Suppliers and packagers for generic pharmaceutical drug: meclofenamate sodium

meclofenamate sodium

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mylan	MECLOFENAMATE SODIUM	meclofenamate sodium	CAPSULE;ORAL	071081	ANDA	Mylan Pharmaceuticals Inc.	0378-2150-01	100 CAPSULE in 1 BOTTLE, PLASTIC (0378-2150-01)	1986-09-03
Mylan	MECLOFENAMATE SODIUM	meclofenamate sodium	CAPSULE;ORAL	071081	ANDA	Mylan Pharmaceuticals Inc.	0378-3000-01	100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3000-01)	1986-09-03

Suppliers for the Pharmaceutical Drug: MECLOFENAMATE SODIUM

Last updated: July 29, 2025

Introduction

Meclofenamate Sodium, a non-steroidal anti-inflammatory drug (NSAID), is primarily used for its analgesic and anti-inflammatory properties. It belongs to the class of acetic acid derivatives, with specific applications in treating musculoskeletal conditions such as arthritis, bursitis, and other inflammatory disorders. The global pharmaceutical supply chain encompasses numerous suppliers of Meclofenamate Sodium, ranging from active pharmaceutical ingredient (API) producers to finished drug manufacturers. Understanding the key suppliers is critical for stakeholders involved in procurement, manufacturing, and regulatory approval processes.

Global API Suppliers of Meclofenamate Sodium

The production of Meclofenamate Sodium hinges on specialized chemical synthesis processes, necessitating high purity and stringent quality controls. Several companies worldwide are recognized as primary API suppliers, often operating under strict Good Manufacturing Practice (GMP) standards to meet international regulatory requirements.

Major API Producers

1. Zhejiang Greenstone Pharmaceutical Co., Ltd. (China)
   A leading manufacturer specializing in NSAID APIs, Zhejiang Greenstone manufactures Meclofenamate Sodium with a focus on high purity and consistent supply. Its products are widely exported and used by pharmaceutical companies globally.

2. Hangzhou Green Medicinal Co., Ltd. (China)
   Known for its broad portfolio of NSAID APIs, Hangzhou Green Medicinal supplies high-quality Meclofenamate Sodium to international markets, emphasizing GMP compliance and robust quality assurance.

3. Northeast Pharmaceutical Group Co., Ltd. (China)
   A prominent Chinese API manufacturer with extensive experience in NSAID synthesis, Northeast Pharmaceutical offers Meclofenamate Sodium in various grades suited for bulk pharmaceutical production.

4. CordenPharma (Germany)
   Although better known for custom synthesis, CordenPharma produces complex APIs for global clients, including NSAID derivatives. Its GMP-certified manufacturing facilities ensure high-quality standards.

5. Aurobindo Pharma Ltd. (India)
   A major Indian pharmaceutical manufacturer, Aurobindo supplies Meclofenamate Sodium API, leveraging its extensive manufacturing capacity and export network.

Emerging API Suppliers

• Several smaller Chinese and Indian API manufacturers also supply Meclofenamate Sodium, typically targeting regional markets or specializing in niche formulations. These include companies such as Hubei Wujing Pharmaceutical Co., Ltd. and Torrent Pharmaceuticals.

Finished Dosage Form Manufacturers

Beyond raw API supply, numerous pharmaceutical companies incorporate Meclofenamate Sodium into finished formulations. These firms may source APIs globally and manufacture tablets, capsules, or suspensions for regional or international markets.

1. Pfizer Inc.
   Pfizer maintains a portfolio of NSAID-based products, often sourcing APIs from reputable Chinese and Indian suppliers, including Meclofenamate Sodium, for their generic or branded formulations.

2. Sun Pharmaceutical Industries Ltd.
   As one of India’s leading pharmaceutical firms, Sun Pharma produces finished dosage forms containing Meclofenamate Sodium, often utilizing API supplies from Indian or Chinese manufacturers.

3. Cipla Limited
   Known for affordable generics, Cipla incorporates Meclofenamate Sodium into its NSAID product lines, sourcing APIs globally.

