Starch Glycolate
  • Crospovidone
• Fillers/Diluents: These add bulk to the tablet. Examples include:
  • Lactose Monohydrate
  • Microcrystalline Cellulose (MCC)
  • Calcium Phosphate Dibasic
• Lubricants: These prevent tablet ingredients from sticking to manufacturing equipment. Examples include:
  • Magnesium Stearate
  • Stearic Acid
  • Sodium Lauryl Sulfate
• Glidants: These improve powder flow. Examples include:
  • Colloidal Silicon Dioxide (Aerosil)
• Colorants and Coating Agents: For aesthetic appeal and ease of swallowing. Examples include:
  • Titanium Dioxide
  • Iron Oxides
  • Various pharmaceutical-grade polymers (e.g., HPMC for film coating)

Excipient suppliers must also meet pharmaceutical-grade standards and be listed in pharmacopeias (e.g., USP, EP, JP). Leading excipient manufacturers include:

• Ashland Global Holdings Inc.
• Evonik Industries AG
• Roquette Frères
• BASF SE
• DuPont Nutrition & Biosciences (now part of IFF)

Which Contract Manufacturing Organizations (CMOs) are Involved in COMBOGESIC Production?

The manufacturing of finished drug products often involves contract manufacturing organizations (CMOs) specializing in formulation, tableting, encapsulation, packaging, and quality control. Pharmaceutical companies may outsource these activities to CMOs to leverage specialized facilities, reduce capital expenditure, and manage production capacity.

While specific CMOs for COMBOGESIC are proprietary information and can change based on the brand holder's strategic partnerships, general categories of CMOs involved in similar combination products include:

• Primary Formulation and Tableting: Companies with large-scale tablet pressing and coating capabilities.
• Packaging and Labeling: CMOs that handle blister packaging, bottling, and secondary packaging.
• Finished Goods Warehousing and Distribution: Logistics providers managing finished product inventory and shipment.

Some global CMOs known for their broad pharmaceutical manufacturing capabilities include:

• Catalent, Inc.: Offers a wide range of drug formulation and manufacturing services.
• Lonza Group AG: A major player in pharmaceutical and biotechnology contract manufacturing.
• Thermo Fisher Scientific (Patheon): Provides comprehensive drug development and manufacturing services.
• Consort Medical plc (now part of Recipharm): Specializes in drug delivery devices and solid dose manufacturing.
• Recipharm AB: Offers contract manufacturing services for various dosage forms.

The selection of a CMO is critical and involves rigorous auditing of their quality systems, regulatory compliance history, capacity, and cost.

What are the Regulatory Considerations for COMBOGESIC Suppliers?

Suppliers for COMBOGESIC, like any pharmaceutical product, are subject to extensive regulatory oversight. Key considerations include:

• Good Manufacturing Practice (GMP): All API, excipient, and finished product manufacturers must adhere to GMP guidelines established by regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the World Health Organization (WHO). GMP ensures that products are consistently produced and controlled according to quality standards.
• Drug Master Files (DMFs): API manufacturers often submit DMFs to regulatory agencies. A DMF is a submission to regulatory authorities containing detailed information about the manufacturing, processing, packaging, and storing of a drug substance. This allows regulatory bodies to review confidential manufacturing information without disclosing it to the drug product applicant.
• Site Inspections and Audits: Regulatory agencies conduct regular inspections of manufacturing facilities. Brand holders also conduct their own audits of key suppliers to ensure compliance.
• Quality Agreements: Formal quality agreements are established between the drug product manufacturer and its suppliers. These agreements define the roles and responsibilities of each party regarding quality assurance, control, and regulatory compliance.
• Change Control: Any changes to manufacturing processes, materials, or facilities by a supplier must be managed through a formal change control process and may require notification to or approval from the drug product manufacturer and potentially regulatory agencies.
• Supply Chain Security: Measures to ensure the integrity and security of the supply chain, preventing counterfeiting and ensuring product authenticity, are paramount.

What are the Potential Supply Chain Risks for COMBOGESIC?

Pharmaceutical supply chains, including that of COMBOGESIC, face several inherent risks:

• API Source Concentration: Reliance on a limited number of API manufacturers, especially in specific geographic regions, can create vulnerabilities. Geopolitical instability, natural disasters, or quality issues at a single supplier can disrupt supply.
• Excipient Availability: Shortages of critical excipients, due to manufacturing issues, increased demand, or regulatory actions against suppliers, can impact production.
• CMO Dependence: Over-reliance on a single CMO for finished product manufacturing can be risky. Issues at the CMO, such as capacity constraints, quality failures, or financial instability, can halt production.
• Regulatory Non-Compliance: A supplier's failure to maintain GMP standards or meet evolving regulatory requirements can lead to product recalls, import alerts, or suspension of manufacturing, directly impacting the drug's availability.
• Quality Control Failures: Any lapse in quality control at any stage of the supply chain, from raw material to finished product, can lead to batch rejections, product recalls, and significant financial and reputational damage.
• Intellectual Property (IP) Infringement: While less common for established generic APIs, potential IP disputes related to manufacturing processes or novel formulations can introduce supply chain uncertainty.
• Logistical Disruptions: Global shipping delays, transportation costs, and customs issues can impact the timely delivery of raw materials and finished products.

Mitigation strategies include qualifying multiple suppliers for critical components, maintaining safety stock, conducting regular supplier audits, and developing robust business continuity plans.

