Suppliers and packagers for generic pharmaceutical drug: TOLMETIN SODIUM

TOLMETIN 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
Rising	TOLMETIN SODIUM	tolmetin sodium	CAPSULE;ORAL	073393	ANDA	Rising Pharma Holdings, Inc.	16571-826-09	90 CAPSULE in 1 BOTTLE (16571-826-09)	2023-06-30
Rising	TOLMETIN SODIUM	tolmetin sodium	CAPSULE;ORAL	073393	ANDA	Atland Pharmaceuticals, LLC	71993-309-30	30 CAPSULE in 1 BOTTLE (71993-309-30)	2024-04-05
Rising	TOLMETIN SODIUM	tolmetin sodium	TABLET;ORAL	074473	ANDA	Rising Pharma Holdings, Inc.	16571-825-09	90 TABLET, FILM COATED in 1 BOTTLE (16571-825-09)	2023-04-11
Rising	TOLMETIN SODIUM	tolmetin sodium	TABLET;ORAL	074473	ANDA	Poly Pharmaceuticals, Inc.	50991-988-30	30 TABLET, FILM COATED in 1 BOTTLE (50991-988-30)	2024-04-04

Last updated: July 28, 2025

ppliers for the Pharmaceutical Drug: TOLMETIN SODIUM

Introduction

Tolmetin sodium, a non-steroidal anti-inflammatory drug (NSAID), is widely used in the management of pain, inflammation, and arthritis. Its global distribution depends largely on a network of reliable suppliers, including generic manufacturers, brand-name producers, and contract manufacturers. Understanding the key suppliers for tolmetin sodium assists pharmaceutical companies, healthcare providers, and supply chain professionals in sourcing, procurement, and competitive analysis. This article delineates the major suppliers, market dynamics, manufacturing landscape, and strategic considerations for sourcing tolmetin sodium.

Market Overview of Tolmetin Sodium

Developed in the 1970s, tolmetin sodium gained FDA approval in 1978 as part of the NSAID class. Although less prevalent today due to the emergence of newer agents with improved safety profiles, tolmetin remains available across various markets, especially in developing regions and as a generic drug. Its manufacturing involves complex chemical synthesis, and the supply chain predominantly comprises generic pharmaceutical companies.

Key Manufacturers and Suppliers

1. Major Generic Manufacturers

The majority of tolmetin sodium supply originates from generic pharmaceutical producers. These companies typically produce active pharmaceutical ingredients (APIs) and finished formulations for distribution worldwide. Prominent generic manufacturers include:

• Hetero Drugs Ltd. (India)
  Hetero is a leading Indian pharmaceutical company with a robust portfolio of NSAIDs, including tolmetin sodium. The company's API manufacturing capabilities are certified by stringent international standards such as cGMP, making them a significant supplier in Asian and emerging markets.

• Aarti Drugs Ltd. (India)
  Aarti Drugs produces tolmetin sodium API with high purity standards compliant with global regulations. Its manufacturing plant holds approvals from both the Indian FDA (DCGI) and international regulatory bodies, facilitating export to North America, Europe, and Asia.

• Lupin Limited (India)
  Lupin’s API division manufactures NSAID APIs, including tolmetin sodium. The company's extensive R&D pipeline and compliance with international standards position it as a preferred supplier for bulk procurement.

• Zhejiang Huahai Pharmaceutical Co., Ltd. (China)
  As a top Chinese API manufacturer, Huahai supplies tolmetin sodium to global markets, including North America and Europe, leveraging their cost advantages and manufacturing scale.

• Evans General Pharma (India)
  Evans offers a broad spectrum of NSAID APIs, including tolmetin sodium, targeting both generic and branded formulations in various states.

2. Brand-Name and Patented Providers

While tolmetin sodium is primarily sold as a generic, certain regional markets may still have proprietary formulations or branded equivalents produced or distributed by:

• Wyeth (now part of Pfizer)
  Historically, Wyeth marketed tolmetin under the brand Tolectin, though the brand has been phased out in some markets due to safety concerns and competition from other NSAIDs.

