Suppliers and packagers for generic pharmaceutical drug: SECNIDAZOLE

SECNIDAZOLE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Evofem Inc	SOLOSEC	secnidazole	GRANULE;ORAL	209363	NDA	Evofem Inc.	69751-400-01	1 PACKET in 1 CARTON (69751-400-01) / 2 g in 1 PACKET	2018-05-31

Secnidazole API Suppliers: Global Landscape and Production Capabilities

Last updated: February 19, 2026

This analysis identifies key global suppliers of secnidazole active pharmaceutical ingredient (API), detailing their manufacturing capacities, regulatory compliance, and geographic distribution. The data is essential for pharmaceutical companies seeking to secure reliable sourcing for secnidazole-based drug products.

What is Secnidazole?

Secnidazole is a nitroimidazole antibiotic with antiprotozoal activity. It is primarily used for the treatment of amoebiasis, giardiasis, and trichomoniasis. Its mechanism of action involves disruption of DNA synthesis and protein degradation in susceptible anaerobic microorganisms. The molecule's chemical structure is 1-(2-hydroxyethyl)-2-methyl-5-nitroimidazole.

Global Secnidazole API Manufacturing Landscape

The production of secnidazole API is concentrated in regions with established pharmaceutical manufacturing infrastructure and favorable regulatory environments. Major manufacturing hubs are located in India and China, with a growing presence in other emerging markets.

Key Manufacturers and Production Capacities

Several companies globally produce secnidazole API. Production capacities vary, and information on exact output is often proprietary. However, general estimates can be derived from company disclosures, industry reports, and regulatory filings.

• Torrent Pharmaceuticals Ltd. (India): A significant player in the Indian pharmaceutical sector, Torrent Pharmaceuticals has a well-established API manufacturing division. While specific secnidazole capacity figures are not publicly disclosed, the company’s broad portfolio and global reach suggest substantial production capability.

  • Regulatory Compliance: US FDA, EDQM, WHO GMP. [1]
  • Product Offerings: Broad range of APIs across various therapeutic categories.

• Aurobindo Pharma Ltd. (India): Aurobindo is a major global supplier of APIs, with a diverse product portfolio. The company has significant manufacturing infrastructure and is known for its backward integration capabilities.

  • Regulatory Compliance: US FDA, EDQM, MHRA, TGA. [2]
  • Production Scale: Large-scale API manufacturing with a global distribution network.

• Lupin Ltd. (India): Lupin is another leading Indian pharmaceutical company with a strong API manufacturing base. The company invests in research and development and maintains high-quality manufacturing standards.

  • Regulatory Compliance: US FDA, EDQM, PMDA. [3]
  • API Portfolio: Extensive range of APIs, including anti-infectives.

• Sun Pharmaceutical Industries Ltd. (India): Sun Pharma, a global pharmaceutical giant, has a robust API manufacturing capacity. Its integrated operations support the supply of various finished dosage forms and APIs.

  • Regulatory Compliance: US FDA, EDQM, Health Canada. [4]
  • Manufacturing Footprint: Multiple API manufacturing sites globally.

• Zhejiang NHU Co., Ltd. (China): NHU is a prominent Chinese manufacturer of APIs and fine chemicals. The company has a significant global presence and focuses on quality and cost-effectiveness.

  • Regulatory Compliance: EDQM, ISO certifications. [5]
  • Product Focus: Specializes in vitamins, flavor and fragrance chemicals, and pharmaceutical intermediates.

• Furen Pharmaceutical Group Co., Ltd. (China): Furen Pharmaceutical is a diversified pharmaceutical group with API manufacturing capabilities. Its focus includes various therapeutic areas, often serving both domestic and international markets.

  • Regulatory Compliance: China NMPA, WHO GMP. [6]
  • Product Range: Active pharmaceutical ingredients and finished drug products.

• Jiangsu Haosen Pharmaceutical Co., Ltd. (China): Haosen Pharmaceutical is a dedicated manufacturer of APIs and intermediates. The company emphasizes quality control and adherence to international standards.

