Suppliers and packagers for indomethacin

indomethacin

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amneal Pharms	INDOMETHACIN	indomethacin	CAPSULE, EXTENDED RELEASE;ORAL	091549	ANDA	Amneal Pharmaceuticals LLC	65162-506-03	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-03)	2010-12-06
Amneal Pharms	INDOMETHACIN	indomethacin	CAPSULE, EXTENDED RELEASE;ORAL	091549	ANDA	Amneal Pharmaceuticals LLC	65162-506-06	60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-06)	2010-12-06
Amneal Pharms	INDOMETHACIN	indomethacin	CAPSULE, EXTENDED RELEASE;ORAL	091549	ANDA	Amneal Pharmaceuticals LLC	65162-506-09	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-09)	2010-12-06

Suppliers for the Pharmaceutical Drug: Indomethacin

Last updated: July 28, 2025

Introduction

Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) widely used to treat pain, inflammation, and gout. Its efficacy depends heavily on reliable suppliers capable of meeting stringent regulatory standards, ensuring consistent quality, and maintaining supply chain security. As global demand persists, understanding the landscape of Indomethacin suppliers is critical for pharmaceutical companies, healthcare providers, and regulatory agencies.

Global Market Overview

Indomethacin's manufacture is concentrated largely in regions with advanced pharmaceutical manufacturing capabilities—primarily India, China, and to a lesser extent, Europe and North America. India's pharmaceutical sector, known for its cost-effective production and broad export reach, is home to many of the principal suppliers. China complements this with significant bulk chemical manufacturing, often supplying raw ingredients (APIs). European and North American companies typically focus on finished dosage forms or specialized API manufacturing adhering to rigorous regulatory frameworks.

Key API Manufacturers and Suppliers

1. Zhejiang Kangle Pharmaceutical Co., Ltd. (China)
   Kangle Pharmaceutical specializes in the synthesis of NSAID APIs, including Indomethacin. The company invests heavily in R&D to enhance yield and purity, aligning with global Good Manufacturing Practices (GMP). They export predominantly to India and Southeast Asia.

2. Hainan Guanghua Pharmaceutical Co., Ltd. (China)
   This manufacturer produces bulk Indomethacin as well as finished pharmaceutical formulations. Their APIs meet European and FDA standards, offering competitive pricing and flexible batch sizes for large pharmaceutical companies.

3. Sun Pharmaceutical Industries Ltd. (India)
   Sun Pharma is a leading producer of Indomethacin API, with facilities adhering to international quality standards. Their global footprint ensures a stable supply chain backed by strong regulatory compliance including USFDA, EDQM, and others.

4. Morningside Pharmaceuticals (UK/Hong Kong)
   While primarily known for finished products, Morningside also sources high-quality APIs, including Indomethacin, from verified Chinese manufacturers and supplies to European markets.

5. Indo Thai Synthetics Ltd. (India)
   An established API manufacturer with ISO certifications, Indo Thai Synthetics produces Indomethacin APIs for domestic use and export, maintaining compliance with international pharmacopoeias.

6. Honjo Pharmaceutical Co., Ltd. (Japan)
   Although larger focus is on regional markets, Honjo's high standards for API manufacturing include Indomethacin, emphasizing purity and consistent supply.

Suppliers of Finished Dosage Forms

Some companies manufacture pre-formulated Indomethacin tablets or capsules, often sourcing the API from global suppliers.

• TEVA Pharmaceuticals (Israel): Produces generic Indomethacin in multiple dosages.
• Mylan (now part of Viatris): Offers finished formulations for international markets.
• Krka Pharmaceuticals (Slovenia): Supplies branded and generic Indomethacin formulations, often sourcing APIs from Indian and Chinese manufacturers.

Regulatory and Quality Considerations

Reliability hinges on adherence to pharmacopoeial standards such as US Pharmacopeia (USP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP). Many suppliers have obtained certifications like WHO-GMP, ISO 9001, and adherence to ICH guidelines, supporting compliance with regulatory requirements across markets.

buyers should scrutinize supply chain documentation, batch records, and third-party audit reports to verify quality standards, especially when engaging with Chinese and Indian manufacturers, where regulatory oversight varies.

Supply Chain Dynamics and Challenges

Global disruptions, including the COVID-19 pandemic, have spotlighted vulnerabilities in API supply chains for critical drugs like Indomethacin. Dependence on a limited number of suppliers heightens risk. To mitigate this, pharmaceutical companies diversify their supplier base, establish dual sourcing strategies, and emphasize long-term contracts with verified manufacturers.

Furthermore, the trend toward active pharmaceutical ingredient (API) vertical integration benefits large companies seeking stable supplies. Smaller manufacturers face challenges maintaining consistent quality and supply due to capacity constraints or regulatory hurdles.

Emerging Suppliers and Future Directions

Innovation continues in APIs manufacturing, with some startups and established players investing in greener synthesis methods, improved yields, and enhanced quality control. Additionally, regional regulatory harmonization efforts aim to streamline approvals and boost supply chain transparency.

Conclusion

The supply landscape for Indomethacin encompasses a diverse range of manufacturers primarily located in India and China, supported by regional leaders in Europe and Japan. Ensuring a reliable and compliant supply chain demands meticulous due diligence, regulatory adherence, and strategic sourcing. As global demand persists, building resilient partnerships with qualified suppliers remains fundamental for healthcare providers and pharmaceutical companies.

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Key Takeaways

• The primary API suppliers for Indomethacin are based in India and China, with additional regional players providing finished products.
• Stringent quality standards and regulatory compliance are essential when selecting suppliers for API or finished formulations.
• Diversification and rigorous supplier evaluation mitigate supply chain risks amid global disruptions.
• Emerging manufacturers focusing on sustainable and innovative synthesis methods could redefine the supply landscape.
• Ongoing regulatory harmonization efforts facilitate international trade and streamline supplier vetting processes.

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FAQs

1. Who are the leading suppliers of Indomethacin API globally?
The leading API manufacturers include Zhejiang Kangle Pharmaceutical and Hainan Guanghua Pharmaceutical in China, as well as Sun Pharma and Indo Thai Synthetics in India. These companies have established global reputations for quality and supply stability.

2. What regulatory standards must suppliers meet for global distribution?
Suppliers should comply with standards such as USFDA, European Pharmacopoeia (EP), Indian Pharmacopoeia (IP), and WHO-GMP certification. These ensure high quality, safety, and efficacy of the API.

3. How can pharmaceutical companies ensure the quality of Indomethacin sources?
Through comprehensive supplier audits, review of GMP certification, batch testing, and validation reports. Establishing contractual quality agreements and ongoing quality monitoring are also critical.

4. Are there any emerging markets or new suppliers in the Indomethacin supply chain?
Yes, several startups and regional manufacturers in Southeast Asia and other emerging markets are entering the space, often focusing on eco-friendly synthesis and higher yields to meet increasing demand.

5. What are the main challenges in sourcing Indomethacin today?
Supply chain disruptions caused by geopolitical tensions, pandemic-related manufacturing delays, and regulatory variances. Additionally, ensuring API quality compliance across different regions remains a persistent challenge.

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Sources

1. [1] "Global API Market for NSAIDs," Pharma Intelligence, 2022.
2. [2] "Indomethacin API Manufacturers," ChemSpider, Royal Society of Chemistry.
3. [3] "Regulatory Standards for APIs," USFDA, 2023.
4. [4] "Indian Pharmaceutical Industry Outlook," Department of Pharmaceuticals, India, 2022.
5. [5] "China's Pharmaceutical API Sector," China National Pharmaceutical Industry Information Center, 2021.