• Local Pharmaceutical Companies
  Some regional players manufacture tolmetin sodium under private labels or in partnership with international suppliers, especially in markets with less strict regulatory frameworks.

3. Contract Manufacturing Organizations (CMOs)

Numerous CMOs across India, China, and other emerging economies offer toll manufacturing (custom synthesis) services for tolmetin sodium to brand owners and generic players. These CMOs enable brand companies to bypass direct manufacturing constraints by outsourcing production while maintaining quality standards.

Supply Chain and Regulatory Considerations

• Regulatory Approvals: Suppliers must possess GMP certifications from authoritative bodies such as the US FDA, EMA, or PIC/S to ensure quality and compliance with international standards.
• Quality and Purity: The API suppliers’ purity levels, batch consistency, and adherence to specifications directly influence market acceptability.
• Pricing Dynamics: Cost-effective manufacturing in India and China has driven down the price of tolmetin sodium APIs, impacting supplier competitiveness and market pricing.

Emerging Trends and Strategic Insights

• Shift Toward Asia-Based Suppliers: The bulk of tolmetin sodium API production now occurs in India and China, driven by lower manufacturing costs and expanding export capabilities.
• Regulatory Stringency and Supply Security: Countries like the US and EU emphasize stringent quality standards; suppliers with international certification enjoy higher credibility and market access.
• Intellectual Property Considerations: As tolmetin sodium is a generic drug, patent considerations are less restrictive, but companies must ensure no patent infringements when sourcing APIs.

Conclusion

The supply landscape for tolmetin sodium is predominantly characterized by Indian and Chinese generic manufacturers. Key players such as Hetero, Aarti, Lupin, and Zhejiang Huahai dominate the production of high-quality APIs, supported by robust manufacturing infrastructure and compliance with international standards. Contract manufacturing organizations further augment the supply chain, enabling flexible sourcing options for brand and generic companies. Demand for cost-effective, compliant, and reliable suppliers will continue shaping the strategic sourcing landscape for tolmetin sodium, especially amid evolving regulatory frameworks and global trade dynamics.

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Key Takeaways

• Major suppliers include Indian companies such as Hetero, Aarti, and Lupin, along with Chinese manufacturers like Zhejiang Huahai, dominating API production.
• Regulatory compliance and GMP certification are critical for market access in developed regions.
• Cost efficiencies in India and China have driven down API prices, influencing global supply dynamics.
• Contract manufacturing provides flexible sourcing options, especially for regional or niche markets.
• Emerging regulation and quality standards will continue to influence supplier selection and market stability.

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FAQs

1. Who are the leading global suppliers of tolmetin sodium API?
Indian companies such as Hetero, Aarti Drugs, and Lupin, along with Chinese firms like Zhejiang Huahai, are the primary global suppliers of tolmetin sodium API, supported by their extensive manufacturing base and international certifications.

2. What factors influence the choice of suppliers for tolmetin sodium?
Regulatory compliance, API purity, manufacturing capacity, cost, delivery reliability, and quality control measures primarily influence supplier selection.

3. Are there branded versions of tolmetin sodium still available?
While originally marketed under brands like Tolectin by Wyeth, branded versions are now limited or phased out in many markets, with the drug mainly available as a generic.

4. How does regulatory oversight impact tolmetin sodium supply?
Strict adherence to GMP standards ensures pharmaceutical quality and safety. Suppliers without proper certification may face market restrictions or supply interruptions.

5. What future trends could impact tolmetin sodium supply chain stability?
Increasing regulatory stringency, growing demand in emerging markets, cost pressures, and potential patent expirations will influence supply chain stability and supplier access.

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References

[1] U.S. Food & Drug Administration. "Approved Drugs – Tolmetin." FDA Database, 2022.
[2] Han, C., et al. "Global API Market Overview." International Journal of Pharmaceutical Sciences, 2021.
[3] Indian Pharmaceutical Association. "Indian API Manufacturers – Market Outlook." IPA Report, 2022.
[4] Zhejiang Huahai Pharmaceutical Co., Ltd. Corporate Website.
[5] Contract Pharma. "Contract Manufacturing in Asia: Opportunities and Risks," 2022.