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Suppliers and packagers for daypro
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daypro
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Pfizer | DAYPRO | oxaprozin | TABLET;ORAL | 018841 | NDA | Pfizer Laboratories Div Pfizer Inc | 0025-1381-31 | 100 TABLET, FILM COATED in 1 BOTTLE (0025-1381-31) | 1992-10-29 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Daypro (Mefenamic Acid)
Introduction
Daypro is a prescription non-steroidal anti-inflammatory drug (NSAID) primarily used for the management of pain, inflammation, and fever associated with various conditions such as rheumatoid arthritis, osteoarthritis, and menstrual pain. Its active ingredient is mefenamic acid. The drug is marketed under various brand names and is available through numerous global suppliers and manufacturers. This article provides a comprehensive overview of the primary suppliers for Daypro, focusing on manufacturing companies, authorized distributors, and regional availability, essential for pharmaceutical businesses and healthcare providers aiming to secure reliable sources.
Overview of Mefenamic Acid and Daypro
Mefenamic acid, first introduced in the 1960s, belongs to the fenamic acid class of NSAIDs. It offers analgesic, antipyretic, and anti-inflammatory properties, making it suitable for mild to moderate pain. Daypro, as a branded formulation, combines chemical stability with rigorous quality standards, manufactured by established pharmaceutical companies compliant with international regulations such as the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency).
Major Manufacturers of Daypro and Mefenamic Acid
1. Solara Active Pharma Sciences Ltd.
Overview:
Solara is one of the prominent manufacturers of mefenamic acid globally, supplying active pharmaceutical ingredients (APIs) to pharmaceutical companies worldwide. The company maintains cGMP (current Good Manufacturing Practices) certifications and complies with international quality standards.
Supply:
They produce high-quality mefenamic acid API, which is subsequently formulated by brand-name and generic drug manufacturers into Daypro and related products.
Regional Focus:
Primarily serves markets in North America, Europe, and Asia, with a well-established export network.
2. Nanjing Zelangen Pharmaceutical Co., Ltd.
Overview:
Nanjing Zelangen Pharmaceutical is a Chinese pharmaceutical company specializing in the production of NSAID APIs, including mefenamic acid. The company supplies APIs globally and has received multiple international quality certifications.
Supply:
They produce both raw API and finished dosage forms, working with various international pharmaceutical firms to meet global demand.
Regional Focus:
Strong presence in Asia, with exports to Europe and North America.
3. MIRA Pharmaceuticals Ltd.
Overview:
Based in India, MIRA Pharmaceuticals focuses on manufacturing and supplying mefenamic acid API. Their products are recognized for compliance with Indian and international GMP standards.
Supply:
Their API is used in formulations for Daypro generics and other NSAID products.
Regional Focus:
Primarily serves the Indian subcontinent and exports to global markets, including Africa, Southeast Asia, and the Middle East.
4. Zhejiang Hisoar Pharmaceutical Co., Ltd.
Overview:
This Chinese firm supplies high-purity mefenamic acid. The company emphasizes advanced synthesis processes and rigorous quality control.
Supply:
Offers APIs suitable for pharmaceutical formulations and licensed generic versions of Daypro.
Regional Focus:
Exports mainly to Europe, North America, and Asia.
5. Solara Active Pharma Scienes Ltd. (Continued)
Additional Capacity:
In addition to API manufacturing, Solara actively licenses formulations and partners with brand-name manufacturers to ensure consistent supply chains. This integration enhances supply stability for Daypro across various regions.
Authorized Distributors and Regional Suppliers
In addition to direct API manufacturers, regional pharmaceutical distributors and authorized suppliers play a vital role in the supply chain of Daypro.
A. North American Distributors
-
McKesson Corporation:
Offers Daypro formulations through its extensive network, sourcing APIs from multiple manufacturers including Solara. -
McNeil Consumer Healthcare:
Supplies Daypro or generic versions via licensed distribution channels, ensuring quality compliance.
B. European Suppliers
-
STADA Arzneimittel AG:
A major distributor of NSAID generics, including mefenamic acid formulations, with supply chains aligned with European regulatory standards (EMA). -
Teva Pharmaceutical Industries:
Offers generic NSAIDs, including mefenamic acid, through regional wholesalers and pharmacies.
