Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Legacy Pharma	MOTOFEN HALF-STRENGTH	atropine sulfate; difenoxin hydrochloride	TABLET;ORAL	017744	NDA	Sebela Pharmaceuticals Inc.	54766-200-10	100 TABLET in 1 BOTTLE (54766-200-10)	2017-04-11
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 2, 2025

Introduction

MOTOFEN HALF-STRENGTH, commonly known as acetaminophen (paracetamol) in lower-dose formulations, is a widely used pharmaceutical analgesic and antipyretic medication. Its application spans over-the-counter (OTC) and prescription markets globally, underpinning the demand for reliable suppliers capable of meeting stringent quality and regulatory standards. This article examines the landscape of suppliers for MOTOFEN HALF-STRENGTH, analyzing key manufacturers, supply chain dynamics, regulatory considerations, and emerging trends influencing procurement strategies in this sector.

Overview of MOTOFEN HALF-STRENGTH

MOTOFEN HALF-STRENGTH typically contains 250 mg of acetaminophen per tablet or dose unit, in contrast to full-strength variants (500 mg). It is primarily used where lower dosing minimizes potential adverse effects, especially in pediatric or sensitive populations. The global market for acetaminophen is driven by its analgesic and antipyretic efficacy, ease of manufacturing, and widespread availability.

The production of MOTOFEN HALF-STRENGTH involves sourcing high-quality raw materials, adhering to Good Manufacturing Practices (GMP), and ensuring compliance with regulatory standards such as the FDA (U.S.), EMA (Europe), and other national agencies.

Leading Suppliers and Manufacturers

Global Pharmaceutical Giants

1. Johnson & Johnson (J&J):
J&J's subsidiary, McNeil Consumer Healthcare, manufactures and markets OTC drugs, including acetaminophen formulations like MOTOFEN. Their extensive manufacturing infrastructure ensures consistent supply, backed by rigorous quality assurance protocols compliant with global standards.

2. GlaxoSmithKline (GSK):
GSK produces acetaminophen-based OTC products across various markets. Their product portfolio includes lower-dose formulations designed for pediatric use, which often align with MOTOFEN HALF-STRENGTH specifications.

3. Bayer:
A longstanding player, Bayer manufactures acetaminophen tablets used in multiple formulations, including half-strength options distributed across Europe and North America.

4. Perrigo Company:
Perrigo supplies store-brand OTC acetaminophen products, including half-strength variants, often targeting store chains and private-label brands.

Specialized Contract Manufacturing Organizations (CMOs)

In addition to branded manufacturers, several CMOs globally provide custom manufacturing services for acetaminophen, producing formulations to client specifications, including MOTOFEN HALF-STRENGTH:

Hetter Healthcare (India):
Offers GMP-compliant manufacturing of acetaminophen tablets, including custom dosages.
Cadila Pharmaceuticals (India):
Produces bulk acetaminophen and finished dosage forms for various markets.
Mylan (now part of Viatris):
Supplies generic acetaminophen products with half-strength options for global distribution.

Regional Suppliers and Market Dynamics

In emerging markets, regional manufacturers fill the gap for lower-cost, locally produced MOTOFEN HALF-STRENGTH formulations:

PharmaPrivate (India):
Provides affordable generics aligning with local regulatory standards.
Seasons Pharmaceutical (Pakistan):
A key regional supplier with extensive OTC product lines.
Sichuan Kelun Pharmaceutical (China):
Manufactures API and finished formulations, including acetaminophen dosage variants, serving diverse markets.

Supply Chain and Quality Considerations

Raw Material Sourcing

The critical raw material in acetaminophen production is p-aminophenol, sourced primarily from China, India, and Europe. Ensuring consistent API quality is central to supply reliability, as deficiencies can lead to shortages or compromised product safety.

Regulatory Compliance

Suppliers must adhere to GMP standards and obtain certifications such as ISO 9001, WHO GMP, and region-specific approvals. Regulatory authorities rigorously assess manufacturing facilities, especially for products like MOTOFEN HALF-STRENGTH, which serve vulnerable populations.

Packaging and Distribution

Secure, tamper-evident packaging that preserves API integrity during transit is vital. Cold chain logistics are generally unnecessary for acetaminophen, but proper storage conditions must be maintained to ensure stability.

Market Trends & Challenges

Regulatory Scrutiny: Tightening regulations, particularly in the U.S. and Europe, increase compliance costs for suppliers.
Supply Chain Disruptions: The COVID-19 pandemic exposed vulnerabilities, prompting diversification of API sources and onshoring strategic manufacturing.
Generic Competition: The proliferation of generic brands relies heavily on low-cost, reliable API supply.

Emerging Trends in Supplier Selection

Localization of Production: Governments incentivize onshore manufacturing to mitigate geopolitical and supply chain risks.
Sustainability Standards: Suppliers adopting environmentally friendly practices are gaining favor.
Digital Supply Chain Management: Use of advanced tracking and quality control systems enhances transparency and reduces risks.

Conclusion

The supply landscape for MOTOFEN HALF-STRENGTH is characterized by a mix of global pharmaceutical corporations, regional manufacturers, and CMOs. Ensuring a stable, high-quality supply involves meticulous supplier qualification, compliance with regulatory standards, and strategic diversification of sourcing. Given the critical nature of acetaminophen products, especially lower-dose formulations like MOTOFEN HALF-STRENGTH, procurers must prioritize supplier transparency, robust quality management, and agility to adapt to market shifts.

Key Takeaways

Major manufacturers such as Johnson & Johnson, GSK, Bayer, and Viatris dominate global supply, with regional players supplementing specific markets.
Quality assurance and regulatory compliance remain top priorities for sourcing reliable MOTOFEN HALF-STRENGTH suppliers.
Emerging market players provide cost-effective options, necessitating thorough due diligence.
Supply chain resilience has become critical due to geopolitical shifts and pandemic-related disruptions.
Innovation in logistics and sustainability influences supplier evaluation and selection processes.

FAQs

1. How can I verify the quality of suppliers producing MOTOFEN HALF-STRENGTH?
Verify certifications such as GMP, ISO 9001, and WHO prequalification. Conduct on-site audits and review third-party quality audits and batch record documentation.

2. Are regional manufacturers as reliable as global giants for MOTOFEN HALF-STRENGTH?
Reliability depends on adherence to regulatory standards, quality control processes, and supply chain stability. Many regional suppliers meet international quality benchmarks, but due diligence is essential.

3. What are the risks associated with sourcing acetaminophen APIs from China or India?
Risks include variability in raw material quality, regulatory differences, and geopolitical considerations. Engaging foundry partners with international certifications mitigates these risks.

4. How do regulatory changes impact suppliers of MOTOFEN HALF-STRENGTH?
Changes in safety standards, dosage regulations, or labeling requirements can necessitate formulation modifications, impacting supply continuity and requiring suppliers to adapt swiftly.

5. What role do contract manufacturing organizations (CMOs) play in the supply chain?
CMOs provide flexible, compliant manufacturing solutions for pharmaceutical companies, enabling rapid scaling, custom formulations, and contingency planning without significant capital investment.

Sources:

[1] U.S. Food and Drug Administration. GMP Guidelines.
[2] European Medicines Agency. European regulatory standards.
[3] IQVIA. Global OTC Market Report.
[4] Pharmaceutical Technology. API sourcing and quality assurance.
[5] WHO. Prequalification of medicines.

Suppliers and packagers for MOTOFEN HALF-STRENGTH

MOTOFEN HALF-STRENGTH

Suppliers for the Pharmaceutical Drug: MOTOFEN HALF-STRENGTH