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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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

Secnidazole is a nitroimidazole class antimicrobial agent widely used to treat protozoal infections such as bacterial vaginosis, trichomoniasis, and amebiasis. Its efficacy stems from its ability to disrupt DNA synthesis in susceptible microorganisms. As demand for effective antiparasitic and antimicrobial treatments increases globally, securing reliable suppliers for Secnidazole is crucial for pharmaceutical companies, generic manufacturers, and healthcare providers. This article examines key suppliers, manufacturing sources, and the market landscape for Secnidazole, offering insights to industry stakeholders seeking secure and quality-assured procurement.

Overview of Secnidazole as a Pharmaceutical Substance

Secnidazole's chemical formula is C₇H₁₀ClN₃O₃, with a molecular weight of approximately 211.63 g/mol. It is administered orally, often as granules or tablets, and has gained prominence due to its favorable pharmacokinetics, including a long half-life that enables single-dose regimens. The drug's inclusion in the WHO Essential Medicines List highlights its global importance (WHO, 2022).

Manufacturing involves complex chemical synthesis, requiring high purity and strict quality control. Consequently, suppliers must adhere to Good Manufacturing Practices (GMP) standards, especially when serving regulated markets such as North America, Europe, and Japan.

Global Suppliers and Manufacturers of Secnidazole

1. Origin and Non-Patent Manufacturers

Several reputable pharmaceutical ingredients (API) manufacturers supply Secnidazole globally. Many operate from regions with mature pharmaceuticalchemical industries, notably India, China, and Europe.

India

India remains a dominant player in the production of generic APIs due to its extensive manufacturing infrastructure and cost advantages. Leading Indian API manufacturers for Secnidazole include:

Hetero Labs: One of India's larger APIs producers, Hetero supplies Secnidazole API compliant with international standards. The company emphasizes quality assurance, GMP certifications, and export readiness.
Anar Industries: Specializes in synthesizing nitroimidazoles, including Secnidazole, with established export channels to North America and Europe.
Shilpa Medicare: Noted for high-quality APIs, Shilpa offers Secnidazole suitable for generic drug formulations.

China

Chinese API manufacturers have expanded their global footprint by increasing capacity and adhering to regulatory standards.

North China Pharmaceutical Group (NCPC): Provides Secnidazole APIs that meet international quality benchmarks.
Zhejiang Langhua Pharmaceutical: Supplies Secnidazole API with a focus on Asia-Pacific markets but expanding globally.
Ruihua Pharmaceutical: Engages in synthesis and export of antimicrobial APIs, including Secnidazole.

Europe

European manufacturers are often preferred for high-value markets due to stringent regulatory compliance.

Siegfried AG (Switzerland): Offers APIs and intermediates, including Secnidazole, with certified quality standards.
BASF: While primarily a chemical company, BASF supplies active pharmaceutical ingredients through its custom manufacturing services.

2. Contract Manufacturing Organizations (CMOs) and Custom Synthesis

Some pharmaceutical companies leverage CMOs for Secnidazole synthesis to ensure quality and supply chain security.

Recipharm and Patheon: These global CMOs can produce Secnidazole on a contract basis, adhering to GMP standards for regulated markets.

3. Key Differences Among Suppliers

Suppliers vary in terms of:

Quality Certifications: GMP, ISO 9001, and FDA registration influence supplier credibility.
Scale and Capacity: Larger manufacturers offer consistent supply for high-volume needs.
Regulatory Compliance: Suppliers with validated cGMP processes meet strict regulatory demands.
Price Competitiveness: Cost-effective sourcing depends on regional manufacturing costs and volume negotiations.

Market Considerations for Secnidazole Suppliers

Regulatory Approvals

Manufacturers must ensure API compliance with target markets' regulatory frameworks, including DMF (Drug Master File) submissions, certificate of suitability (CEPA), or equivalent documentation. Approved suppliers are preferred by pharmaceutical firms for formulation.

Quality Assurance

High purity (generally >98%) and traceability are non-negotiable. Suppliers should provide comprehensive analytical data, stability profiles, and regulatory documentation.

Supply Chain Reliability

Given the urgency often associated with antimicrobial products, established suppliers with reliable production schedules and logistics networks are favored.

Emerging Trends in Secnidazole Supply

Increased Production due to COVID-19 Impact: The pandemic underscored the need for diversified supply chains for antimicrobials, prompting expansion of API manufacturing capacities.
Shift Toward API Synthesis Automation: Improved synthetic methods are reducing costs and enhancing purity levels.
Regulatory Harmonization: Global harmonization initiatives facilitate easier cross-border supplier acceptance.

Where to Source Secnidazole

Direct from Manufacturers: Engaging with Indian, Chinese, or European API producers for bulk supply.
API Distributors and Traders: Connecting via established pharmaceutical ingredient marketplaces such as ChemSpider, Alibaba, or specialized chemical API brokers.
Contract Manufacturing: Partnering with CMOs once specifications are aligned.

Quality and Due Diligence

Investors and pharmaceutical companies must conduct rigorous supplier audits, verify regulatory dossiers, and request stability data to mitigate risks associated with substandard quality or supply shortages.

Conclusion

Secnidazole remains a critical antimicrobial agent with a diverse supply landscape. India and China dominate as primary API producers, complemented by European high-quality suppliers for regulated markets. Establishing reliable supplier relationships relies on rigorous quality assurance, regulatory compliance, and supply chain robustness.

Key Takeaways

Market Dynamics: India and China lead in Secnidazole API manufacturing, with Europe offering high-compliance options.
Supplier Selection: Prioritize GMP-certified manufacturers with proven regulatory track records to mitigate quality risks.
Supply Chain Security: Diversify suppliers to prevent disruptions, especially for essential antimicrobials like Secnidazole.
Regulatory Considerations: Ensure suppliers have proper documentation, such as DMFs and API certificates, for seamless market access.
Future Trends: Growing focus on automation, capacity expansion, and regulatory harmonization will shape the Secnidazole supplier landscape.

FAQs

Q1: What are the leading global suppliers of Secnidazole API?
A1: Prominent suppliers include Indian manufacturers like Hetero Labs, Anar Industries, and Shilpa Medicare; Chinese API producers such as NCPC and Zhejiang Langhua Pharmaceutical; and European firms like Siegfried AG, all adhering to GMP standards.

Q2: How can I verify the quality of a Secnidazole supplier?
A2: Verify certifications (GMP, ISO), request analytical and stability data, review regulatory approvals, and conduct site audits or third-party inspections.

Q3: Is Secnidazole available from contract manufacturing organizations?
A3: Yes, CMOs like Recipharm and Patheon can produce Secnidazole on demand, ensuring quality and supply flexibility.

Q4: What regulatory considerations are involved in sourcing Secnidazole APIs?
A4: Suppliers should have validated DMFs, API Certificates of Analysis, and compliance with target market regulations like FDA or EMA standards.

Q5: What are the future trends affecting Secnidazole suppliers?
A5: Capacity expansion, automation in synthesis, and increased regulatory harmonization are shaping the supply landscape, improving quality and reducing costs.

Sources

[1] WHO. (2022). WHO Model List of Essential Medicines. World Health Organization.
[2] Indian Pharmaceutical Alliance. (2021). Indian API Industry Report.
[3] Chinese Pharmaceutical Industry Association. (2022). Annual Industry Report.
[4] BASF. (2022). API Manufacturing Capabilities. BASF Official Website.

Suppliers and packagers for generic pharmaceutical drug: SECNIDAZOLE

SECNIDAZOLE

Suppliers for the Pharmaceutical Drug: Secnidazole