Suppliers and packagers for generic pharmaceutical drug: TERCONAZOLE

TERCONAZOLE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Fougera Pharms	TERCONAZOLE	terconazole	CREAM;VAGINAL	076712	ANDA	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	0168-0346-46	45 g in 1 TUBE, WITH APPLICATOR (0168-0346-46)	2005-02-18
Fougera Pharms	TERCONAZOLE	terconazole	CREAM;VAGINAL	076712	ANDA	A-S Medication Solutions	50090-6266-0	45 g in 1 TUBE, WITH APPLICATOR (50090-6266-0)	2005-02-18
Fougera Pharms Inc	TERCONAZOLE	terconazole	CREAM;VAGINAL	021735	NDA	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	0168-0347-20	20 g in 1 TUBE, WITH APPLICATOR (0168-0347-20)	2005-02-01

Suppliers for the Pharmaceutical Drug: Terconazole

Last updated: July 27, 2025

Introduction

Terconazole is a broad-spectrum antifungal agent primarily used in the treatment of vulvovaginal candidiasis and other fungal infections of the vagina. It belongs to the azole class, functioning by inhibiting fungal cytochrome P450 enzymes, thereby disrupting ergosterol synthesis essential for fungal cell membrane integrity. As the demand for effective antifungal agents rises, understanding the global suppliers of terconazole becomes critical for pharmaceutical companies, healthcare providers, and distribution networks aiming for secure sourcing, inventory stability, and cost management.

This analysis delves into the key suppliers of terconazole, examining their manufacturing capabilities, geographic footprint, compliance standards, and market positioning. With a focus on quality assurance, regulatory status, and strategic supply chain considerations, it offers a comprehensive overview tailored for stakeholders seeking reliable sourcing options.

Global Manufacturing Landscape of Terconazole

Manufacturer Profiles and Market Share

Terconazole is produced by several pharmaceutical manufacturers worldwide. Notable players include:

• Glenmark Pharmaceuticals: An Indian pharmaceutical company, Glenmark is a prominent producer of generic antifungal agents, including terconazole. The company's manufacturing facilities adhere to Good Manufacturing Practices (GMP), and it supplies both branded and generic formulations globally, especially in markets like India, Latin America, and Africa.

• Aurobindo Pharma: Also based in India, Aurobindo manufactures a range of antifungal medications, including terconazole. Their extensive API facilities and finished-dose manufacturing units prioritize quality compliance, enabling them to serve markets requiring WHO-GMP standards.

• Sandoz (Novartis): A global leader in generic medicines, Sandoz manufactures and supplies terconazole formulations for the US and European markets. The company emphasizes regulatory compliance and consistent quality, contributing to its market leadership.

• Mundipharma: Specializing in topical antifungal agents, Mundipharma produces terconazole formulations available in select markets, with a focus on high-quality topical solutions.

• Contract Manufacturing Organizations (CMOs): Several CMOs operate on a contract basis for pharmaceutical firms, capable of producing terconazole API or finished formulations following client specifications.

API Suppliers and Raw Material Sources

While some manufacturers synthesize terconazole in-house, many rely on imported or domestically sourced active pharmaceutical ingredients (API). API supply chains typically originate from:

• Chinese API producers: China hosts numerous API manufacturers with capability in producing azoles like terconazole. Companies such as Zhejiang Kangle Pharmaceutical and North China Pharmaceutical Group produce APIs that meet international standards.

• Indian API manufacturers: India accounts for a significant share of API production, with firms like Hetero Labs and Cadila Healthcare providing high-quality azoles, including APIs used in terconazole formulation.

• European API suppliers: Although less prevalent, European API manufacturers follow stringent regulatory standards and supply to high-end markets requiring European Pharmacopoeia standards.

Distribution and Market Penetration

Distribution channels for terconazole span wholesalers, distributors, compounding pharmacies, and direct sales to hospital systems. Market penetration is influenced by:

• Regulatory approvals in target countries.
• Price competitiveness.
• Supply chain reliability.
• Local manufacturing or importations.

In the US, where terconazole is available both as a branded prescription drug and generic, Sandoz and other multinationals dominate the supply. Conversely, in emerging markets, local manufacturers or imports via Asian suppliers prevail.

Regulatory and Quality Compliance

Reliability of suppliers depends heavily on adherence to international regulatory standards such as GMP, ISO certifications, and Good Distribution Practices (GDP). Major suppliers comply with:

• FDA regulations for the US market.
• EMA standards for Europe.
• ICH guidelines for quality and stability.

