Suppliers and packagers for MOTRIN IB

MOTRIN IB

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Kenvue Brands	MOTRIN IB	ibuprofen	TABLET;ORAL	019012	NDA	Navajo Manufacturing Company Inc.	67751-120-01	1 POUCH in 1 CARTON (67751-120-01) / 2 TABLET, FILM COATED in 1 POUCH	2016-09-22
Kenvue Brands	MOTRIN IB	ibuprofen	TABLET;ORAL	019012	NDA	Navajo Manufacturing Company Inc.	67751-120-02	2 POUCH in 1 CARTON (67751-120-02) / 2 TABLET, FILM COATED in 1 POUCH	2016-09-22

Suppliers for the Pharmaceutical Drug: MOTRIN IB

Last updated: August 3, 2025

Introduction

MOTRIN IB, a widely used over-the-counter analgesic and antipyretic, primarily contains ibuprofen as its active ingredient. Known for its efficacy in reducing fever, alleviating mild to moderate pain, and diminishing inflammation, MOTRIN IB remains a staple in pharmacy shelves globally. The supply chain for MOTRIN IB involves a complex network encompassing raw material providers, active pharmaceutical ingredient (API) manufacturers, formulators, and distributors. Understanding these suppliers is essential for stakeholders including healthcare providers, investors, regulatory bodies, and competitors to ensure supply security, compliance, and strategic planning.

Active Pharmaceutical Ingredient (API) Suppliers for Ibuprofen

The core of MOTRIN IB's formulation is ibuprofen, which must be synthesized and supplied by reliable API manufacturers that meet stringent quality and regulatory standards.

Major API Manufacturers

1. BASF SE
   A global leader in pharmaceuticals and chemicals, BASF supplies high-purity ibuprofen APIs adhering to client specifications. The company invests extensively in process innovation and quality assurance, ensuring consistent product supply. BASF's manufacturing plants in Germany and the USA support robust distribution channels for pharmaceutical companies.

2. Novartis AG
   Novartis, through its generic division, supplies ibuprofen APIs to several OTC and prescription drug manufacturers. Its manufacturing sites ensure high-grade API production conforming to global standards such as GMP (Good Manufacturing Practice) and stringent validation processes.

3. Shandong Sinome Pharmaceutical Co., Ltd.
   A notable Chinese API manufacturer, Sinome supplies ibuprofen APIs to international markets, with compliance to CE and GMP standards. The company's affordability and volume capacity make it a key player, especially in emerging markets.

4. Hubei Tianjing Pharmaceutical Co., Ltd.
   Based in China, Tianjing specializes in the production of NSAIDs like ibuprofen, ensuring consistent quality and regulatory compliance for export to North America and Europe.

5. Hercules Inc. / Thermo Fisher Scientific (Historical/Quality supplier)
   Historically a key player in chemical synthesis, Hercules Inc. has contributed to ibuprofen supply chains, now integrated within Thermo Fisher Scientific's pharmaceutical raw material segment.

API Supply Chain Challenges

• Regulatory Variability: Suppliers in China and India face evolving regulations that impact API certification and export compliance.
• Quality Assurance: Especially for APIs used in OTC drugs like MOTRIN IB, rigorous validation of purity, stability, and batch consistency is mandatory.
• Supply Security: Political and economic factors influence API availability; diversified sourcing mitigates risks.

Formulation and Final Product Manufacturers

Beyond API suppliers, the companies responsible for formulating MOTRIN IB tablets or caplets include:

• Johnson & Johnson Consumer Inc.
  As the primary marketer of MOTRIN IB, Johnson & Johnson oversees manufacturing facilities that handle formulation, packaging, and distribution. The company partners with contract manufacturing organizations (CMOs) globally.

• Contract Manufacturers (CMOs)
  Many OTC drugs, including MOTRIN IB, are produced via CMOs that specialize in high-volume, GMP-compliant manufacturing.

  • Catalent Inc.
    Catalent supplies formulation, filling, and packaging services for OTC drugs, including MOTRIN IB. Its facilities are GMP-certified, and it supports rapid scaling to meet demand surges.

  • Famar Pharma
    An European-based CMO known for handling OTC formulations, Famar collaborates with Johnson & Johnson to produce MOTRIN IB in various markets.

  • Recipharm AB
    A Swedish CMO, Recipharm produces OTC formulations, leveraging advanced filling technology and quality systems.