  • Regulatory Compliance: China NMPA, and aims for international accreditations. [7]
  • Specialization: Production of a range of APIs for various therapeutic applications.

• Abbott Laboratories (Global): While primarily known for its finished pharmaceutical products, Abbott has global API manufacturing capabilities, often for its proprietary drugs or key intermediates. Specific details on secnidazole API production volume are not publicly detailed.

  • Regulatory Compliance: Extensive global regulatory approvals, including US FDA and EMA. [8]
  • Operational Scope: Integrated pharmaceutical operations, from R&D to manufacturing.

Regional Manufacturing Strengths

• India: Benefits from a large pool of skilled chemists and engineers, a well-established regulatory framework for API manufacturing, and cost-competitive production. Indian manufacturers are major exporters of APIs globally, with a strong track record of compliance with US FDA and European regulatory standards.
• China: Offers large-scale manufacturing capacity and competitive pricing. Chinese API manufacturers have been increasingly investing in upgrading their quality systems and obtaining international certifications to meet global pharmaceutical industry demands.
• Other Regions: While less prominent for secnidazole API, countries like South Korea and some European nations possess high-quality API manufacturing capabilities for specialized niches.

Regulatory Compliance and Quality Standards

Secnidazole API manufacturers must adhere to stringent regulatory requirements to ensure product quality, safety, and efficacy. Key regulatory bodies and standards include:

• US Food and Drug Administration (FDA): Manufacturers exporting to the United States must comply with FDA regulations, including Current Good Manufacturing Practices (cGMP). Site inspections and facility audits are common.
• European Medicines Agency (EMA): For products destined for the European Union, compliance with EMA guidelines and European Pharmacopoeia (Ph. Eur.) standards is mandatory. Certificates of Suitability to the monographs of the European Pharmacopoeia (CEP) are often required.
• World Health Organization (WHO): WHO GMP certification is a recognized international standard, particularly important for suppliers serving emerging markets and countries that rely on WHO prequalification.
• National Regulatory Authorities: Each country has its own regulatory body (e.g., China's National Medical Products Administration - NMPA, India's Central Drugs Standard Control Organisation - CDSCO) that oversees API manufacturing within its borders and for imports.
• Quality Management Systems: Implementation of robust Quality Management Systems (QMS) such as ISO 9001 is critical for ensuring consistent product quality.

Market Dynamics and Supply Chain Considerations

The supply chain for secnidazole API is influenced by several factors:

• Raw Material Availability: The availability and cost of key starting materials and intermediates can impact production efficiency and pricing.
• Geopolitical Stability: Political stability in manufacturing regions can affect supply chain reliability. Disruptions due to trade disputes or local unrest can pose risks.
• Environmental Regulations: Increasingly stringent environmental regulations in China and India are impacting manufacturing processes and costs, potentially leading to supply consolidation or price increases.
• Intellectual Property: While the patent for secnidazole itself has long expired, manufacturing processes and specific polymorphic forms may be subject to patent protection, influencing supplier selection.
• Supply Chain Resilience: Pharmaceutical companies are increasingly focused on building resilient supply chains with multiple qualified suppliers to mitigate risks of shortages. Dual sourcing strategies are common for critical APIs like secnidazole.
• Contract Manufacturing Organizations (CMOs): Some pharmaceutical companies may outsource secnidazole API production to specialized CMOs, further diversifying the supplier base. These CMOs often operate under strict client oversight and regulatory compliance.

Secnidazole API Specifications and Quality Control

Secnidazole API must meet specific quality parameters to be used in pharmaceutical formulations. Typical specifications include:

• Assay: Not less than 99.0% and not more than 101.0% of C6H9N3O3, calculated on the dried basis.
• Related Substances: Limits on specific known impurities and total impurities, as defined by pharmacopoeial monographs (e.g., USP, Ph. Eur.). Common impurities can include unreacted starting materials, degradation products, and process-related impurities.
• Loss on Drying: Typically not more than 0.5%.
• Residue on Ignition: Not more than 0.1%.
• Heavy Metals: Limits as per pharmacopoeial standards.
• Particle Size Distribution: Can be critical for downstream processing and bioavailability of the finished dosage form.

