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Suppliers and packagers for MOTOFEN
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MOTOFEN
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Legacy Pharma | MOTOFEN | 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 |
Suppliers for the Pharmaceutical Drug: MOTOFEN
Introduction
MOTOFEN is a pharmaceutical product primarily recognized under the brand name for its active ingredient, diclofenac, a non-steroidal anti-inflammatory drug (NSAID). Widely used for the management of pain, inflammation, and swelling associated with various musculoskeletal conditions, MOTOFEN plays a significant role within the therapeutic landscape. Given its high demand across global markets, identifying credible suppliers and understanding the supply chain dynamics for MOTOFEN is crucial for pharmaceutical companies, distributors, and healthcare providers seeking to ensure product availability, quality, and compliance.
Overview of MOTOFEN and Its Market Significance
MOTOFEN’s active compound, diclofenac, has been a staple in pain management for decades. The drug’s widespread use in oral, topical, and injectable forms has amplified the need for a consistent and reliable supply chain. Market reports indicate that the global NSAID market, including diclofenac-based products, is projected to reach USD 7.9 billion by 2027, reflecting sustained demand [1].
Manufacturers and suppliers serve as the backbone of this supply chain, ensuring availability from chemical synthesis to finished pharmaceutical formulations. The prominence of MOTOFEN in various therapeutic categories necessitates a detailed understanding of its primary sources and regional suppliers.
Key Components of the Supply Chain for MOTOFEN
The supply chain for MOTOFEN involves multiple levels:
- Active Pharmaceutical Ingredient (API) Suppliers
- Formulation and Finished Product Manufacturers
- Distribution Channels
- Regulatory and Quality Assurance Bodies
Focusing on API suppliers is vital, as they directly influence the quality, cost, and availability of MOTOFEN.
Major API Suppliers for Diclofenac (Active Ingredient in MOTOFEN)
Leading Global API Manufacturers
-
Hikma Pharmaceuticals
Hikma supplies pharmaceutical-grade diclofenac API. Their manufacturing facilities in Jordan and other regions adhere to cGMP standards, ensuring high-quality API production [2]. -
Aurobindo Pharma
Aurobindo, based in India, is a significant player in API manufacturing, including diclofenac. Their API factories are certified by global regulatory agencies, facilitating export to major markets [3]. -
Intas Pharmaceuticals
An Indian-based company, Intas manufactures diclofenac API with a focus on cost efficiency and compliance with international standards [4]. -
Laboratorios PiSA
A Mexican pharmaceutical company producing APIs for local and international markets, with certifications from EMA and other authorities [5]. -
Jubilant Life Sciences
Another Indian API manufacturer, Jubilant specializes in NSAID APIs including diclofenac, with comprehensive regulatory approval portfolios [6].
Regional Suppliers and Market Dynamics
Asia-Pacific
India and China dominate the API manufacturing landscape for diclofenac, owing to their cost-effective production capabilities. Indian firms such as Sun Pharma, Aurobindo, and Jubilant are prominent, with substantial export footprints. Chinese pharmaceutical API producers also supply to both regional and international markets, though supply chain stability varies amid geopolitical considerations.
Europe and North America
While some European and North American firms manufacture APIs domestically, many rely on imports from Indian and Chinese suppliers. European manufacturers like Sandoz and Hikma maintain strategic stockpiles, emphasizing quality compliance.
Latin America
Manufacturers such as Laboratorios PiSA and Eurofarma supply APIs primarily for regional markets but increasingly target exports, leveraging their quality certifications and competitive pricing.
Regulatory and Quality Considerations
Suppliers for MOTOFEN's API must comply with stringent global standards, including US FDA cGMP, EMA Good Manufacturing Practices, and other regional regulations. This compliance ensures that final pharmaceutical products meet safety and efficacy criteria.
Due diligence often involves verifying certificates of analysis (CoA), batch production records, and adherence to environmental and safety standards. Suppliers with registered facilities and proven regulatory track records are preferred, especially for regulated markets.
Major Finished Product Manufacturers of MOTOFEN
While MOTOFEN may be a branded formulation by specific pharmaceutical firms, generic manufacturers also produce diclofenac-based products. Leading companies include:
- Novartis (brand: Voltaren)
- Mylan
- Teva Pharmaceuticals
- Sandoz
- Sun Pharmaceutical Industries
These manufacturers often source APIs from established suppliers outlined above.
Supply Chain Challenges and Opportunities
Challenges:
- Variability in API quality and regulatory compliance
- Geopolitical risks affecting supply continuity
- Regulatory barriers imposing additional testing and documentation requirements
- Price fluctuations driven by raw material costs
Opportunities:
- Strategic partnerships with GMP-certified API producers
- Diversification of suppliers to mitigate risks
- Development of locally sourced APIs in emerging markets
- Investment in manufacturing capacity expansion
Future Outlook
The market for diclofenac API and MOTOFEN formulations is expected to remain robust, driven by the persistent demand for NSAIDs. Innovations in manufacturing processes, such as continuous manufacturing and greener synthesis methods, are poised to enhance supply reliability and sustainability.
Additionally, growing regulatory focus on quality assurance will necessitate closer collaborations with verified and compliant suppliers. As biosimilars and alternative NSAID therapies evolve, traditional API suppliers will need to adapt to maintain their market position.
Key Takeaways
- Global and regional API suppliers such as Aurobindo, Jubilant, Hikma, and Laboratorios PiSA are pivotal for MOTOFEN’s supply chain.
- Indian and Chinese manufacturers dominate diclofenac API production, offering cost advantages but necessitating rigorous quality verification.
- Compliance with international regulatory standards (cGMP, FDA, EMA) is essential for API suppliers to access premium markets.
- The supply chain faces challenges, including geopolitical risks and regulatory hurdles, but offers opportunities through diversification and technological advancements.
- Building strategic partnerships with verified API producers can ensure consistent, high-quality MOTOFEN supply.
FAQs
1. Who are the leading global suppliers of diclofenac API?
Major suppliers include Aurobindo Pharma, Jubilant Life Sciences, Hikma Pharmaceuticals, and Laboratorios PiSA, all adhering to global quality standards.
2. What should companies consider when sourcing API for MOTOFEN?
Regulatory compliance, quality certifications, production capacity, lead times, and the supplier’s track record are critical considerations.
3. Are Indian API manufacturers suitable for regulated markets?
Yes. Many Indian API producers possess certifications from agencies such as the US FDA and EMA, facilitating entry into stringent markets.
4. How do geopolitical factors impact API supply for MOTOFEN?
Trade disputes, regional conflicts, and export restrictions can disrupt supply chains, emphasizing the need for diversification.
5. What future trends will influence the MOTOFEN supply chain?
Technological innovations in manufacturing, increased regulatory oversight, and market diversification strategies will shape supply stability and quality.
References
[1] Market Research Future. "NSAID Market Outlook 2027."
[2] Hikma Pharmaceuticals. API manufacturing overview.
[3] Aurobindo Pharma. API registration and compliance report.
[4] Intas Pharmaceuticals. Annual manufacturing quality summary.
[5] Laboratorios PiSA. Regulatory approvals and certifications.
[6] Jubilant Life Sciences. API production and regulatory compliance.
By understanding the landscape of MOTOFEN’s suppliers, stakeholders can optimize sourcing strategies, mitigate risks, and ensure consistent access to this critical therapeutic.
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