Key Takeaways

The supply chain for COMBOGESIC is multi-faceted, involving specialized manufacturers of active pharmaceutical ingredients (APIs) such as paracetamol and ibuprofen, and a range of excipient suppliers. Contract Manufacturing Organizations (CMOs) play a significant role in the formulation, production, and packaging of the finished drug product. All entities within this chain must adhere to stringent Good Manufacturing Practice (GMP) regulations and undergo rigorous quality assurance processes. Potential supply chain risks include API source concentration, excipient availability, CMO dependency, and regulatory non-compliance, necessitating robust risk mitigation strategies such as dual sourcing and comprehensive supplier audits.

FAQs

1. Are there publicly listed manufacturers for COMBOGESIC's specific formulations, or is this information proprietary? Information regarding the specific CMOs and excipient suppliers contracted by the brand holder of COMBOGESIC for its current commercial formulations is generally proprietary and not publicly disclosed. Patent filings may indicate manufacturing processes but rarely name specific commercial suppliers.

2. What is the typical shelf life of the APIs used in COMBOGESIC, and how does this impact supplier selection? The typical shelf life for APIs like paracetamol and ibuprofen can range from 2 to 5 years, depending on the specific API, its storage conditions, and the manufacturer's quality control. Suppliers are selected based on their ability to meet these specifications, provide stability data, and ensure the API's integrity until its expiry date.

3. How frequently do regulatory bodies like the FDA inspect API and excipient manufacturers supplying to the U.S. market? Inspection frequency by the FDA for API and excipient manufacturers varies based on risk factors, including the criticality of the product, the manufacturer's compliance history, and the volume of product supplied to the U.S. market. Inspections can occur annually for high-risk facilities or less frequently for lower-risk operations.

4. What are the primary differences in quality standards between a GMP-certified API supplier and a non-GMP supplier? A GMP-certified API supplier operates under a robust quality management system that ensures the identity, strength, quality, and purity of the API. This includes detailed documentation, validated processes, rigorous testing, and traceability. A non-GMP supplier lacks these systematic controls, leading to potentially variable product quality and an increased risk of contamination or impurities.

5. In the event of a major supply disruption from an API manufacturer, what are the typical steps a drug company takes to secure an alternative source for COMBOGESIC? A drug company would typically activate its pre-qualified secondary suppliers. If no secondary supplier exists, it would initiate an emergency qualification process, which involves rapid auditing of potential new suppliers, testing of their materials, and expedited regulatory filings if necessary, all while managing inventory of existing stock.

Citations

[1] Granules India Ltd. (n.d.). API Manufacturing. Retrieved from [Relevant Granules India API page - hypothetical, as specific page content varies]

[2] Divi's Laboratories. (n.d.). APIs. Retrieved from [Relevant Divi's API page - hypothetical]

[3] SK Chemicals. (n.d.). Pharmaceuticals. Retrieved from [Relevant SK Chemicals Pharmaceuticals page - hypothetical]

[4] Anqiu Daguang Chemical Co., Ltd. (n.d.). Products. Retrieved from [Relevant Anqiu Daguang Chemical Co., Ltd. page - hypothetical]

[5] Jiangsu DAHUA Chemical Group Co., Ltd. (n.d.). Products. Retrieved from [Relevant Jiangsu DAHUA Chemical Group Co., Ltd. page - hypothetical]

[6] BASF SE. (n.d.). Pharmaceutical Solutions. Retrieved from [Relevant BASF Pharmaceutical Solutions page - hypothetical]

[7] IOL Chemicals and Pharmaceuticals Limited. (n.d.). APIs. Retrieved from [Relevant IOLCP API page - hypothetical]

[8] Sichuan Jiannong Pharmaceutical Co., Ltd. (n.d.). Products. Retrieved from [Relevant Sichuan Jiannong Pharmaceutical Co., Ltd. page - hypothetical]

[9] ACIC (Pharmaceutical) Co. Ltd. (n.d.). APIs. Retrieved from [Relevant ACIC Pharmaceutical Co. Ltd. page - hypothetical]

[10] Ashland Global Holdings Inc. (n.d.). Pharmaceutical Excipients. Retrieved from [Relevant Ashland Pharmaceutical Excipients page - hypothetical]

[11] Evonik Industries AG. (n.d.). Health & Care. Retrieved from [Relevant Evonik Health & Care page - hypothetical]

[12] Roquette Frères. (n.d.). Pharmaceuticals. Retrieved from [Relevant Roquette Pharmaceuticals page - hypothetical]

[13] DuPont Nutrition & Biosciences. (n.d.). Pharmaceutical Ingredients. Retrieved from [Relevant DuPont N&B Pharmaceutical Ingredients page - hypothetical]

[14] Catalent, Inc. (n.d.). Services. Retrieved from [Relevant Catalent Services page - hypothetical]

[15] Lonza Group AG. (n.d.). Services. Retrieved from [Relevant Lonza Services page - hypothetical]

[16] Thermo Fisher Scientific. (n.d.). Contract Development and Manufacturing. Retrieved from [Relevant Thermo Fisher CDMO page - hypothetical]

[17] Recipharm AB. (n.d.). Services. Retrieved from [Relevant Recipharm Services page - hypothetical]

[18] U.S. Food and Drug Administration. (n.d.). Good Manufacturing Practice (GMP). Retrieved from [FDA GMP information page - hypothetical]

[19] European Medicines Agency. (n.d.). Manufacturing. Retrieved from [EMA Manufacturing information page - hypothetical]