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Suppliers and packagers for etodolac
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etodolac
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Ani Pharms | ETODOLAC | etodolac | CAPSULE;ORAL | 075126 | ANDA | A-S Medication Solutions | 50090-2132-1 | 21 CAPSULE in 1 BOTTLE (50090-2132-1) | 2015-02-01 |
| Ani Pharms | ETODOLAC | etodolac | CAPSULE;ORAL | 075126 | ANDA | ANI Pharmaceuticals, Inc. | 62559-250-01 | 100 CAPSULE in 1 BOTTLE (62559-250-01) | 2015-03-09 |
| Ani Pharms | ETODOLAC | etodolac | CAPSULE;ORAL | 075126 | ANDA | ANI Pharmaceuticals, Inc. | 62559-251-01 | 100 CAPSULE in 1 BOTTLE (62559-251-01) | 2015-02-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Etodolac
Overview of Etodolac
Etodolac is a nonsteroidal anti-inflammatory drug (NSAID) widely used in the management of pain and inflammation associated with conditions such as osteoarthritis and rheumatoid arthritis. Developed in the early 1980s, etodolac’s selective inhibition of cyclooxygenase-2 (COX-2) provides effective anti-inflammatory effects with a comparatively reduced risk of gastrointestinal side effects typical of traditional NSAIDs [1]. Its market presence is sustained by a global network of manufacturers and distributors, comprising branded pharmaceutical companies, generic manufacturers, and API (active pharmaceutical ingredient) suppliers.
Global Manufacturing and Supply Landscape
The supply chain for etodolac encompasses API producers, formulation manufacturers, and distribution channels. This article discusses the key suppliers, along with geographic trends, emphasizing the importance for pharmaceutical companies and healthcare providers to understand the landscape for procurement strategies, risk management, and regulatory compliance.
Major API Suppliers of Etodolac
1. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)
Zhejiang Hisun Pharmaceutical is among the leading API producers of etodolac. The company operates multiple cGMP-compliant production facilities with extensive capacity for NSAID APIs, including etodolac. Their offerings are exported globally, primarily targeting North America, Europe, and Asia markets. Hisun’s integration of API manufacturing with formulation capabilities gives it a strategic advantage in supply stability.
2. Mylan N.V. (Now part of Viatris) (India/Global)
Mylan, now integrated into Viatris, has a significant presence in the production of NSAID APIs, including etodolac. The company's manufacturing facilities in India serve as major hubs for affordable generics. Their API is widely used by generic drug manufacturers worldwide, benefiting from the company’s extensive distribution network.
3. Emcure Pharmaceuticals (India)
Emcure is among prominent Indian API producers with a diversified portfolio of NSAIDs, including etodolac. Their facilities are certified by global regulatory agencies such as the US FDA, EMA, and WHO, ensuring compliance for international markets. Emcure supplies both APIs and finished dosage forms.
4. Zhejiang Huahai Pharmaceutical (China)
Another Chinese API supplier, Zhejiang Huahai, offers etodolac alongside a broad spectrum of pharmaceutical APIs. Huahai has committed significant investments to expand their NSAID production capacity, with strict adherence to cGMP standards and environmental regulations. Their API exports target Asia, Africa, and Latin American markets.
5. Aurobindo Pharma (India)
Aurobindo manufactures etodolac API, leveraging their large-scale facilities in India to produce high-quality APIs for export. Their production incorporates advanced purification and quality control measures, aligning with international regulatory standards.
Implications of Supplier Diversity
The global distribution of etodolac API suppliers, primarily concentrated in China and India, reflects the cost-effective manufacturing landscape. This geographic distribution poses certain risks, such as supply disruptions due to regulatory changes, geopolitical tensions, or pandemics. Pharmaceutical companies often mitigate these vulnerabilities by establishing diversified supplier relationships or maintaining strategic inventories.
Formulation and Finished Dosage Form Suppliers
Aside from raw API suppliers, several pharmaceutical companies manufacture and distribute etodolac in finished dosage forms, including tablets and capsules. Notable players include:
- AbbVie (formerly Abbott Laboratories) – Offers branded etodolac in select markets.
- Zydus Cadila (India) – Supplies generic formulations.
- Sun Pharma (India) – Provides both generic formulations and API.
These companies source APIs either directly from key API manufacturers or through global distributors, emphasizing the importance of supply chain transparency and regulatory compliance.
Regulatory Considerations & Certification
Suppliers of etodolac must possess requisite certifications, including:
- US FDA compliance, allowing API and drug manufacturing for US markets.
- EMA certification for European Union markets.
- WHO GMP certification for global distribution.
Regulatory approval impacts market access and influences supplier selection, with a preference toward suppliers adhering to international standards.
Key Factors Influencing Supplier Selection
- Quality Assurance: Suppliers must meet stringent cGMP standards, with verifiable quality control processes.
- Cost Competitiveness: Price competitiveness remains crucial, especially for generics markets.
- Supply Reliability: Capacity, production flexibility, and historical supply track record.
- Regulatory Compliance: Certificates, documentation, and adherence to regional standards.
- Geographic Considerations: Potential geopolitical risks and logistical factors.
Conclusion
The etodolac supply landscape is characterized by a robust network of Chinese and Indian API manufacturers, supported by global formulators and finished dosage producers. Strategic procurement depends on quality, regulatory adherence, and supply chain resilience. Continuous monitoring of geopolitical developments and manufacturing capacities is essential for stakeholders seeking a reliable etodolac supply.
Key Takeaways
- Chinese and Indian API suppliers dominate the etodolac manufacturing landscape, offering cost-effective options for global markets.
- Major API suppliers include Zhejiang Hisun Pharmaceutical, Mylan (Viatris), Emcure Pharmaceuticals, Zhejiang Huahai, and Aurobindo Pharma.
- Diversification of suppliers reduces supply chain risks associated with geopolitical or regulatory disruptions.
- Certification and regulatory compliance are critical for supplier qualification, especially for markets such as the US and EU.
- Formulation manufacturers leverage both APIs directly from API producers and third-party distributors, emphasizing regulatory standards and supply reliability.
FAQs
1. What are the primary regions manufacturing etodolac APIs?
China and India are the primary regions, hosting leading API manufacturers such as Zhejiang Hisun and Aurobindo Pharma, due to their cost-effective production capacities and regulatory standards.
2. How do suppliers ensure the quality of etodolac APIs?
Suppliers adhere to international standards like cGMP, obtain certifications from agencies such as the US FDA and EMA, and implement rigorous quality control measures throughout manufacturing.
3. What are the risks associated with sourcing etodolac APIs from China and India?
Risks include supply disruptions due to geopolitical tensions, regulatory changes, environmental policies, or pandemics, which can impact production or export capabilities.
4. How can pharmaceutical companies mitigate supply chain risks for etodolac?
By diversifying supplier sources across regions, maintaining strategic inventories, and establishing long-term agreements with multiple approved suppliers.
5. Are there any notable regulatory hurdles for new API suppliers of etodolac?
Yes, new suppliers must acquire requisite certifications (e.g., cGMP, US FDA approval) and demonstrate quality consistency, which can be resource-intensive and time-consuming.
References
[1] Rainsford, K.D. (2017). "Anti-Inflammatory and Anti-Rheumatic Drugs." In: Pharmaceutics. Elsevier.
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