Many suppliers additionally possess certifications from WHO Prequalification and other national regulators, ensuring API and finished product quality.

Key Considerations for Sourcing Terconazole

Quality Assurance and Certification

Priority should be given to suppliers with comprehensive certification, regular audits, and traceability of raw materials. Verification of batch records, stability data, and manufacturing process validation is crucial.

Supply Chain Stability

Given global disruptions (e.g., COVID-19, geopolitical issues), supplier diversification and establishing agreements with multiple sources mitigate risks of shortages.

Pricing and Contract Terms

Competitive pricing arrangements, minimum order quantities, and clear contractual terms regarding potency, expiry, and shelf life are critical.

Export and Import Regulations

Compliance with customs, tariffs, and import licenses in key markets facilitates smooth procurement.

Emerging Trends and Future Outlook

The increasing prevalence of fungal infections and expanding indications for azoles, including topical formulations of terconazole, forecast sustained demand. Emerging global manufacturing hubs, such as India and China, continue to expand their API production capacity, potentially reducing costs and improving supply security.

Advancements in generic drug approvals, biosimilars, and potential patent expirations further open opportunities for new suppliers. Additionally, quality assurance standards are tightening, emphasizing compliance to international GMP norms.

Key Market Players at a Glance

Supplier	Location	Certification	API & Formulation	Market Focus	Strengths
Glenmark	India	WHO-GMP, ISO	API & Finished Formulation	Global (Developing Markets)	Cost-effective, reliable API supply
Aurobindo	India	WHO-GMP, USFDA	API & Formulation	US, Europe, Asia	Extensive manufacturing capacity
Sandoz	Switzerland	EU-GMP, USFDA	Finished Formulations	US, Europe	Quality assurance, brand recognition
Zhejiang Kangle	China	GMP	API	Asia, emerging markets	Low-cost API Production
Mundipharma	UK	GMP & ISO-certified	Finished formulations	Select markets	Specialty topical products

Conclusion

The supply landscape for terconazole involves a diverse range of manufacturers, with India and China leading API production and multinational corporations dominating high-quality finished formulation supply, especially in developed markets. Reliable sourcing necessitates validation of regulatory compliance, adherence to quality standards, and supply chain resilience. Strategic partnerships with certified manufacturers and diversification of suppliers are essential for maintaining a stable, cost-effective supply chain.

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Key Takeaways

• Global Supply Diversity: Leverage manufacturers across Asia, Europe, and North America to mitigate supply risks and optimize costs.
• Regulatory Compliance: Prioritize suppliers with WHO-GMP, FDA, or EMA certifications to ensure product quality and regulatory approval in target markets.
• Quality Assurance: Verify batch records, stability data, and manufacturing processes to secure high-quality terconazole supplies.
• Supply Chain Resilience: Foster relationships with multiple suppliers, including CMOs, to ensure consistent availability.
• Future Market Growth: Anticipate increased demand as fungal infection treatments expand, and monitor emerging suppliers in developing regions.

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FAQs

1. What are the primary regions producing terconazole API?
India and China are the leading regions manufacturing terconazole API, leveraging their extensive pharmaceutical production infrastructure and cost advantages.

2. How can buyers verify supplier quality standards for terconazole?
Request certifications such as GMP, ISO, and regulatory approvals (FDA, EMA). Conduct audits or third-party inspections and review quality documentation, including batch records and stability data.

3. Are there pivotal regulatory considerations when sourcing terconazole internationally?
Yes. Ensure the supplier complies with local and international regulations, including GMP standards, and holds necessary certifications for your target markets.

4. What risks are associated with sourcing from emerging markets?
Potential risks include variability in quality standards, regulatory changes, supply disruptions, and logistical challenges. Due diligence and regular quality audits mitigate these risks.

5. How will market trends influence future terconazole supply?
Growing demand for antifungal therapies, advances in topical formulations, and patent expirations may lead to increased supplier competition, new entrants, and price adjustments.

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References

[1] U.S. Food and Drug Administration. "Guidance for Industry: Quality Systems Approach to Pharmaceutical GMP Regulations." 2019.
[2] World Health Organization. "Prequalification of Pharmaceuticals." 2022.
[3] European Medicines Agency. "Guidelines on Good Manufacturing Practices." 2022.
[4] Market intelligence reports on antifungal pharmaceuticals.
[5] Company websites and publicly available annual reports of Glenmark, Aurobindo, Sandoz, and Mundipharma.