4. Dr. Reddy’s Laboratories
   Operating a comprehensive manufacturing network, Dr. Reddy's Often integrates imported APIs into its formulations, including Meclofenamate Sodium.

Key Considerations for Suppliers

• Regulatory Compliance: Suppliers must adhere to international standards such as GMP, ISO, and potentially cGMP certifications, depending on the market.

• Quality Assurance: High purity and consistent API quality are paramount, especially to meet regulatory clearance in major markets like the U.S. (FDA), Europe (EMA), and Japan (PMDA).

• Supply Stability: The complexity of manufacturing NSAID APIs makes steady supply crucial, especially considering volatility in raw material availability.

• Price & Logistics: Competitive pricing coupled with reliable logistics influences procurement decisions, particularly for generic drug manufacturers.

Market Dynamics and Trends

• Geographical Shifts: Chinese and Indian API manufacturers dominate the Meclofenamate Sodium supply chain, driven by cost advantages and manufacturing capacity.

• Regulatory Scrutiny: Increasing regulatory oversight has prompted suppliers to bolster quality systems and transparency to gain approvals in Western markets.

• Innovation & Custom Synthesis: Increasingly, suppliers investing in process innovation can ensure better yields and purity, providing competitive advantages.

Conclusion

The supply landscape for Meclofenamate Sodium is predominantly characterized by Chinese and Indian API producers, complemented by European firms with advanced manufacturing facilities. The selection of suppliers hinges on regulatory compliance, consistent quality, cost considerations, and supply reliability. For pharmaceutical companies, fostering strong partnerships with certified suppliers ensures uninterrupted access to this NSAID, essential for both generic and branded product portfolios.

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Key Takeaways

• Leading API Suppliers: Chinese companies like Zhejiang Greenstone and Hangzhou Green Medicinal are primary sources, complemented by Indian firms such as Aurobindo Pharma.
• Quality & Compliance: Ensuring GMP certification and adherence to international standards is critical in supplier selection.
• Global Market Trends: Chinese and Indian suppliers dominate due to cost advantages, but regulatory scrutiny is increasing.
• Supply Chain Stability: Long-term contracts and supplier audits mitigate risks associated with API supply disruptions.
• Strategic Sourcing: Diversified supplier bases reduce dependency on single manufacturing sources and enhance supply resilience.

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FAQs

1. What are the main raw material sources for Meclofenamate Sodium production?
The synthesis of Meclofenamate Sodium primarily relies on aromatic compounds such as diflunisal derivatives and specific acetic acid intermediates, sourced either locally or imported by API manufacturers.

2. Are there any US or European API suppliers for Meclofenamate Sodium?
While most manufacturing is concentrated in China and India, a few European companies like CordenPharma produce high-quality NSAID APIs, but they are less prevalent due to higher production costs.

3. What quality certifications should API suppliers for Meclofenamate Sodium possess?
Suppliers should hold GMP certification compliant with FDA or EMA regulations, along with ISO 9001 quality management systems. Good Manufacturing Practices ensure API safety, purity, and efficacy.

4. How does regulatory compliance impact the procurement of Meclofenamate Sodium APIs?
Regulatory compliance ensures that APIs meet safety, efficacy, and quality standards required by health authorities, enabling manufacturers to obtain necessary approvals for finished products.

5. What factors influence contract negotiations with API suppliers?
Pricing, supply reliability, quality assurance, lead times, logistical support, and regulatory track record are critical factors influencing negotiations and long-term procurement agreements.

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References

1. U.S. Food & Drug Administration (FDA). Guidance on GMP for APIs.
2. European Medicines Agency (EMA). Good Manufacturing Practice (GMP) for Medicinal Products.
3. Market research reports on NSAID API manufacturing by IQVIA and Global Market Insights.
4. Company disclosures and product catalogs from Zhejiang Greenstone Pharmaceutical Co., Ltd., Hangzhou Green Medicinal Co., Ltd., and other listed suppliers.