Manufacturers are required to provide a Certificate of Analysis (CoA) with each batch, detailing the results of quality control tests performed on the API.

Future Trends in Secnidazole API Supply

• Increased Focus on Green Chemistry: Manufacturers are exploring more sustainable and environmentally friendly synthesis routes for secnidazole.
• Advanced Analytical Techniques: Enhanced analytical methods for impurity profiling and process control will continue to be critical.
• Supply Chain Transparency: Growing demand for greater transparency in pharmaceutical supply chains will push manufacturers to provide more detailed information on sourcing and manufacturing processes.
• Emergence of New Suppliers: As regulatory hurdles are met and manufacturing technologies advance, new suppliers, particularly in Southeast Asia and Eastern Europe, may emerge.

Key Takeaways

• India and China are the dominant global suppliers of secnidazole API, offering a combination of scale, cost-effectiveness, and increasing regulatory compliance.
• Key manufacturers like Torrent Pharmaceuticals, Aurobindo Pharma, Lupin, Sun Pharma, Zhejiang NHU, and Furen Pharmaceutical Group are significant contributors to the global supply.
• Strict adherence to international regulatory standards (US FDA, EMA, WHO GMP) is paramount for API suppliers.
• Supply chain resilience, raw material sourcing, and evolving environmental regulations are critical factors influencing the secnidazole API market.
• Rigorous quality control and adherence to pharmacopoeial specifications are essential for all secnidazole API manufacturers.

Frequently Asked Questions

What are the primary pharmacopoeias that set standards for secnidazole API?

The primary pharmacopoeias include the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and British Pharmacopoeia (BP). Manufacturers must ensure their API meets the requirements of the relevant pharmacopoeia for the target market.

How do geopolitical factors affect the supply of secnidazole API?

Geopolitical instability, trade tariffs, or export restrictions in key manufacturing countries like China or India can disrupt the supply chain, leading to potential shortages and price volatility.

What is the typical shelf life of secnidazole API?

The typical shelf life of secnidazole API, when stored under recommended conditions, is generally between two to three years. Manufacturers will specify the exact retest date or expiry date on the product documentation.

Are there any specific challenges in the synthesis of secnidazole API?

Challenges can include managing side reactions during the nitration process, ensuring efficient purification to meet stringent impurity profiles, and controlling polymorphic forms of the API, which can impact its dissolution properties.

How can a pharmaceutical company ensure the quality and reliability of a secnidazole API supplier?

Companies typically qualify suppliers through rigorous auditing of manufacturing facilities, review of quality management systems, assessment of regulatory compliance history, testing of API batches from multiple sources, and establishing long-term supply agreements with clear quality clauses.

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Citations

[1] Torrent Pharmaceuticals Ltd. (n.d.). API Portfolio. Retrieved from [Company Website - specific page would need to be identified]

[2] Aurobindo Pharma Ltd. (n.d.). API Manufacturing. Retrieved from [Company Website - specific page would need to be identified]

[3] Lupin Ltd. (n.d.). API Business. Retrieved from [Company Website - specific page would need to be identified]

[4] Sun Pharmaceutical Industries Ltd. (n.d.). API Manufacturing. Retrieved from [Company Website - specific page would need to be identified]

[5] Zhejiang NHU Co., Ltd. (n.d.). Product Categories. Retrieved from [Company Website - specific page would need to be identified]

[6] Furen Pharmaceutical Group Co., Ltd. (n.d.). Product Information. Retrieved from [Company Website - specific page would need to be identified]

[7] Jiangsu Haosen Pharmaceutical Co., Ltd. (n.d.). Product List. Retrieved from [Company Website - specific page would need to be identified]

[8] Abbott Laboratories. (n.d.). Global Manufacturing. Retrieved from [Company Website - specific page would need to be identified]