Distribution and Logistics Suppliers

Ensuring MOTRIN IB reaches pharmacies and consumers requires a network of logistics providers:

• DHL Supply Chain
  Offers temperature-controlled warehousing and distribution for sensitive OTC medications across global markets.

• UPS Healthcare
  Specializes in healthcare logistics, ensuring safe, compliant, and efficient distribution.

• Local Distributors and Wholesalers
  Major pharmaceutical wholesalers, such as McKesson and Cardinal Health in North America, handle extensive distribution channels for MOTRIN IB to pharmacies, grocery stores, and online retailers.

Strategic Supplier Considerations

1. Quality Certifications
   Suppliers must maintain GMP compliance, GMP certification for active ingredient manufacturing, and adhere to ISO standards to ensure product quality and regulatory acceptance.

2. Supply Chain Resilience
   Diversification across geographic regions mitigates risks linked to geopolitical tensions, natural disasters, or pandemic disruptions, as evidenced during COVID-19 supply chain disruptions.

3. Regulatory Compatibility
   Supplier registration and approval within target markets (FDA, EMA, etc.) are essential for legal distribution of MOTRIN IB.

4. Pricing and Capacity
   Cost-effective API suppliers with scalable capacity influence the pricing and availability of MOTRIN IB, especially amid fluctuating raw material costs.

Regulatory and Market Impact on Supplier Choices

Regulatory authorities, notably the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and counterparts globally, mandate rigorous supplier certifications for OTC products. Supplier compliance influences the supply chain security of MOTRIN IB, guiding manufacturers toward established, audited partners.

Conclusion

The supply landscape for MOTRIN IB hinges prominently on high-quality API sources, reliable formulation partners, and strategic logistics providers. Leading global API manufacturers such as BASF and Novartis ensure steady ibuprofen supply, while contract manufacturers like Catalent and Famar execute formulation and packaging at scale. Distribution channels further facilitate market access, emphasizing the necessity for diversified, compliant, and resilient supply chains to sustain the product’s global footprint.

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Key Takeaways

• Diverse API Suppliers: Multiple global sources, notably BASF and Novartis, underpin the ibuprofen API supply chain, reducing dependency risks.
• Quality and Compliance Priority: Suppliers must meet GMP and international regulatory standards, directly impacting MOTRIN IB's market acceptance.
• Contract Manufacturers' Role: CMOs like Catalent deliver scalable, GMP-compliant formulation and packaging, ensuring product consistency.
• Global Logistics: Efficient distribution hinges on specialized logistics providers capable of managing OTC medication distribution at scale.
• Risk Management: Supply chain resilience depends on geographic diversification, regulatory compliance, and contingency planning.

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Frequently Asked Questions (FAQs)

1. Who are the primary API suppliers for ibuprofen used in MOTRIN IB?
   Major API providers include BASF SE, Novartis AG, Sinome Pharmaceutical (China), and Hubei Tianjing Pharmaceutical, all adhering to stringent pharmaceutical standards.

2. How does regulatory compliance influence the supply chain of MOTRIN IB?
   Suppliers must possess GMP certification and meet regulatory approvals (FDA, EMA) to ensure seamless market access and maintain product safety standards.

3. What role do contract manufacturing organizations play in MOTRIN IB production?
   CMOs handle formulation, filling, and packaging, providing scalability, quality assurance, and operational flexibility vital for meeting global demand.

4. Are there risks associated with relying on international suppliers for MOTRIN IB?
   Yes, geopolitical factors, import restrictions, or quality inconsistencies can pose risks, underscoring the importance of supplier diversification and robust quality systems.

5. What considerations should companies make regarding logistics for OTC drugs like MOTRIN IB?
   Ensuring temperature-controlled logistics, compliance with pharmaceutical transport regulations, and establishing reliable global distribution networks are critical.

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References

1. [1] "Ibuprofen API Suppliers." PharmaSources, 2022.
2. [2] "Global Supply Chain Strategies for OTC Drugs." McKinsey & Company, 2021.
3. [3] "Regulatory Standards for API Manufacturing." U.S. FDA, 2023.
4. [4] "Manufacturing and Distribution of OTC Medications." Johnson & Johnson Annual Report, 2022.
5. [5] "Impact of Global Logistics on Pharmaceutical Supply." DHL Healthcare Insights, 2022.