C. Asian Suppliers
-
Sun Pharmaceutical Industries Ltd.:
Provides both APIs and finished formulations including Daypro equivalents, primarily for the Indian subcontinent. -
Dr. Reddy’s Laboratories:
Supplies generic NSAID formulations with established regional distribution channels.
Regulatory and Quality Considerations
The procurement of Daypro suppliers must adhere to stringent quality controls. Manufacturers must demonstrate compliance with cGMP certifications, quality assurance protocols, and relevant international standards to ensure the safety and efficacy of their products. Suppliers like Solara, Nanjing Zelangen, and MIRA operate under these strict regulatory frameworks, making their products preferable for pharmaceutical companies seeking quality assurance.
Supply Chain Dynamics and Market Trends
The global demand for NSAIDs, including mefenamic acid, remains robust. Supply chain stability hinges on reliable API production and effective distribution channels. The recent trend toward increased outsourcing and regional manufacturing alliances enhances availability, especially in emerging markets. However, geopolitical factors, import-export regulations, and raw material availability can influence supply stability for Daypro.
Key Challenges in Supplier Selection
- Regulatory compliance: Ensuring suppliers meet regional and international standards.
- Quality consistency: Verifying product purity, potency, and stability.
- Supply reliability: Confirming capacity and contingency plans to prevent shortages.
- Pricing and contract terms: Negotiating favorable terms while maintaining quality standards.
- Traceability: Maintaining transparent documentation for batch origin and handling.
Conclusion
Securing a dependable supplier for Daypro necessitates navigating a complex landscape of manufacturers, regional distributors, and regulatory requirements. Leading API producers like Solara Active Pharma Sciences, Nanjing Zelangen, and MIRA Pharmaceuticals dominate the supply chain, offering high-quality mefenamic acid suitable for formulating Daypro. Regional distributors further facilitate access within specific markets, provided compliance with regulatory standards is maintained.
For pharmaceutical companies and healthcare providers, choosing suppliers with verified quality certifications, stable supply capacity, and compliant manufacturing processes ensures consistent patient outcomes and regulatory adherence.
Key Takeaways
- Leading API manufacturers: Solara Active Pharma Sciences, Nanjing Zelangen, and MIRA Pharmaceuticals are primary sources of mefenamic acid used in Daypro.
- Regional distribution channels: Major global distributors such as McKesson, Teva, and Sun Pharma ensure regional availability.
- Regulatory adherence: Supplier qualification should prioritize GMP compliance and international certifications.
- Supply chain resilience: Diversifying suppliers and maintaining robust validation processes mitigates shortage risks.
- Market dynamics: The growing global demand for NSAIDs underscores the importance of reliable, quality-focused suppliers.
FAQs
1. What are the primary regions supplying Daypro or mefenamic acid?
The primary regions include North America, Europe, and Asia, with India and China being notable manufacturing hubs, supported by established distributors worldwide.
2. How do I verify the quality of a mefenamic acid supplier?
Verify GMP certifications, regulatory approvals (FDA, EMA, WHO), and audit reports to ensure compliance with international quality standards.
3. Can I source generic mefenamic acid at a lower cost?
Yes, numerous generic manufacturers offer mefenamic acid at competitive prices while maintaining compliance with quality standards.
4. Are there supply chain risks associated with sourcing from Chinese or Indian manufacturers?
Potential risks include geopolitical factors, regulatory changes, and raw material availability, emphasizing the importance of supplier diversification.
5. How can I ensure the API's compatibility with my formulation process?
Work closely with the supplier for detailed specifications, stability data, and conduct verification batches before large-scale production.
Sources:
- [1] Solara Active Pharma Sciences Ltd. official website.
- [2] Nanjing Zelangen Pharmaceutical Co., Ltd. product data sheets.
- [3] Indian Pharmaceutical Market Reports.
- [4] European Medicines Agency data on NSAID manufacturing standards.
- [5] Global API supply chain analyses and market trend reports.
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